Administrative Measures for Medical Device Registration and Filing

Tags: Classification, Product technical requirement, Type testing, instruction for use and label, innovative products, QMS, imported Class II and Class III medical device, Clinical Evaluation, clinical trial, product change, Product registration, Change registration, Renewal, technical review, medical device certificate

Chapter 1 General rules

Chapter 2 Basic requirements

Chapter 3 Registration of medical devices

Chapter 4 Product registration

Chapter 5 Change of registration and renewal of registration

Chapter 6 Filing of medical devices

Chapter 7 Time frame for registration

Chapter 8 Supervision and management

Chapter 9 Legal liability

Chapter 10 Annexes

Chapter I. General rules

Article 1 In order to regulate the registration and filing of medical devices, to ensure the safety, effectiveness and quality control of medical devices, according to the "Regulations for the Supervision and Administration of Medical Devices", to develop these measures.

Article 2 in the People's Republic of China engaged in medical device registration, filing and its supervision and management activities, the application of these measures.

Article 3 medical device registration refers to the medical device registration applicant (hereinafter referred to as the applicant) in accordance with the statutory procedures and requirements of the application for registration of medical devices, drug supervision and management departments in accordance with laws and regulations, based on scientific knowledge, safety, effectiveness and quality control and other reviews, to decide whether to agree to its application activities.

Medical device filing refers to the medical device filer (hereinafter referred to as the filer) in accordance with the statutory procedures and requirements to the drug regulatory authority to submit the record information, the drug regulatory authority to submit the record information filed for inspection activities.

Article 4 the State Drug Administration in charge of the national medical device registration and filing management, responsible for the establishment of medical device registration and filing management system and system, according to the organization of the third class and the import of Class II, Class III medical device review and approval, the import of Class I medical devices for the record and related supervision and management, the local medical device registration and filing supervision and guidance.

Article 5 of the State Drug Administration Medical Device Technical Review Center (hereinafter referred to as the State Bureau of Device Review Center) is responsible for the clinical trial approval of medical device clinical trial applications and domestic Class III and imported Class II and Class III medical device product registration applications, change of registration applications, renewal of registration applications and other technical review work.

State Drug Administration Medical Device Standards Management Center, China Institute of Food and Drug Testing, 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), State Drug Administration Drug Evaluation Center, State Drug Administration Administrative Matters Acceptance Service and Complaint Reporting Center, State Drug Administration Information Center and other professional and technical institutions According to the responsibilities of the implementation of medical device supervision and management of medical device standards management, classification definition, inspection, verification, monitoring and evaluation, certification delivery and the corresponding information construction and management and other related work.

Article 6 The drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the registration-related management of the following medical devices within their administrative regions.

(i) Review and approval of registration of Class II medical devices within the territory.

(ii) Verification of quality management systems for Class II and Class III medical devices within the territory.

(iii) 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 departments responsible for drug supervision and management at the municipal level within the territory of the first class medical device filing.

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 medical device supervision and management of the necessary technical review, inspection, verification, monitoring and evaluation of work.

The municipal department responsible for drug supervision and management is responsible for the record management of Class I medical device products within the territory.

Article 7 medical device registration and record management follow the principles of law, science, openness, fairness and justice.

Article 8 of the first class medical devices to implement product record management. Class II and Class III medical devices shall be managed by product registration.

The filing of Class I medical devices within the territory, the filer submits the filing information to the municipal department responsible for drug supervision and management in the district.

Domestic Class II medical devices are reviewed by the drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government, and a medical device registration certificate is issued after approval.

Domestic Class III medical devices are reviewed by the State Drug Administration and issued a medical device registration certificate after approval.

Imported Class I medical devices for the record, the filer submits filing information to the State Drug Administration.

Imported Class II and Class III medical devices are reviewed by the State Drug Administration and issued with medical device registration certificates after approval.

Article 9 the medical device registrant, the filer shall strengthen the quality management of the entire life cycle of medical devices, the development, production, operation, use of the entire process of medical device safety, effectiveness and quality control according to law.

Article 10 of the State Drug Administration to implement priority approval of medical devices in urgent clinical need, the implementation of special approval of innovative medical devices to encourage research and innovation of medical devices, and promote the development of medical device industry of high quality.

Article 11 the State Drug Administration to establish and improve medical device standards, technical guidelines and other systems to regulate the technical review of medical devices and quality management system verification, guidance and services for medical device research and development and registration applications.

Article 12 the drug supervision and management departments in accordance with the law and timely public medical device 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 commercial secrets, undisclosed information or confidential business information submitted by the applicant or the person of record, except as otherwise provided by law or where national security or significant social public interests are involved.

Chapter II. Basic requirements

Article 13 medical device registration, filing shall comply with relevant laws, regulations, rules and mandatory standards, follow the basic principles of medical device safety and performance, with reference to relevant technical guidelines to prove that the registered and filed medical devices are safe, effective and quality controllable, to ensure that the whole process information is true, accurate, complete and traceable.

Article 14 applicants and filers shall be enterprises or development institutions capable of assuming appropriate 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 medical devices. The agent shall assist the registrant or filer in fulfilling the obligations stipulated in paragraph 1 of Article 20 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 15 The applicant, the filer shall establish a quality management system appropriate to the product, and maintain effective operation.

Article 16 for medical device registration, filing matters should have the appropriate professional knowledge, familiar with medical device registration, filing management of laws, regulations, rules and registration management related provisions.

Article 17 of the application for registration or for the record, should be in accordance with the State Drug Administration on registration, filing requirements to submit relevant information, the applicant, the filer is responsible for the authenticity of the information.

Registration and filing materials shall be in Chinese. If the translation is based on foreign language materials, the original language shall be provided at the same time. When citing unpublished literature, the document of permission for use by the right holder of the information shall be provided.

Article 18  the application for registration of imported medical devices, for the record of imported medical devices, should be submitted to the applicant, the filer's place of registration or production in the country (region) competent authorities to permit the medical device on the market sales documents.

If the applicant or the filer's country (region) of registration or production does not manage the product as a medical device, the applicant or the filer shall provide relevant documents, including the document certifying that the country (region) of registration or production permits the product to be marketed and sold.

Innovative medical devices that are not marketed in the country (region) where the applicant, filer is registered or where the production site is located are not required to submit relevant documents.

Article 19 medical devices shall comply with the applicable mandatory standards. Product structural features, intended use, use, etc. and the scope of application of mandatory standards are inconsistent, the applicant, the filer shall submit a statement of non-applicable mandatory standards and provide relevant information.

Where there are no mandatory standards, applicants and filers are encouraged to adopt the recommended standards.

Article 20 medical device registration, filing work shall follow the relevant requirements of the medical device classification rules and classification catalog.

Article 21 The drug supervision and management departments continue to promote the reform of the review and approval system, strengthen scientific research on medical device supervision, establish a technical review-led, verification, inspection, monitoring and evaluation of medical device registration and management technology system, optimize the review and approval process, improve review and approval capabilities, and enhance the quality and efficiency of review and approval.

Article 22 The medical device professional and technical institutions to establish and improve the communication system, clear the form and content of communication, according to the work needs of the organization and the applicant to communicate.

Article 23 medical device professional and technical institutions in accordance with the needs of the work of the establishment of expert consultation system, in the review, verification, inspection 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 medical devices

Section I. Product development

Article 24 medical device development should follow the principles of risk management, taking into account the current state of accepted 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 outweigh the risks in normal use.

Article 25 engaged in medical device product development and experimental activities, shall comply with the relevant laws, regulations and mandatory standards and other requirements of China.

Article 26 The applicant, the filer shall prepare an application for registration or for the filing of medical devices product technical requirements.

The product technical requirements mainly include functional and safety indicators and testing methods that can be objectively determined for finished medical devices.

Medical devices should comply with the technical requirements of the registered or filed products.

Article 27 The applicant, the filer shall prepare an application for registration or for the filing of medical devices product specification and labeling.

Product instructions and labels shall comply with the requirements of Article 39 of the Regulations for the Supervision and Administration of Medical Devices and related regulations.

Article 28 medical device development, should be based on the scope of application of the product and technical characteristics of medical devices non-clinical research.

Non-clinical studies include product chemical and physical properties studies, electrical safety studies, radiation safety studies, software studies, biological characterization studies, biogenic material safety studies, disinfection and sterilization process studies, animal testing studies, stability studies, etc.

Applications for registration or filing should be submitted with non-clinical evidence generated from the development activities, including a review of non-clinical study reports, study protocols and study reports.

Article 29 The functional and safety indicators and methods determined in the process of non-clinical research of medical devices shall be compatible with the intended conditions of use and purpose of the products, and the research samples shall be representative and typical. When necessary, methodological validation and statistical analysis shall be conducted.

Article 30 application for registration or for the record, shall be tested in accordance with the technical requirements of the product, and submit an inspection report. If the test is qualified, the clinical trial or application for registration or filing can be carried out.

Article 31 test products should be able to represent the application for registration or for the record product safety and effectiveness, and its production should be in line with the relevant requirements of the medical device production quality management practices.

Article 32 The application for registration or for the record to submit the medical device product inspection report can be the applicant, the filer's self-test report, but also can be commissioned by a qualified medical device inspection agency issued the inspection report.

Section II Clinical Evaluation

Article 33 In addition to the circumstances specified in Article 34 of these measures, medical device product registration, filing, clinical evaluation shall be conducted.

Clinical evaluation of medical devices refers to the activity of analyzing and evaluating clinical data using scientific and reasonable methods to confirm the safety and effectiveness of medical devices within their scope of application.

Application for registration of medical devices should be submitted with clinical evaluation information.

Article 34 exempts from clinical evaluation any of the following circumstances.

(i) The working mechanism is clear, the design is well established, the production process is mature, the same species of medical devices that have been marketed have been clinically used for many years and have no record of serious adverse events and do not change their routine use.

(ii) Other non-clinical evaluations that can demonstrate the safety and effectiveness of the medical device.

Exemptions from clinical evaluation may be granted for the submission of clinical evaluation information.

The catalogue of medical devices exempted from clinical evaluation is formulated, adjusted and published by the State Drug Administration.

Article 35 to carry out clinical evaluation of medical devices, can be based on product characteristics, clinical risks, existing clinical data and other circumstances, by conducting clinical trials, or through the same species of medical devices clinical literature, clinical data analysis and evaluation, to prove the safety and effectiveness of medical devices.

In accordance with the provisions of the State Drug Administration, the clinical evaluation of medical devices, the available clinical literature, clinical data is not sufficient to confirm the safety and effectiveness of the product of medical devices, should be carried out clinical trials.

The State Drug Administration has formulated guidelines for clinical evaluation of medical devices to clarify the requirements for clinical evaluation through clinical literature information and clinical data of the same species of medical devices, the circumstances requiring clinical trials, and the requirements for writing clinical evaluation reports, etc.

Article 36 clinical evaluation through the same species of medical device clinical literature information, clinical data, clinical evaluation information including the application for registration of the product and the same species of medical devices, the same species of medical devices, the analysis and evaluation of clinical data, the application for registration of the product and the same species of products when there are differences in scientific evidence and evaluation conclusions.

If clinical evaluation is conducted through clinical trials, clinical evaluation information includes clinical trial protocols, ethics committee opinions, informed consent forms, clinical trial reports, etc.

Article 37 to carry out clinical trials of medical devices, should be in accordance with the requirements of the medical device clinical trial quality management standard, 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 administration department of the province, autonomous region or municipality directly under the Central Government. The production of clinical trial medical devices shall comply with the relevant requirements of the Code of Quality Management for the Production of Medical Devices.

Article 38 of the third category of medical devices for clinical trials on the human body has a higher risk, should be approved by the State Drug Administration.

Clinical trial approval refers to the process by which the State Drug Administration, based on the applicant's application, conducts a comprehensive analysis of the degree of risk of the medical device to be tested in clinical trials, the clinical trial protocol, and the report on the comparative analysis of clinical benefit and risk, in order to decide whether to agree to conduct clinical trials.

The third category of medical devices subject to clinical trials for approval is formulated, adjusted and published by the State Drug Administration. Clinical trials of Class III medical devices subject to clinical trial approval shall be conducted in Class III Class A medical institutions that meet the requirements.

Article 39 of the need for clinical trials of medical devices for approval, the applicant shall submit the application information such as review data, research data, clinical data, product specification and labeling samples in accordance with the relevant requirements.

Article 40 The National Bureau Device Review Center shall review the accepted clinical trial applications. The decision on whether to agree or not to agree to the clinical trial application shall be made within 60 days from the date of acceptance of the application, and the applicant shall be notified through the website of the Device Review Center of the National Bureau. If the applicant is not notified after the deadline, it shall be regarded as consent.

Article 41 If the applicant is required to make corrections during the review process, the National Bureau of Device Review Centre shall inform the applicant of all the corrections required at one time. The applicant shall, within one year of receiving the notice of correction, provide additional information in accordance with the requirements of the notice of correction. Upon receipt of the additional information, the National Bureau's device review centre shall complete the technical review in accordance with the prescribed time limit.

If the applicant disagrees with the content of the correction notice, he or she may submit written comments to the National Bureau of Device Review Center, stating the reasons and providing the corresponding technical support information.

If the applicant fails to submit additional information after the deadline, the technical review is terminated and a decision of non-approval is made.

Article 42 for medical devices during clinical trials of serious adverse events related to clinical trial medical devices, or other serious safety risk information, clinical trial sponsors shall, in accordance with the relevant requirements, respectively, to the location and clinical trial institutions in the province, autonomous region, municipality directly under the Central Drug Administration report, and take risk control measures. If risk control measures are not taken, 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 43 of the medical device clinical trials in a wide range of clinical trials of medical devices related to serious adverse events, or other major safety issues, the sponsor shall suspend or terminate the clinical trials of medical devices, respectively, to the location and clinical trial institutions located in the provinces, autonomous regions and municipalities directly under the Central Drug Administration and Management Department report. Failure to suspend or terminate, the provincial, autonomous region or municipality directly under the Central Drug Administration shall order the sponsor to take appropriate risk control measures.

Article 44 has been approved to carry out clinical trials, one of the following circumstances, the State Drug Administration may order the applicant to terminate the clinical trials of medical devices have been carried out.

(i) False information on clinical trial applications.

(ii) Where recent studies have confirmed the ethical and scientific validity of the originally approved clinical trial.

(iii) Other circumstances warranting termination.

Article 45 The clinical trial of medical devices shall be implemented within 3 years after approval; if no subject has signed the informed consent within 3 years from the date of approval of the application for clinical trial of medical devices, the permit for the clinical trial of medical devices shall expire by itself. If the clinical trial is still needed, a new application shall be made.

Article 46 For medical devices undergoing clinical trials for the treatment of serious life-threatening diseases for which there is no effective treatment, which may benefit patients after medical observation, may be used free of charge for other patients with the same condition within the institution conducting the clinical trial of the medical device after ethical review and informed consent, and their safety data may be used for medical device registration applications.

Section III. Verification of the registration system

Article 47 The applicant shall submit an application for registration and product development, production-related quality management system information, accept the application for registration of drug supervision and management departments in the technical review of the product that it is necessary to verify the quality management system, should be organized to carry out quality management system verification, and can access the original information as needed.

Article 48 The verification of the quality management system of Class III medical devices within the territory shall be notified by the National Bureau of Device Review Center to the provincial, autonomous region or municipality directly under the Central Drug Administration of the applicant's location.

Verification of the quality management system of Class II medical devices within the territory shall be organized 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 49 The provincial, autonomous regions, municipalities directly under the Central Drug Administration in accordance with the requirements of the medical device production quality management standard to carry out quality management system verification, focusing on whether the applicant in accordance with the requirements of the medical device production quality management standard to establish a quality management system appropriate to the product, as well as product development, production-related design and development, production management, quality control and other content for verification.

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

The submission of self-test report, the applicant, the person of record or the entrusted agency to develop the process of testing capabilities, test results and other key verification.

Article 50 provinces, autonomous regions and municipalities directly under the Central Drug Administration can carry out quality management system verification by means of data 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, to determine whether the on-site inspection and inspection content, to avoid duplication of inspection.

Article 51 The National Bureau of Equipment Review Center for imported Class II and Class III medical devices 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 in accordance with the relevant requirements to carry out verification.

Chapter IV. Product registration

Article 52 The applicant shall, after completing the safety and efficacy studies supporting the registration of medical devices and preparing for the verification of the quality management system, submit an application for registration of medical devices and, in accordance with the relevant requirements, submit the following registration application information to the drug regulatory authority through online registration applications and other means.

(i) Information on product risk analysis.

(ii) Product technical requirements.

(iii) Product inspection reports.

(iv) Clinical evaluation information.

(v) Product instructions and sample labels.

(vi) Quality management system documents related to product development and production.

(vii) Other information required to prove the safety and effectiveness of the product.

Article 53 the drug supervision and management department received the application to review the application information, and according to the following circumstances to make separate processing.

(a) The application shall be accepted if it falls within the competence of the administrative organ and if the application information is complete and meets the requirements for formal examination.

(ii) 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 not so informed, the application shall be accepted from the date of receipt of the application information.

(d) If the application does not fall within the competence of the administrative organ in accordance with the 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 to accept or reject the application for registration of medical devices, shall be issued under the special seal of the administrative organ and the date of the notice of acceptance or non-acceptance.

After the application for registration of medical devices is accepted, if the applicant is required to pay the fee, the applicant shall pay the fee in accordance with 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.

Where the technical review process requires the applicant to make corrections, the technical review body shall inform the applicant of all the corrections required in one go. The applicant shall, within one year of receipt of the notification of corrections, provide the additional information at one time in accordance with the requirements of the notification of corrections; upon receipt of the additional information, the technical review body shall complete the technical review within the prescribed time limit.

If the applicant disagrees with the content of the notice of correction, he or 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 is terminated and the drug regulatory authority makes a decision not to register the applicant.

Article 55 For the accepted application for registration, the applicant may, before the administrative licensing decision is made, apply to the drug supervision and administration department receiving the application to withdraw the application for registration and related information, and state the reasons. Agree to withdraw the application, the drug supervision and management department to terminate its registration procedures.

The review, verification and 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 shall not withdraw the medical device registration application.

Article 56 for the accepted registration application, there is evidence that the registration application information may be false, drug supervision and management departments may suspend the review and approval. After verification, the review shall be continued or a decision not to register shall be made in accordance with the conclusion of the verification.

Article 57 During the review of medical device registration applications, the technical review body shall inform the applicant of the reasons for not passing the review, and the applicant may raise objections to the technical review body within 15 days, which shall be limited to the original application and the original application data. The technical review body shall make a comprehensive assessment in conjunction with 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 58 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. To meet the requirements of safety, effectiveness and quality control, registration shall be granted and the medical device registration certificate shall be issued, and the approved technical requirements of the product shall be sent to the applicant in the form of an attachment. In the case of non-registration, 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.

The medical device registration certificate is valid for 5 years.

Article 59 For the accepted registration application, the drug supervision and management department shall make a decision not to register and inform the applicant if any of the following circumstances apply.

(a) The applicant's research on the safety, effectiveness and quality control of the medical device to be marketed and sold and its results cannot prove the safety, effectiveness and quality control of the product.

(b) Failure of quality management system verification, and refusal of the applicant to accept on-site inspection of the quality management system.

(c) False information on the application for registration.

(d) Confusion and contradiction in the content of the registration application data, the content of the registration application data is clearly inconsistent with the items applied for and cannot prove that the product is safe, effective and of controllable quality.

(e) Other cases of non-registration.

Article 60 the laws, regulations, rules and regulations on the implementation of administrative licensing shall be heard, or drug supervision and management departments believe that the need for a hearing on 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 the significant interests between the applicant and others, the drug supervision and management department shall inform the applicant and the interested party of the right to request a hearing before making the administrative licensing decision.

Article 61 the medical device for the treatment of rare diseases, serious life-threatening diseases and no effective treatment means and respond to public health events and other urgent needs, the drug supervision and management department can make a conditional approval decision, and in the medical device registration certificate contains the expiration date, the need to continue to complete the research work after the market and the completion time frame and other related matters.

Article 62 for the conditional approval of medical devices, the registrant shall collect data related to benefits and risks after the medical device is marketed, continuously monitor and assess the benefits and risks of the product, take effective measures to actively control risks, and complete the study and submit relevant information within the specified period in accordance with the requirements.

Article 63 for the conditional approval of medical devices, the registrant is overdue to complete the study in accordance with the requirements or can not prove that the benefits outweigh the risks, the registrant shall promptly apply for cancellation of medical device registration certificate procedures, drug supervision and management departments may cancel the medical device registration certificate in accordance with law.

Article 64 for the newly developed medical devices not yet included in the classification list, the applicant can directly apply for registration of the third class medical device products, but also based on the classification rules to determine the product category and apply to the State Drug Administration to confirm the category, apply for product registration or product record.

Directly apply for registration of Class III medical devices, the State Drug Administration in accordance with the degree of risk to determine the category. Domestic medical devices identified as Class II or Class I, the applicant should be informed to apply for registration or for filing with the appropriate drug regulatory authority.

Article 65 has been registered medical devices, its management category from the high category adjusted to a lower category, the medical device registration certificate continues to be valid during the validity period. The expiration of the validity period needs to be renewed, should be in the medical device registration certificate expires six months before, in accordance with the adjusted category to the corresponding drug supervision and management department to apply for renewal of registration or for the record.

Medical device management category from a low category to adjust to a high category, the registrant shall apply for registration in accordance with the changed category to the appropriate drug regulatory authority. State Drug Administration in the management category adjustment notice should be made to complete the adjustment of the time limit.

Article 66 of the 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.

Where disputes over patent rights arise during the examination process of the registration application and after its approval, they shall be dealt with in accordance with the provisions of relevant laws and regulations.

Special registration procedures

Section I. Innovative product registration procedures

Applicants for medical devices that meet the following requirements may apply for the application of the innovative product registration procedure under Article 68.

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

(b) The applicant has completed preliminary research on the product and has a basic finalized product, the research process is authentic and controlled, and the research data are 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 at the international leading level in terms of technology, and has significant clinical application value.

Article 69 application for the application of innovative product registration procedures, the applicant should be in the product is basically finalized, the State Drug Administration to submit an application for review of innovative medical devices. The State Drug Administration to organize experts to review, meet the requirements, into the innovative product registration procedures.

Article 70 for the application of innovative product registration procedures for medical device registration applications, the State Drug Administration, as well as to undertake the relevant technical work of the institutions, according to their respective responsibilities to designate a person responsible for timely communication, to provide guidance.

For medical devices included in the registration process of innovative products, the Device Review Center of the National Bureau can communicate with the applicant before the acceptance of the registration application and during the technical review process on major technical issues in the development of the product, major safety issues, clinical trial protocols, summary and evaluation of the results of the phase clinical trials, etc.

Seventy-one into the innovative product registration process of medical devices, 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 to terminate the relevant products and inform the applicant of the innovative product registration process.

Article 72 for the medical device included in the innovative product registration procedure, the applicant does not apply for registration within the specified period, the innovative product registration procedure shall no longer apply.

Section II. Priority registration procedures

Article 73 medical devices meeting one of the following circumstances may apply for the application of priority registration procedures.

(a) Medical devices that diagnose or treat rare diseases or malignant tumours and have obvious clinical advantages, diagnose or treat diseases specific to and prevalent in the elderly and for which no effective diagnostic or therapeutic means are available, are used exclusively for children and have obvious clinical advantages, or are in urgent clinical need and for which no product of the same type has been approved for registration in China.

(b) Medical devices included in national science and technology major special projects or national key research and development programmes.

(c) The State Drug Administration provides for other medical devices that can be subject to priority registration procedures.

Article 74 application for the application of priority registration procedures, the applicant should be in the application for registration of medical devices, the State Drug Administration to apply for priority registration procedures. Belong to the first case of Article 73, the State Drug Administration to organize experts to review, in line with the priority registration procedures; belong to the second case of Article 73, the State Bureau of device review center to review, in line with the priority registration procedures; belong to the third case of Article 73, 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 75 of the priority registration procedures for medical devices into the registration application, the State Drug Administration priority for review and approval, provinces, autonomous regions, municipalities directly under the Central Drug Administration priority arrangements for medical device registration quality management system verification.

In the process of technical review of medical device products included in the priority registration procedure, the National Bureau's device review center shall actively communicate with the applicant in accordance with relevant regulations, and when necessary, special communication can be arranged.

Section III. Emergency registration procedures

Article 76 of the State Drug Administration can be required by law for emergency public health emergencies and there is no similar products listed in China, or although there are similar products listed in China, but the supply of products can not meet the emergency needs of public health emergencies to implement emergency registration of medical devices.

Article 77 application for the application of emergency registration procedures, the applicant shall apply to the State Drug Administration for emergency registration. If the conditions are met, included in the emergency registration procedures.

Article 78 of the implementation of emergency registration of medical device registration applications, the State Drug Administration in accordance with the unified command, early intervention, with the review, scientific approval requirements for processing, parallel medical device product inspection, system verification, technical review and other work.

Chapter V. Change of registration and renewal of registration

Section I. Change of registration

Article 79 The registrant shall take the initiative to conduct post-marketing studies on medical devices to further confirm the safety, effectiveness and quality control of medical devices and strengthen the continuous management of listed medical devices.

Registered Class II and Class III medical device products, their design, raw materials, production processes, scope of application, methods of use and other substantive changes that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for changes in registration procedures; other changes shall be filed with the original registration department within 30 days of the date of change.

The product name, model, specification, structure and composition, scope of application, technical requirements of the product, the address of the manufacturer of the imported medical device, etc., as set forth in the registration certificate, belong to the matters requiring change of registration as stipulated in the preceding paragraph. The name and residence of the registrant, the name and residence of the agent, etc., belong to the matters required to be filed under the preceding paragraph. Domestic medical device production address change, the registrant shall be for the record after the corresponding change in production license.

If other changes occur, the registrant shall do the relevant work in accordance with the requirements of the quality management system and report to the drug regulatory authority in accordance with the regulations.

Article 80 For a change in registration application, the technical review body shall focus on the part of the change for review, and form a review opinion on whether the changed product is safe, effective and of controllable quality.

In the technical review of the application for change of registration, if 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 medical device change registration documents and the original medical device registration certificate combined use, the expiration date of 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 expiration 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 provided for in Article 83 of these Measures, the drug regulatory authority that receives an 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 overdue, the renewal shall be deemed to be granted.

Article 83 shall not be renewed if any of the following applies.

(a) Failure to submit an application for renewal of registration within the prescribed period.

(b) The new mandatory standards for medical devices are released and implemented, and the medical devices applying for renewal of registration cannot meet the new requirements.

(c) The medical device with conditional approval is not completed within the prescribed period of time for the matters contained in the medical device registration certificate.

Article 84 of the renewal of the registration of the approved time in the original registration certificate is valid, the renewal of the registration of the registration card validity start date for the next day of the expiry date of the original registration card; approved time is not in the original registration card validity, the renewal of the registration of the registration card validity start date for the approval of the renewal of the registration date.

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

Chapter VI. Filing of medical devices

Article 86 before the production of Class I medical devices, should be product record.

Article 87 for the filing of medical devices, the filer shall, in accordance with the provisions of the Regulations for the Supervision and Administration of Medical Devices, submit the filing information to the drug regulatory authority to obtain a filing number.

Article 88 has been filed medical devices, the record information table and the record of the product technical requirements change, the filer shall change the record to the original filing department, and submit a description of the changes and related documents. Drug supervision and management department shall post the changes in the record information.

Article 89 has been filed in the medical device management category to adjust to the second or third class medical devices, shall apply for registration in accordance with the provisions of these measures.

Chapter VII. Time frame for work

Article 90 The time limit specified in these measures is the maximum time for the acceptance, technical review, verification and approval of medical device registration. Special registration procedures related to the work time frame, in accordance with the relevant provisions of the special registration procedures.

Professional and technical bodies such as the National Bureau's device review centres should clarify the work procedures and time limits of their units and make them publicly available.

After receiving the application for registration of medical devices and the application for clinical trial, the drug administration department of Article 91 shall forward the application information to the technical review agency within three days from the date of acceptance. The requirements for the acceptance of clinical trial applications shall apply to the provisions of Article 53 of these Measures.

Article 92 The time frame for the technical review of medical device registration shall be implemented in accordance with the following provisions.

(a) The time limit for the technical review of applications for clinical trials of medical devices is 60 days, and the time limit for the technical review of applications after correction of information is 40 days.

(b) The time limit for technical review of applications for registration of class II medical devices, applications for change of registration and applications for renewal of registration is 60 days, and the time limit for technical review of applications after correction of information is 60 days.

(c) The time limit for technical review of applications for registration of Class III medical devices, applications for change of registration and applications for renewal of registration is 90 days, and the time limit for technical review of applications after correction of information is 60 days.

Article 93 The time limit for verification of the quality management system of Class III medical devices within the territory shall be implemented in accordance with the following provisions.

(a) The National Bureau's device review centre shall notify the relevant provincial, autonomous region or municipality directly under the Central Government of the initiation of verification of the medical device registration application within 10 days of its acceptance.

(b) The drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government 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 Review Centre.

Article 94 The drug supervision and administration department receiving the application for registration 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 the decision to approve the registration of medical devices.

Article 96 due to product characteristics and technical review, verification and other work encountered special circumstances do 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 excludes the following from the relevant working time frame.

(i) The time taken by the applicant for additional information, post-verification corrections, etc..

(ii) Delays in verification due to the applicant.

(iii) The timing of external expert consultations, expert consultation meetings and joint reviews with drug review agencies required for pharmaceutical and medical combination products.

(iv) Where the review and approval process has been suspended in accordance with the provisions, the time taken up during the suspension of the review and approval process.

(v) The time taken up by quality management system verification.

The time limits set out in this Article 99 are calculated in working days.

Chapter VIII. Supervision and management

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

One hundred and one State Drug Administration to establish and step-by-step implementation of the unique identification system for medical devices, the applicant, the filer shall submit the unique identification-related information in accordance with the relevant provisions 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 in the provinces, autonomous regions and municipalities directly under the Central Drug Administration. Provinces, autonomous regions and municipalities directly under the Central Drug Administration to the administrative region of the agent organization to carry out daily supervision and management.

Article 103 of the provinces, autonomous regions, municipalities directly under the Central Drug Administration 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 new filings of medical device clinical trial institutions, should be carried out within 60 days after filing supervision and inspection.

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 supervise their continued compliance with the prescribed requirements. The State Drug Administration conducts supervision and inspection of medical device clinical trial institutions as needed.

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

Article 105 to undertake the first class medical device product filing work of the drug supervision and management departments in the post-filing supervision, found that the filing information is not standardized, shall order the filer to correct the deadline.

Article 106 drug supervision and management departments do not timely find the systemic and regional risks of medical device registration and management in the administrative region, or do not timely eliminate the systemic and regional potential problems of medical device registration and management in the administrative region, the higher-level drug supervision and management department may interview the main person in charge of the lower-level drug supervision and management department.

Chapter IX. Legal liability

Article 107 violates the provisions of Article 79 of these Measures and fails to file the occurrence of changes in accordance with the requirements, it shall order rectification within a certain period of time; if it fails to do so, it shall be fined not less than 10,000 yuan but not more than 30,000 yuan.

Article 108 to carry out clinical trials of medical devices do not comply with the clinical trial quality management norms, in accordance with the "supervision and management of medical devices regulations" Article 94 to be punished.

Article 109 The medical device technical review body does not perform its 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 Staff members of departments responsible for the supervision and administration of medicines who violate the provisions, abuse their powers, neglect their duties or engage in favouritism shall be punished in accordance with the law.

Chapter X. Annexes

Article 111 medical device registration or filing unit in principle to the product's technical principles, structural composition, performance indicators and scope of application as the basis for division.

Article 112 The medical device approved for registration refers to the medical device registration certificate and the limited content of the annexes and the medical device produced within the validity of the medical device registration certificate.

Article 113 of the medical device registration certificate in the "structure and composition" column contained in the combination of parts, for the purpose of replacement of consumables, after-sales service, maintenance, etc., for the original registered products, can be sold separately.

Article 114 The applicant in the application for registration of medical device products, change of registration, clinical trial approval can be authorized by the owner of the master file of medical devices, reference to the master file of registered medical devices. The work procedures related to the registration of medical device master file are separately stipulated.

Article 115 medical device registration certificate format by the State Drug Administration unified development.

The registration certificate number is organized as follows.

×1械注 ×2 ××××3 ×4 ×××5 ××××6

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

"国" for domestic Class III medical devices and imported Class II and Class III medical devices.

The abbreviation for the province, autonomous region or municipality directly under the Central Government where the registration and approval department is located for Class II medical devices within the territory.

×2 for the form of registration.

The word "准" applies to medical devices in the territory.

The word "进" applies to imported medical devices.

The word "许" applies to medical devices in Hong Kong, Macao and Taiwan.

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

× 4 for the product product category.

× × 5 is the product classification code.

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

For renewal of registration, the numbers of ××××3 and ××××6 remain unchanged. If the product management category is adjusted, the numbers should be renumbered.

Article 116 The filing number of Class I medical devices shall be arranged in the following manner.

× 1 械备 ××××2 ××××3. where.

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

"国" for imported Class I medical devices.

The first class of medical devices within the territory is the abbreviation of the province, autonomous region or municipality directly under the Central Government where the department of record is located plus the abbreviation of the municipal administrative region where the district is located (in the absence of the corresponding municipal administrative region, only the abbreviation of the province, autonomous region or municipality directly under the Central Government).

××××2 is the year of filing.

××××3 is the record running number.

Article 117 of the 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 118 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 119 provinces, autonomous regions, municipalities directly under the Central Drug Administration can refer to the provisions of Chapter IV of these measures to develop special registration procedures for Class II medical devices within the administrative region, and reported to the State Drug Administration for the record.

Article 120 medical device product registration fee items, fees and charges in accordance with the relevant provisions of the State Council departments in charge of finance and prices.

Article 121 The registration and filing of in vitro diagnostic reagents managed in accordance with medical devices shall be governed by the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents.

Article 122 The relevant provisions of the supervision and management of custom-made medical devices shall be separately formulated by the State Drug Administration.

The relevant provisions of the management of the registration of pharmaceutical and mechanical combination products, the State Drug Administration separately developed.

The relevant provisions of the emergency use of medical devices, by the State Drug Administration in conjunction with the relevant departments to develop separately.

Article 123 The registration and filing of medical devices in Hong Kong, Macao and Taiwan shall be handled with reference to imported medical devices.

Article 124 These Measures shall come into force on October 1, 2021. the "Measures for the Administration of Medical Device Registration" published by the former State Food and Drug Administration Order No. 4 of July 30, 2014 shall be repealed at the same time.