Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents

No. 48 in 2021

original regulation in Chinese

The chinese version shall still prevail in actuality.

Chapter I General Provisions

Article 1 In order to regulate the registration and filing of in vitro diagnostic reagents and ensure the safety, effectiveness and quality control of in vitro diagnostic reagents, these measures are formulated in accordance with the Regulations on Supervision and Administration of Medical Devices.

Article 2 In the territory of the People's Republic of China to carry out in vitro diagnostic reagents registration, filing and its supervision and management activities, the present measures shall apply.

Article 3 These measures refer to in vitro diagnostic reagents managed according to medical devices, including in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health state evaluation, reagents, kits, calibrators, quality control products for in vitro testing of human samples, which can be used alone or in combination with instruments, apparatus, equipment or systems.

In vitro diagnostic reagents for blood screening and in vitro diagnostic reagents using radionuclide markers, which are managed according to pharmaceuticals, do not fall within the scope of management of these measures.

Article 4 Registration of in vitro diagnostic reagents refers to the application for registration of in vitro diagnostic reagents by the applicant (hereinafter referred to as the applicant) in accordance with the statutory procedures and requirements, and the drug supervision and administration department will review the safety, efficacy and quality control based on scientific knowledge in accordance with laws and regulations and decide whether to approve the application.

In vitro diagnostic reagents for the record refers to in vitro diagnostic reagents for the record (hereinafter referred to as the filer) in accordance with the statutory procedures and requirements to the drug supervision and management departments to submit information for the record, the drug supervision and management departments to submit information for the record archives for inspection activities.

Article 5 The State Drug Administration is in charge of the national in vitro diagnostic reagent registration and filing management, responsible for the establishment of in vitro diagnostic reagent registration and filing management system, according to the organization of the domestic third class and the imported second class, the third class of in vitro diagnostic reagent review and approval, the imported first class of in vitro diagnostic reagent filing and related supervision and management work, the local in vitro diagnostic reagent registration and filing work supervision and guidance.

Article 6 The State Drug Administration Medical Device Technical Review Center (hereinafter referred to as the State Bureau of Device Review Center) is responsible for the technical review of the domestic third and imported second and third categories of in vitro diagnostic reagents product registration applications, applications for change of registration, renewal of registration applications, etc.

The State Drug Administration Medical Device Standards Management Center, the China Academy of Food and Drug Administration, the State Drug Administration Food and Drug Administration Food and Drug Audit and Inspection Center (hereinafter referred to as the State Bureau Audit and Inspection Center), the State Drug Administration Drug Evaluation Center, the State Drug Administration Administrative Matters Acceptance Service and Complaint Reporting Center, the State Drug Administration Information Center and other professional and technical institutions In vitro diagnostic reagents, in accordance with their responsibilities to implement the supervision and management of in vitro diagnostic reagents required for the management of in vitro diagnostic reagents standards, classification definition, testing, verification, monitoring and evaluation, certification and delivery and the corresponding information technology construction and management and other related work.

Article 7 The drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the registration and management of the following in vitro diagnostic reagents within their administrative regions.

(a) In vitro diagnostic reagent registration review and approval for the domestic second class within the territory.

(b) the verification of the quality management system of in vitro diagnostic reagents of the domestic second and third categories within the territory.

(c) the organization of medical device clinical trial institutions and the supervision and management of clinical trials in accordance with the law.

(d) the supervision and guidance of the municipal departments responsible for drug supervision and management of the territory of the domestic first class of in vitro diagnostic reagents for the record.

Provinces, autonomous regions and municipalities directly under the Central Drug Administration set up or designated medical device professional and technical institutions to undertake the implementation of in vitro diagnostic reagents supervision and management of the technical review, testing, verification, monitoring and evaluation of work required.

Municipal departments responsible for drug supervision and management shall be responsible for the record management of the first class of in vitro diagnostic reagents within the territory.

Article 8 The registration and filing of in vitro diagnostic reagents shall follow the principles of law, science, openness, fairness and justice.

Article 9 The first class of in vitro diagnostic reagents shall be subject to product record management. The second class and the third class of in vitro diagnostic reagents shall be subject to product registration management.

For the filing of the domestic first class of in vitro diagnostic reagents within the territory, the filer shall submit the filing information to the municipal department in charge of drug supervision and management at the district level.

The second class of domestic in vitro diagnostic reagents within the territory is reviewed by the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government, and a medical device registration certificate is issued after approval.

The third class of domestic in vitro diagnostic reagents within the State Drug Administration review, approval issued after the registration certificate of medical devices.

Imported first class in vitro diagnostic reagents are for the record, the filer to the State Drug Administration to submit the record information.

Imported Class II, Class III in vitro diagnostic reagents are by the State Drug Administration review, approval issued after the medical device registration certificate.

Article 10 in vitro diagnostic reagents registrant, the filer shall strengthen the whole life cycle of in vitro diagnostic reagents quality management, the development, production, operation, use of the whole process of in vitro diagnostic reagents safety, efficacy and quality control according to the responsibility.

Article 11 The State Drug Administration implements priority approval of the urgent clinical needs of in vitro diagnostic reagents and encourages the research and innovation of in vitro diagnostic reagents, and promotes the high-quality development of the medical device industry.

Article 12 The State Drug Administration establishes and improves in vitro diagnostic reagents standards, technical guidelines and other systems, standardize in vitro diagnostic reagents technical review and quality management system verification, guidance and service in vitro diagnostic reagents research and development and registration applications.

Article 13 The drug supervision and management departments share be in accordance with the timely disclosure of in vitro diagnostic reagents registration, filing-related information, the applicant can query the progress and results of approval, the public can access the approval results.

Without the consent of the applicant, the drug supervision and management department, professional and technical institutions and their staff, experts involved in the evaluation and other personnel shall not disclose the commercial secrets, undisclosed information or confidential business information submitted by the applicant or the filer, except as otherwise provided by law or in relation to national security or significant social public interests.

Chapter II Basic Requirements

Article 14 The registration and filing of in vitro diagnostic reagents shall comply with relevant laws, regulations, rules and mandatory standards, follow the basic principles of in vitro diagnostic reagent safety and performance, refer to relevant technical guidelines, prove that the registered and filed in vitro diagnostic reagents are safe, effective and of controllable quality, and ensure that the information is true, accurate, complete and traceable.

Article 15 Applicants and filers shall be enterprises or development institutions that can bear the corresponding legal responsibilities.

Foreign applicants and filers shall designate an enterprise legal person in China as an agent to handle the registration and filing of relevant in vitro diagnostic reagents. The agent shall assist the registrant or filer in fulfilling the obligations stipulated in Article 20(1) of the Regulations for the Supervision and Administration of Medical Devices, and assist the overseas registrant or filer in implementing the corresponding legal responsibilities.

Article 16 The applicant and the filer shall establish a quality management system related to the development and production of the product and maintain effective operation.

Article 17 The personnel handling the registration and filing of in vitro diagnostic reagents shall have relevant professional knowledge and be familiar with the laws, regulations, rules and registration management related to the registration and filing of in vitro diagnostic reagents.

Article 18 The application for registration or for the record, shall be in accordance with the State Drug Administration registration, filing requirements to submit relevant information, the applicant, the filer is responsible for the authenticity of the information.

Registration, filing information should be used in Chinese. According to the foreign language information translated, should also be provided in original. When citing unpublished literature, it should be provided the data rights holder permission to use the documents.

Article 19 Application for registration of imported in vitro diagnostic reagents and filing of imported in vitro diagnostic reagents shall be submitted to the competent authorities of the country (region) where the applicant, the filer's place of registration or production is located for approval of marketing.

If the product is not managed as a medical device in the country (region) where the applicant or the filer is registered or produced, the applicant or the filer shall provide relevant documents, including the documents certifying that the country (region) where the applicant or the filer is registered or produced permits the product to be marketed.

If the in vitro diagnostic reagents are not listed in the country (region) where the applicant or the filer is registered or where the production site is located in accordance with the registration procedure for innovative products, relevant documents need not be submitted.

Article 20 In vitro diagnostic reagents shall comply with the applicable mandatory standards. Product structural features, technical principles, intended use, use, etc. and the scope of application of mandatory standards are inconsistent, the applicant, the filer shall submit a statement of non-application of mandatory standards and provide relevant information.

If there is no mandatory standard, the applicant and the filer are encouraged to adopt the recommended standard.

Article 21 The registration and filing of in vitro diagnostic reagents shall follow the relevant requirements of the in vitro diagnostic reagent classification rules and classification catalogue.

Article 22 The drug supervision and management departments continue to promote the reform of the review and approval system, strengthen regulatory scientific research, establish a technical review-led, verification, testing, monitoring and evaluation of in vitro diagnostic reagent registration management technology system for support, optimize the review and approval process, improve the review and approval capabilities, and enhance the quality and efficiency of the review and approval.

Article 23 The medical device professional and technical institutions to establish and improve the communication system, clear communication form and content, according to the work needs of the organization and the applicant to communicate.

Article 24 medical device professional technical institutions according to the work needs to establish expert consultation system, in the review, verification, testing and other processes on major issues to listen to expert advice, give full play to the role of technical support of experts.

Chapter III Registration of in vitro diagnostic reagents

Section I Product Development

Article 25 The development of in vitro diagnostic reagents shall follow the principles of risk management, taking into account the existing level of recognized technology, to ensure that all known and foreseeable risks and unintended effects of the product are minimized and acceptable, and to ensure that the benefits of the product in normal use outweigh the risks.

Article 26 Research and development activities of in vitro diagnostic reagent product shall comply with the requirements of relevant laws, regulations and compulsory standards of China, etc.

Article 27 The applicant, the filer shall prepare the product technical requirements for application for registration or for filing of in vitro diagnostic reagents.

Product technical requirements mainly include functional and safety specification and testing methods for objective determination of the finished in vitro diagnostic reagents.

The third class of in vitro diagnostic reagents should be specified in the form of an appendix to the product technical requirements of the main raw materials and production process requirements.

In vitro diagnostic reagents shall comply with the technical requirements of the registered or filed products.

Article 28 The applicant, the filer shall prepare the application for registration or filing of in vitro diagnostic reagents product specification and labeling.

Instructions for use and labels shall comply with the "Supervision and Administration of Medical Devices Regulations" Article 39 requirements and related provisions.

Article 29 The development of in vitro diagnostic reagents shall be based on the intended use and technical characteristics of the products to carry out non-clinical studies of in vitro diagnostic reagents.

Non-clinical research refers to the testing or evaluation of in vitro diagnostic reagents under laboratory conditions, including the selection and preparation of major raw materials, product production processes, product analytical performance, positive judgment values or reference intervals, product stability and other research.

Application for registration or filing shall be submitted to the non-clinical evidence generated during the development activities.

Article 30 The functional and safety indicators and methods determined during the non-clinical research of in vitro diagnostic reagents shall be compatible with the intended use conditions and purposes of the products, and the research samples shall be representative and typical. When necessary, methodological validation and statistical analysis shall be conducted.

Article 31 application for registration or for the record, shall be tested in accordance with the technical requirements of the product, and submit a test report. Test qualified, before the clinical trial or application for registration, for the record.

Article 32 For same registration application including different packaging specifications, you can only carry out a packaging specification product testing, testing with products should be able to represent the application for registration or for the record product safety and efficacy, its production should be in line with the relevant requirements of the medical device production quality management practices.

Article 33 The application for registration or for the record can be self-test report, but also can be commissioned by a qualified medical device inspection agency to issue the inspection report.

Third Class in vitro diagnostic reagents should provide three different production batches of product inspection reports.

Article 34 For the applicable national standards, the national standards shall be used to test the reagents. The China Academy of Food and Drug Administration is responsible for organizing the preparation and calibration of national standards.

Section II Clinical Evaluation

Article 35 Clinical evaluation of in vitro diagnostic reagents refers to the process of using scientific and reasonable methods to analyze and evaluate clinical data to confirm whether the product meets the requirements for use or intended use, so as to prove the safety and effectiveness of in vitro diagnostic reagents.

Article 36 clinical trial of in vitro diagnostic reagents refers to the systematic study of the clinical performance of in vitro diagnostic reagents in the corresponding clinical environment.

The State Drug Administration to develop in vitro diagnostic reagents clinical trial guidelines, to clarify the requirements for conducting clinical trials, clinical trial report writing requirements, etc.

Article 37 to carry out clinical evaluation of in vitro diagnostic reagents, clinical trials should be conducted to prove the safety and effectiveness of in vitro diagnostic reagents.

Clinical trials may be exempted if the following circumstances are met.

(a) The reaction principle is clear, the design is stereotyped, the production process is mature, and the in vitro diagnostic reagents of the same species that have been marketed have been clinically applied for many years and have no record of serious adverse events and do not change their routine use.

(b) The safety and effectiveness of the in vitro diagnostic reagents can be proved by means of methodological comparison of the same species.

Exempt from clinical trials of the second class, the third class of in vitro diagnostic reagents directory by the State Drug Administration to develop, adjust and publish.

Article 38 For in vitro diagnostic reagents exempted from clinical trials, the applicant shall prove the safety and efficacy of the product through the methodological comparison of clinical samples of the same species that meet the intended use.

State Drug Administration to develop clinical evaluation of in vitro diagnostic reagents exempted from clinical trials related guidelines.

Article 39 clinical evaluation of in vitro diagnostic reagents refers to the applicant for clinical evaluation of the documents formed.

If clinical trials are conducted, the clinical trial data include clinical trial protocols, ethics committee opinions, informed consent, clinical trial reports and relevant data, etc.

For in vitro diagnostic reagents included in the catalogue of exempted clinical trials, the clinical evaluation information includes comparative analysis with similar products already on the market, methodological comparison data, analysis of relevant literature data and analysis of empirical data, etc.

Article 40 When the same registration application includes different package specifications, only one package specification may be used for clinical evaluation, and the product for clinical evaluation shall represent the safety and efficacy of the product applied for registration or for record.

Calibration products and quality control products do not need to submit clinical evaluation information when applying for registration alone.

Article 41 To carry out in vitro diagnostic reagents clinical trials, it should be in accordance with the requirements of the quality management standards for medical device clinical trials, in accordance with the appropriate conditions and in accordance with the provisions of the record of the medical device clinical trial institutions. Before the start of the clinical trial, the clinical trial sponsor shall file the clinical trial with the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government. The production of in vitro diagnostic reagents for clinical trials shall conform to the relevant requirements of the code of quality management for the production of medical devices.

Article 42 For serious adverse events related to in vitro diagnostic reagents in clinical trials during clinical trials, or other serious safety risk information, the clinical trial sponsor shall, in accordance with relevant requirements, report to the provincial, autonomous region or municipality directly under the central government drug supervision and management department of the location and clinical trial institution respectively, and take risk control measures. Failure to take risk control measures, the province, autonomous region or municipality directly under the Central Drug Administration shall order the sponsor to take appropriate risk control measures.

Article 43 In vitro diagnostic reagents clinical trials in a wide range of clinical trials of in vitro diagnostic reagents related to serious adverse events, or other major safety issues, the sponsor shall suspend or terminate the in vitro diagnostic reagents clinical trials, respectively, to the location and clinical trial institutions located in the province, autonomous region, municipality directly under the Central Drug Administration and Management Department report. If the clinical trial is not suspended or terminated, the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government shall order the sponsor to take appropriate risk control measures.

Article 44 When conducting clinical evaluation of in vitro diagnostic reagents expected to be used by consumers for personal use, the applicant shall also conduct an evaluation of the cognitive ability of consumers without medical background on the product instructions.

Article 45 For in vitro diagnostic reagents that are being used in clinical trials for diagnosing diseases that are seriously life-threatening and for which there are no effective diagnostic means, and which may benefit patients upon medical observation, after ethical review and informed consent, may be used free of charge for other patients with the same condition within the institution conducting the clinical trial of the in vitro diagnostic reagents, and their safety data may be used in the application for registration of the in vitro diagnostic reagents.

Section III Verification of Quality Management System

Article 46 The applicant shall submit information on the quality management system related to product development and production when applying for registration, and the drug supervision and management department receiving the registration application shall organize the verification of the quality management system if it is deemed necessary during the technical review of the product, and may access the original information as needed.

Article 47 The verification of the quality management system of the third class of in vitro diagnostic reagents within the territory shall be carried out by the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the applicant is located, as notified by the device review centre of the State Bureau.

The verification of the quality management system of in vitro diagnostic reagents of the second class shall be carried out by the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government where the applicant is located.

Article 48 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall carry out verification of the quality management system in accordance with the requirements of the code of quality management for the manufacture of medical devices, focusing on whether the applicant has established a quality management system in accordance with the requirements of the code of quality management for the manufacture of medical devices, as well as the design and development, production management and quality control related to the development and production of the products.

In the verification process, the authenticity of the product for testing and clinical trial products should be verified at the same time, focusing on the design and development process records, as well as the product for testing and clinical trial products production process records.

Submitted to the self-test report, the applicant, the filer or the agency entrusted with the development process of the test capabilities, test results and other key verification.

Article 49 The provinces, autonomous regions and municipalities directly under the Central Drug Administration may carry out quality management system verification by means of information review or on-site inspection. According to the specific circumstances of the applicant, supervision and inspection, the application for registration of the product and has previously passed the verification of product production conditions and process comparison, etc., to determine whether the on-site inspection and inspection content, to avoid duplication of inspection.

Article 50 The National Bureau of Equipment Review Center of the import of Class II and Class III in vitro diagnostic reagents to carry out technical review, that it is necessary to carry out quality management system verification, notify the National Bureau of Audit and Inspection Center to carry out verification according to the relevant requirements.

Section IV Product Registration

Article 51 The applicant shall, after completing the safety and efficacy studies to support the registration of in vitro diagnostic reagents and making preparations to undergo quality management system verification, submit an application for registration of in vitro diagnostic reagents and, in accordance with the relevant requirements, submit the following registration application information to the drug supervision and management department through online registration applications and other channels.

(a) Product risk analysis information.

(b) Product technical requirements.

(c) Product test reports.

(d) Clinical evaluation.

(e) Instruction for use and labeling samples.

(f) Quality management system documents related to research and development.

(g) other information required to prove the safety and effectiveness of the product.

Article 52 of the drug supervision and management department received the application to review the application information, and according to the following circumstances, respectively, to deal with.

(a) the application matters belong to the administrative organ of the terms of reference, the application information is complete, meet the requirements of the form of audit, be accepted.

(b) If there are errors in the application data that can be corrected on the spot, the applicant shall be allowed to correct them on the spot.

(c) If the application information is incomplete or does not conform to the statutory form, the applicant shall be informed on the spot or within five days of the need to make corrections in full; if the applicant is not informed after the deadline, the application shall be accepted from the date of receipt of the application information.

(d) If the application matters do not fall within the competence of the administrative organ according to law, a decision of inadmissibility shall be made immediately and the applicant shall be informed to apply to the relevant administrative organ.

Drug supervision and management departments accept or reject the application for registration of in vitro diagnostic reagents, shall issue a notice of acceptance or rejection with the special seal of the administrative organ and the date indicated.

After the application for registration of in vitro diagnostic reagents is accepted, if the applicant is required to pay the fee, the applicant shall pay the fee according to the regulations. If the applicant fails to pay the fee within the prescribed period, the applicant shall be deemed to have withdrawn the application on his own initiative and the drug supervision and management department shall terminate the registration procedure.

Article 53 of the technical review process requires the applicant to correct information, the technical review body shall inform the need to correct all the content at one time. The applicant shall, within one year after receiving the notice of correction, provide additional information in accordance with the requirements of the notice of correction; after receiving the additional information, the technical review agency shall complete the technical review within the prescribed time limit.

If the applicant disagrees with the content of the notice of correction, he/she may submit written comments to the corresponding technical review body, stating the reasons and providing the corresponding technical support information.

If the applicant fails to submit additional information after the deadline, the technical review shall be terminated and the drug supervision and management department shall make the decision not to register.

Article 54 For the accepted registration application, the applicant may, before the administrative licensing decision is made, apply to the drug supervision and administration department accepting the application to withdraw the registration application and related information, and explain the reasons. If the withdrawal of the application is agreed, the drug supervision and management department terminates its registration procedure.

Review, verification, approval process found that there is suspected of concealing the true situation or providing false information and other illegal acts, according to the law, the applicant may not withdraw the registration application.

Article 55 For the accepted registration application, if there is evidence that the registration application information may be false, the drug supervision and management department may suspend the review and approval. After verification, continue the review or make the decision of not registering according to the verification conclusion.

Article 56 During the review of in vitro diagnostic reagent registration application, the technical review agency shall inform the applicant of the reasons for not passing the review, and the applicant may raise objection to the technical review agency within 15 days, and the objection shall be limited to the original application matters and the original application information. The technical review body shall make a comprehensive assessment of the applicant's objections and provide feedback to the applicant. The objection processing time shall not be counted as part of the review time limit.

Article 57 The drug supervision and administration department receiving the registration application shall, after the completion of the technical review, make a decision on whether to approve or not. To meet the requirements of safety, effectiveness and quality control, registration shall be granted and a medical device registration certificate shall be issued, and the approved product technical requirements and product specification shall be sent to the applicant in the form of an attachment. If the registration is not granted, the reasons shall be stated in writing and the applicant shall be informed of the right to apply for administrative reconsideration or to institute administrative proceedings in accordance with the law.

Medical device registration certificate is valid for five years.

Article 58 for the accepted registration application, one of the following circumstances, drug supervision and management departments to make the decision not to register, and inform the applicant.

(a) The applicant's research on the safety, efficacy and quality control of in vitro diagnostic reagents to be marketed and sold and its results cannot prove the safety, efficacy and quality control of the product.

(b) The quality management system verification is not passed, as well as the applicant refuses to accept the quality management system on-site inspection

(c) The registration application information is false

(d) Confusing and contradictory content of the registration application data, the content of the registration application data is obviously inconsistent with the application items and cannot prove the safety, effectiveness and quality control of the product

(e) other cases of non-registration.

Article 59 of the laws, regulations, rules and regulations on the implementation of administrative licensing matters should be heard, or drug supervision and management departments believe that the need for hearing other major administrative licensing matters involving public interest, drug supervision and management departments shall be announced to the public, and hold hearings. If the application for registration of medical devices directly involves a significant relationship of interest between the applicant and others, the drug supervision and administration department shall inform the applicant and the interested party of the right to request a hearing before making the administrative licensing decision.

Article 60 For in vitro diagnostic reagents used for rare diseases, serious life-threatening diseases for which there is no effective means of diagnosis and for responding to public health events and other urgent needs, the drug supervision and management department may make a decision on conditional approval and set out in the medical device registration certificate the expiry date, the research work to be continued after listing and the time limit for completion, and other related matters.

Article 61 For in vitro diagnostic reagents with conditional approval, the registrant shall collect benefit and risk-related data after the in vitro diagnostic reagents are marketed, continuously monitor and evaluate the benefit and risk of the products, take effective measures to actively control the risk, and complete the research and submit relevant information within the specified period.

Article 62 For in vitro diagnostic reagents approved with conditions, if the registrant fails to complete the study in accordance with the requirements or fails to prove that the benefits outweigh the risks, the registrant shall promptly apply for cancellation of the medical device registration certificate, and the drug supervision and management department may cancel the medical device registration certificate in accordance with law.

Article 63 of the newly developed in vitro diagnostic reagents have not been included in the in vitro diagnostic reagent classification directory, the applicant can directly apply for the third class of in vitro diagnostic reagents product registration, but also based on the classification rules to determine the product class and apply to the State Drug Administration to confirm the class, apply for product registration or product record.

Directly apply for registration of the third class of in vitro diagnostic reagents, the State Drug Administration in accordance with the degree of risk to determine the class. Domestic in vitro diagnostic reagents identified as the second class or the first class, the applicant shall be informed to the appropriate drug supervision and management department to apply for registration or for the record.

Article 64 has been registered in vitro diagnostic reagents, its management class from the high class to adjust the low class, the medical device registration certificate continues to be valid during the validity period. If the validity period expires and needs to be renewed, the registrant shall apply for renewal of registration or filing with the corresponding drug supervision and administration department in accordance with the adjusted class six months before the expiry of the medical device registration certificate.

In vitro diagnostic reagents management class adjusted from low class to high class, the registrant shall apply for registration in accordance with the changed class to the corresponding drug supervision and management department. State Drug Administration in the management class adjustment notice should be completed to adjust the time limit to make provisions.

Article 65 medical device registration certificate and its accessories lost or destroyed, the registrant shall apply to the original issuing authority for a replacement, the original issuing authority to verify the replacement.

Article 66 In case of disputes over patent rights occurring during the examination of the registration application and after its approval, they shall be dealt with in accordance with the provisions of relevant laws and regulations.

Chapter IV Special Registration Procedures

Section I Procedures for Registration of Innovative Products

Article 67 For in vitro diagnostic reagents that meet the following requirements, the applicant may apply for the application of the innovative product registration procedure.

(a) The applicant, through its leading technological innovation activities, owns the patent right for the invention of the core technology of the product in China according to law, or has obtained the patent right for the invention in China or the right to use it through assignment according to law, and the application for the application of the innovative product registration procedure is within five years from the date of the patent grant announcement; or the application for the patent for the invention of the core technology has been made public by the patent administration department of the State Council and a search report has been issued by the Patent Search and Consulting Center of the State Intellectual Property Office, stating that the core technical solution of the product has novelty and inventiveness.

(b) The applicant has completed the preliminary research of the product and has a basically finalized product, the research process is authentic and controlled, and the research data is complete and traceable.

(c) The main working principle or mechanism of action of the product is the first of its kind in China, and the performance or safety of the product has been fundamentally improved compared with similar products, and is technically at the international leading level, and has significant clinical application value.

Article 68 For the application of innovative product registration procedures, the applicant shall, after the product is basically finalized, the State Drug Administration to submit an application for review of innovative medical devices. State Drug Administration to organize experts to review, meet the requirements, into the innovative product registration procedures.

Article 69 For the application of innovative product registration procedures for in vitro diagnostic reagents registration application, the State Drug Administration and undertake the relevant technical work of the institutions, according to their respective responsibilities to designate a person responsible for timely communication, to provide guidance.

In vitro diagnostic reagents included in the innovative product registration process, the State Bureau of device review centre and the applicant in the registration application before acceptance and the technical review process on the product development of major technical issues, major safety issues, clinical trial protocols, the summary and evaluation of the results of phase clinical trials and other issues communication.

Article 70 At the innovative product registration process of in vitro diagnostic reagents, the applicant took the initiative to request the termination or the State Drug Administration found that no longer meet the requirements of the innovative product registration process, the State Drug Administration can terminate the relevant products and inform the applicant of the innovative product registration process.

Article 71 At the innovative product registration procedures of in vitro diagnostic reagents, the applicant does not apply for registration within the specified period, no longer apply to innovative product registration procedures.

Section II Priority Registration Procedures

Article 72 In vitro diagnostic reagents that meet one of the following circumstances may apply for the application of priority registration procedures.

(a) Diagnosis of rare diseases and malignant tumors with obvious clinical advantages, diagnosis of diseases specific to the elderly and multiple diseases with no effective diagnostic means at present, dedicated to children with obvious clinical advantages, or medical devices that are in urgent clinical need and no products of the same species have been approved for registration in China.

(b) included in the national science and technology major special projects or national key research and development programs of medical devices.

(c) the State Drug Administration provisions of other priority registration procedures can be applied to medical devices.

Article 73 to apply for priority registration procedures, the applicant shall apply for registration of in vitro diagnostic reagents in the application to the State Drug Administration to apply for priority registration procedures. Belong to the first case of Article 72, the State Drug Administration to organize experts to review, in line with the priority registration procedures; belong to the second case of Article 72, the State Bureau of device review centre to review, in line with the priority registration procedures; belong to the third case of Article 72, the State Drug Administration to listen to a wide range of views, and the organization of expert evidence to determine Whether to include priority registration procedures.

Article 74 For the priority registration procedures for in vitro diagnostic reagents into the registration application, the State Drug Administration provides priority for review and approval. Provinces, autonomous regions, municipalities directly under the Central Drug Administration a well provide priority arrangements for registration quality management system verification.

National Bureau of device review centre in the priority registration procedures for medical devices included in the technical review process, should be in accordance with relevant provisions to actively communicate with the applicant, if necessary, can arrange special exchanges.

Section III emergency registration procedures

Article 75 The State Drug Administration may be required by law for emergency public health emergencies and there is no similar product listed in China, or although there is a similar product listed in China but the product supply can not meet the emergency needs of public health emergencies in vitro diagnostic reagents to implement emergency registration.

Article 76 To apply for emergency registration procedures, the applicant shall apply to the State Drug Administration for emergency registration. Meet the conditions, into the emergency registration procedures.

Article 77 For the implementation of emergency registration of in vitro diagnostic reagent registration application, the State Drug Administration share be in accordance with the unified command, early intervention, with the review, scientific approval requirements for parallel in vitro diagnostic reagent product testing, system verification, technical review and other work.

Chapter V Change of registration and renewal of registration

Section I change of registration

Article 78 The registrant shall take the initiative to conduct post-marketing research on in vitro diagnostic reagents, further confirm the safety, efficacy and quality control of in vitro diagnostic reagents, and strengthen the continuous management of listed in vitro diagnostic reagents.

For registered Class II and Class III in vitro diagnostic reagent products, if substantial changes occur in their design, raw materials, production process, scope of application and method of use, which may affect the safety and effectiveness of the in vitro diagnostic reagent, the registrant shall apply to the original registration department for change of registration procedures; if other changes occur, they shall be filed with the original registration department within 30 days from the date of change.

The product name, packaging specification, main component, intended use, technical requirements of the product, product specification, production address of the imported in vitro diagnostic reagent, etc. contained in the registration certificate belong to the significant matters of change registration. The name and address of the registrant, the name and address of the Chinese agent, etc., belong to the administration matters of change registration. In the case of a change of address for the production of domestic in vitro diagnostic reagents, the registrant shall apply for filing after handling the corresponding change of production license.

In case of other changes, the registrant shall do the relevant work in accordance with the requirements of the quality management system and report to the drug supervision and management department in accordance with the provisions.

Article 79 For registered class II, class III in vitro diagnostic reagents, the core technical principles of the product, such as substantial changes, or other significant changes, a significant impact on the safety and effectiveness of the product, in essence, make a new product, does not belong to this chapter of the application for change matters, should be in accordance with the provisions of the registration application.

Article 80 for the change of registration application, the technical review body shall focus on the change part of the review, the change of the product is safe, effective, quality control to form a review opinion.

In the technical review of the change of registration application, it is considered necessary to verify the quality management system, the drug supervision and management department shall organize the verification of the quality management system.

Article 81 Change notifications of medical device and the original medical device registration certificate should be used in combination. The expiry date is the same as the original medical device registration certificate.

Section II renewal of registration

Article 82 of the medical device registration certificate expires need to renew the registration, the registrant shall, six months before the expiry of the medical device registration certificate, apply to the original registration department for renewal of registration and submit the application information in accordance with the relevant requirements.

Except for the circumstances stipulated in Article 83 of these Measures, the drug supervision and management department receiving the application for renewal of registration shall make a decision to grant the renewal before the expiry of the medical device registration certificate. If the decision is not made after the expiry date, the renewal shall be deemed to be granted.

Article 83 shall not be renewed if one of the following circumstances exists.

(a) Failure to apply for renewal of registration within the prescribed period.

(b) If the new in vitro diagnostic reagents mandatory standards or national standards issued and implemented, the application for renewal of registration of in vitro diagnostic reagents can not meet the new requirements.

(c) With the approval of the conditions of in vitro diagnostic reagents, not within the prescribed period of time to complete the medical device registration certificate contains matters.

Article 84 If approved time at renewal is within the original registration certificate validity, the renewal of registration of the registration certificate validity date for the next day of the original registration certificate expiry date; approved time is not within the original registration certificate validity date, the renewal of registration of the registration certificate validity date for the start of the approved renewal of registration date.

Article 85 In vitro diagnostic reagents change registration application, renewal of registration application acceptance and approval procedures, this chapter does not provide for, the relevant provisions of Chapter III of these measures shall apply.

Chapter VI In Vitro Diagnostic Reagents Filing

Article 86 The first class of in vitro diagnostic reagents shall be filed before production.

Article 87 For in vitro diagnostic reagents for the record, the filer shall be in accordance with the provisions of the Regulations for the Supervision and Administration of Medical Devices, submit the filing information to the drug supervision and administration department and obtain a filing number.

Article 88 For filed in vitro diagnostic reagents, if the record information table and the record of the product technical requirements have changed, the filer shall change the record to the original filing department, and submit a description of the changes and related documents. The drug supervision and management department shall post the changes in the record information.

Article 89 The management class of the filed in vitro diagnostic reagents shall be adjusted to the second or third class of in vitro diagnostic reagents, and shall apply for registration in accordance with the provisions of these Measures.

Chapter VII Working Time Limit (review time)

Article 90 The time limit stipulated in these Measures is the maximum time for the acceptance, technical review, verification and approval of in vitro diagnostic reagent registration. Special registration procedures related to the work time limit, in accordance with the relevant provisions of the special registration procedures.

The National Bureau of Equipment Review Center and other professional and technical institutions shall clarify the work procedures and time limits of their units and make them public.

Article 91 After receiving the application for registration of in vitro diagnostic reagents, the drug supervision and administration department shall forward the application information to the technical review institution within three days from the date of acceptance.

Article 92 The time limit for technical review of in vitro diagnostic reagent registration shall be implemented in accordance with the following provisions.

(a) For second class of in vitro diagnostic reagent registration application, technical review of change of registration application, renewal of registration application is 60 days, the application information after correction of the technical review is of 60 days.

(b) For third class of in vitro diagnostic reagent registration application, technical review of change of registration application, renewal of registration application is 90 days, the application information after correction of the technical review is of 60 days.

Article 93 The time limit for verification of the quality management system of the third class of in vitro diagnostic reagents within the territory shall be implemented in accordance with the following provisions.

(a) The National Bureau of Equipment Review Center shall notify the relevant provinces, autonomous regions and municipalities directly under the Central Drug Administration within 10 days after the acceptance of the application for registration of in vitro diagnostic reagents to initiate verification.

(b) Provinces, autonomous regions and municipalities directly under the Central Drug Administration shall, in principle, complete the verification within 30 days after receiving the notification of verification, and feedback the verification situation, verification results and other relevant materials to the National Bureau of Device Evaluation Center.

Article 94 The drug supervision and management department receiving the registration application shall make a decision within 20 days from the date of receipt of the review comments.

Article 95 The drug supervision and management department shall issue and deliver the relevant administrative license documents within 10 days from the date of making the decision on the approval of in vitro diagnostic reagent registration.

Article 96 Due to product characteristics and technical review, verification and other work encountered special circumstances really need to extend the time limit, the extension of the time limit shall not exceed one-half of the original time limit, approved by the medical device technical review, verification and other relevant technical institutions, the extension of the time limit by the technical institutions to inform the applicant in writing, and notify other relevant technical institutions.

Article 97 The original issuing authority shall issue a replacement medical device registration certificate within 20 days from the date of receipt of the application.

Article 98 The following time shall not be counted in the relevant work time limit.

(a) The time taken by the applicant to supplement information, rectification after verification, etc.

(b) The time taken up by delayed verification due to the applicant

(c) The time taken for external expert consultation, convening expert consultation meetings and the need for joint reviews with drug review agencies

(d) Time taken up during the suspension of the review and approval process if the review and approval process is suspended in accordance with the provisions

(d) The time taken up by the verification of the quality management system.

Article 99 The time limits specified in these Measures shall be calculated in working days.

Chapter VIII Supervision and management

Article 100 The drug supervision and management departments shall strengthen the supervision and inspection of in vitro diagnostic reagent development activities, when necessary, can provide products or services for the development of in vitro diagnostic reagents units and individuals to extend the inspection, the relevant units and individuals shall cooperate, provide relevant documents and information, shall not refuse, conceal, obstruct.

Article 101 The State Drug Administration to establish and step-by-step implementation of the unique identification system for medical devices, the applicant, the filer should be submitted in accordance with the relevant provisions of the unique identification-related information to ensure that the data is true, accurate and traceable.

Article 102 The State Drug Administration shall promptly notify the agent information to the agent's location of the province, autonomous region, municipality directly under the Central Drug Administration. Provinces, autonomous regions, municipalities directly under the Central Drug Administration to the administrative region of the agent organization to carry out daily supervision and management.

Article 103 The drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government according to the medical device clinical trial institutions for the record, the organization has been filed in the administrative region of the clinical trial institutions to carry out post-filing supervision and inspection. For the newly filed medical device clinical trial institutions, shall carry out supervision and inspection within 60 days after filing.

Provinces, autonomous regions and municipalities directly under the Central Drug Administration shall organize daily supervision and inspection of medical device clinical trial institutions in their administrative regions to comply with the quality management standards for medical device clinical trials and monitor their continued compliance with the requirements. The State Drug Administration shall carry out supervision and inspection of medical device clinical trial institutions as needed.

Article 104 The drug supervision and administration department may, if deemed necessary, conduct on-site inspection of the authenticity, accuracy, completeness, standardization and traceability of clinical trials.

Article 105 The drug supervision and administration department that undertakes the filing of the first class in vitro diagnostic reagent products shall, in the post-filing supervision, order the filer to rectify the irregularities in the filing information.

Article 106 The drug supervision and administration department that fails to timely discover the systemic or regional risks in the registration and management of in vitro diagnostic reagents in its administrative region, or fails to timely eliminate the systemic or regional hidden dangers in the registration and management of in vitro diagnostic reagents in its administrative region, the higher-level drug supervision and administration department may interview the main person in charge of the lower-level drug supervision and administration department.

Chapter IX Legal Liability

Article 107 Violation of the provisions of Article 78 of these Measures, failure to file changes in accordance with the requirements, shall be ordered to rectify within a period of time; if it fails to do so, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed.

Article 108 The conduct of in vitro diagnostic reagents clinical trials that do not comply with the clinical trial quality management norms, in accordance with the "Regulations for the Supervision and Administration of Medical Devices" Article 94 shall be punished.

Article 109 medical device technical review agencies do not perform their duties in accordance with the provisions of these measures, resulting in major errors in the review, the department responsible for drug supervision and management shall order rectification, inform criticism, give a warning; if serious consequences are caused, the legal representative of the offending unit, the main person in charge, the person in charge directly responsible and other responsible personnel, shall be punished in accordance with law.

Article 110 The staff of the department responsible for the supervision and administration of drugs who violate the provisions, abuse their powers, neglect their duties or commit corruption shall be punished in accordance with law.

Chapter X By-laws

Article 111 The naming of in vitro diagnostic reagents shall follow the following principles.

The product name of in vitro diagnostic reagents generally consists of three parts. The first part: the name of the substance to be measured; the second part: the use, such as assay kits, quality control products, etc.; the third part: the method or principle, such as magnetic particle chemiluminescence immunoassay, fluorescent PCR method, fluorescent in situ hybridization method, etc. This part should be listed in parentheses.

If there are more components of the test substance or other special circumstances, the name of the indication associated with the product or other alternative names may be used.

Class I products and calibrators and quality control products are named according to their intended use.

Article 112 The registration or filing unit of in vitro diagnostic reagents shall be a single reagent or a single reagent kit, and a registration or filing unit may include different packaging specifications.

Calibration products and quality control products may be combined with in vitro diagnostic reagents for registration, or they may apply for registration separately.

Article 113 The in vitro diagnostic reagents approved for registration refer to the in vitro diagnostic reagents produced within the validity period of the medical device registration certificate and the limited contents of the medical device registration certificate.

Article 114 The independent reagent components specified in the "main components" column of the medical device registration certificate may be sold separately if they are used in the original registered products.

Article 115 In applying for registration or change of registration of in vitro diagnostic reagents, the applicant may be authorized by the owner of the master file of the medical device to quote the master file of the registered medical device. The owner or agent of the master medical device document shall handle the registration, and the relevant work procedures shall be separately stipulated.

Article 116 medical device registration certificate format by the State Drug Administration unified development.

The registration certificate number is arranged as follows

×1械注×2 ××××3 ×4 ××5 ××××6

×1 is the abbreviation of the location of the registration approval department.

Domestic Class III in vitro diagnostic reagents, imported Class II and Class III in vitro diagnostic reagents are "国".

The abbreviation of the province, autonomous region or municipality directly under the Central Government where the registration and approval department is located for the second class of in vitro diagnostic reagents within the country.

×2 is the form of registration.

The word "准" applies to in vitro diagnostic reagents domestic.

The word "进" applies to imported in vitro diagnostic reagents.

The character "許" is applicable to in vitro diagnostic reagents in Hong Kong, Macao and Taiwan.

××××3 is the year of first registration.

×4 is the product class.

××5 is the product classification code.

××××6 is the first registration stream number.

For renewal of registration, the numbers of ××××3 and ××××6 remain unchanged. If the product class is adjusted, it shall be renumbered.

Article 117 The filing number of class I products shall be arranged as follows

×1械备 ××××2 ××××3.

Where.

×1 is the abbreviation of the location of the filing department.

Imported Class I in vitro diagnostic reagents for the word "国".

Domestic Class I in-vitro diagnostic reagents are the abbreviation of the province, autonomous region or municipality directly under the Central Government where the filing department is located plus the abbreviation of the municipal administrative region where the location is set up (there is no corresponding municipal administrative region set up)

××××2 is the year of filing.

××××3 is the record running number.

Article 118 drug supervision and management departments to produce medical device registration certificate, change the registration documents electronic documents and paper documents have the same legal effect.

Article 119 according to the work needs, the State Drug Administration can be entrusted by law to the provinces, autonomous regions, municipalities directly under the Central Drug Administration or technical institutions, social organizations to undertake the specific work.

Article 120 provinces, autonomous regions, municipalities directly under the Central Drug Administration can refer to the provisions of Chapter IV of these measures to develop the administrative region of the second class in vitro diagnostic reagents special registration procedures, and reported to the State Drug Administration for the record.

Article 121 In vitro diagnostic reagents product registration fee items, fees and charges in accordance with the State Council financial and price departments in charge of the relevant provisions.

Article 122 The emergency use of in vitro diagnostic reagents of the relevant provisions, by the State Drug Administration in conjunction with the relevant departments to develop separately.

Article 123 of the domestic market does not yet have the same species of products, medical institutions according to the clinical needs of their own development, in the unit under the guidance of a licensed physician in the use of in vitro diagnostic reagents, the relevant management regulations by the State Drug Administration in conjunction with the relevant departments.

Article 124 Hong Kong, Macao and Taiwan in vitro diagnostic reagents registration, filing, with reference to imported in vitro diagnostic reagents for.

Article 125 These measures shall come into force on October 1, 2021. The former State Food and Drug Administration Order No. 5 announced the "in vitro diagnostic reagents registration management measures" (30 July 2014) shall be repealed at the same time