Regulations on the Supervision and Administration of Medical Devices

original regulation in Chinese

The chinese version shall still prevail in actuality.

Medical Device Management Act is coming in a few years. Contact us for original or english draft!

Historic

2024-09 Draft of People's Republic of China Medical Device Management Act

Impact: the law is getting in details and will have the same power as MDR in EU and higer than "Regulations on the Supervision and Administration of Medical Devices"

Analysis and speculation:

-The law takes some years till final version

-11 chapter and 190 articles

-new chapters: chapter 3 R&D, chapter 6 import and export, chapter 7 usage

-Strength of responsibility of legal representative (=chinese agent)

-Legal representative will be stricter qualified by having manufacturing or distribution licence

-Switch of medical device registration certificate possible

-Accelerate of review of clinical study and preference of multi-centre clinical trial

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Chapter 3 Medical Device Production

Article 30 To engage in the production of medical devices, one shall meet the following conditions:

 (1) Have the production site, environmental conditions, production equipment and professional technical personnel suitable for the medical devices produced;

 (2) Have the medical devices capable of producing medical devices Institutions or full-time inspectors and inspection equipment that conduct quality inspections;

 (3) Have a management system to ensure the quality of medical devices;

 (4) Have after-sales service capabilities that are compatible with the manufactured medical devices;

 (5) Comply with product development and production processes The requirements specified in the document.

Article 31 Those engaged in the production of Class I medical devices shall file with the department responsible for drug supervision and administration of the municipal peoples government at the districted level, and complete the filing after submitting the relevant materials that meet the conditions specified in Article 30 of these regulations. .

 If the medical device record holder produces the I class medical device by himself, he may submit the relevant materials that meet the conditions specified in Article 30 of these Regulations at the time of product filing in accordance with Article 15 of these Regulations to complete the production record.

Article 32 Those engaged in the production of Class II and Class III medical devices shall apply to the drug regulatory authority of the local province, autonomous region, or municipality directly under the Central Government for a production license and submit relevant materials that meet the conditions specified in Article 30 of these Regulations. And the registration certificate of the medical device produced.

Production license application for acceptance of drug regulatory department shall review information on the application, verification as required by drug regulatory department of the State Council of Medical Devices regulate the production and quality management, and the date of acceptance of the application within 20 working days in the decision. For those that meet the prescribed conditions, the license is granted and a medical device production license is issued; for those that do not meet the prescribed conditions, the license is not granted and the reasons are stated in writing. The medical device production license is valid for 5 years. If the validity period expires and needs to be renewed, the renewal procedures shall be handled in accordance with the legal provisions of the relevant administrative license.　

Article 33 The medical device production quality management norms shall address matters that affect the safety and effectiveness of medical devices, such as the design and development of medical devices, production equipment conditions, raw material procurement, production process control, product release, and enterprise organization and staffing.

Article 34 The medical device registrant and record holder can produce medical devices on their own, or they can entrust enterprises that meet the requirements of these regulations and have corresponding conditions to produce medical devices.

In the case of entrusted production of medical devices, the medical device registrant and record holders shall be responsible for the quality of the entrusted production of medical devices, and strengthen the management of the production activities of the entrusted production enterprises to ensure that they are produced in accordance with statutory requirements. The medical device registrant and record holder shall sign a commission agreement with the entrusted manufacturing enterprise to clarify the rights, obligations and responsibilities of both parties. The entrusted production enterprise shall organize production in accordance with laws and regulations, medical device production quality management norms, mandatory standards, product technical requirements and entrusted agreements, be responsible for the production activities, and accept the supervision of the entrusting party.

Implantable medical devices with high risks shall not be commissioned for production, and the specific catalogue shall be formulated, adjusted and announced by the drug regulatory department of the State Council.

Article 35 Medical device registrants, record holders and entrusted manufacturers shall establish and improve a quality management system compatible with the medical devices produced and ensure their effective operation in accordance with the medical device production quality management regulations; strictly follow the registered or record. The technical requirements of the products are organized to ensure that the medical devices that leave the factory meet the mandatory standards and the technical requirements of the registered or filed products.

Medical device registrants, record holders and entrusted manufacturers shall conduct self-inspection on the operation of the quality management system on a regular basis, and submit annual self-testing reports in accordance with the regulations of the drug regulatory authority under the State Council.

Article 36 If the production conditions of medical devices change and no longer meet the requirements of the medical device quality management system, the medical device registrant, record holder and entrusted manufacturer shall immediately take corrective measures; if it may affect the safety and effectiveness of the medical device, The production activities shall be stopped immediately and a report shall be made to the original production license or production filing department.

Article 37 Medical devices should use generic names. The generic name shall comply with the medical device naming rules formulated by the drug regulatory authority under the State Council.

Article 38 The State shall implement the unique identification system of medical devices step by step according to the category of medical device to realize the traceability of medical devices. The specific measures shall be formulated by the drug regulatory department of the State Council in conjunction with relevant departments of the State Council.

Article 39 Medical devices shall have instructions for use and labels. The contents of the instructions and labels shall be consistent with the relevant contents registered or filed to ensure authenticity and accuracy.

The instructions and labels of medical devices should indicate the following items:

(1) Product generic name, model, and specifications

(2) Name, address and contact information of the medical device registrant, record holder or entrusted manufacturer

(3) Production date, use period or expiration date

(4) Product performance, main structure and scope of application

(5) Taboos, precautions and other warnings or reminders

(6) Installation and use instructions or diagrams

(7) Maintenance methods, special transportation, storage conditions and methods

(8) Technical requirements and other content should be marked

The class II and III medical devices should also be marked with the number of the medical device registration certificate. Medical devices used by consumers themselves should also have special instructions for safe use.

Chapter 5 Handling of Adverse Events and Recall of Medical Devices

Article 61 The State Council establishes a medical device adverse event monitoring system to collect, analyze, evaluate and control medical device adverse events in a timely manner.

Article 62 Medical device registrants and record holders shall establish a medical device adverse event monitoring system, be equipped with adverse event monitoring institutions and personnel suitable for their products, actively carry out adverse event monitoring for their products, and follow the guidelines of the drug regulatory authority under the State Council. According to the regulations, report investigation, analysis, evaluation, product risk control, etc. to the medical device adverse event monitoring technical agency.

Medical device manufacturers and users shall assist medical device registrants and record holders in monitoring the adverse events of the medical devices produced, operated or used; discovering medical device adverse events or suspicious adverse events shall comply with the regulations of the State Council’s drug regulatory authority , To report to the technical agency for medical device adverse event monitoring.

Other units and individuals who discover medical device adverse events or suspicious adverse events have the right to report to the department in charge of drug supervision and management or medical device adverse event monitoring technical institutions.

Article 63 The drug regulatory department of the State Council shall strengthen the construction of a medical device adverse event monitoring information network.

Medical device adverse event monitoring technical institutions should strengthen the monitoring of medical device adverse event information, and actively collect information on adverse events; if adverse events are discovered or received, they should be verified in a timely manner, and investigation, analysis, and evaluation should be carried out when necessary, and they should be reported to the responsible drug Supervision and management departments and health authorities report and put forward suggestions for handling.

Medical device adverse event monitoring technical institutions shall publish contact information to facilitate medical device registrants, record holders, production and operation enterprises, users, etc. to report medical device adverse events.

Article 64 The department responsible for drug supervision and administration shall promptly take control measures such as issuing warning information and ordering the suspension of production, import, operation and use based on the assessment results of adverse events of medical devices.

The drug supervision and administration department of the people's government at or above the provincial level shall, in conjunction with the health authorities at the same level and relevant departments, organize timely investigation and treatment of medical device adverse events that cause sudden, mass injuries or deaths, and organize strengthened monitoring of similar medical devices .

The department in charge of drug supervision and management shall promptly notify the health authority at the same level of the adverse event monitoring of the medical device user unit.

Article 65 Medical device registrants, record holders, manufacturing and operating enterprises, and user units shall cooperate with medical device adverse event monitoring technical institutions, drug supervision and management departments, and health authorities in the investigation of medical device adverse events.

Article 66 In any of the following circumstances, the medical device registrant and record holder shall take the initiative to carry out the re-evaluation of the medical device that has been marketed:

(1) According to the development of scientific research, there is a change in the understanding of the safety and effectiveness of the medical device;

(2) Medical device adverse event monitoring, evaluation results show that medical devices may be defective;

(3) Drug regulatory department of the State Council, under other circumstances.

The medical device registrant and record holder shall, based on the results of the re-evaluation, take corresponding control measures to improve the medical devices already on the market, and make registration changes or record changes in accordance with regulations. If the result of the re-evaluation shows that the safety and effectiveness of the medical device on the market cannot be guaranteed, the medical device registrant and record holder shall take the initiative to apply for cancellation of the medical device registration certificate or cancellation of the record; the medical device registrant or record holder has not applied for the cancellation or cancellation of the medical device registration certificate In case of filing, the medical device registration certificate shall be cancelled or the filing shall be cancelled by the department responsible for drug supervision and administration.

The drug supervision and administration department of the people's government at or above the provincial level shall conduct re-evaluation of medical devices that have been marketed based on the monitoring and evaluation of medical device adverse events. If the result of the re-evaluation shows that the safety and effectiveness of the medical device on the market cannot be guaranteed, the medical device registration certificate shall be cancelled or the filing shall be cancelled.

The department responsible for drug supervision and administration shall promptly announce the cancellation of the medical device registration certificate and the cancellation of the record to the public. Medical devices whose registration certificates for medical devices have been cancelled or whose filings have been cancelled shall not continue to be produced, imported, operated, or used.

Article 67 If the medical device registrant or record holder discovers that the medical device produced does not meet the mandatory standards, the technical requirements of the registered or filed product, or has other defects, it shall immediately stop production and notify the relevant operating enterprise and user unit Stop business and use with consumers, recall medical devices that have been on the market, take measures such as remediation and destruction, record relevant conditions, release relevant information, and report the recall and handling of medical devices to the department responsible for drug supervision and management and the health authority report.

If the entrusted production or operation enterprise of medical devices discovers that the production or operation of the medical device is under the conditions specified in the preceding paragraph, it shall immediately stop the production and operation, notify the medical device registrant and record holder, and record the suspension of production, operation and notification. The medical device registrant and record holder believe that the medical device that needs to be recalled in accordance with the provisions of the preceding paragraph shall be recalled immediately.

If the medical device registrant, record holder, entrusted manufacturing enterprise, or operating enterprise fails to implement the recall or stop production or operation in accordance with the provisions of this article, the department responsible for drug supervision and administration may order the recall or stop production or operation.

Chapter 6 Supervision and Inspection

Article 68 The State establishes a system of professional and specialized inspectors to strengthen the supervision and inspection of medical devices.

Article 69 The department responsible for drug supervision and management shall strengthen the supervision and inspection of the quality of medical devices in the development, production, operation and use of medical devices, and conduct key supervision and inspections on the following items:

(1) Whether it is in accordance with the registered or the technical requirements of the registered products are to organize production;

(2) Whether the quality management system maintains effective operation;

(3) Whether the production and operation conditions continue to meet the statutory requirements.

When necessary, the department responsible for drug supervision and administration may conduct extended inspections of other relevant units and individuals that provide products or services for medical device development, production, operation, and use.

Article 70 The department in charge of drug supervision and management has the following powers in supervision and inspection:

 (1) Entering the site to conduct inspections and taking samples;

 (2) Inquiring, copying, sealing up, and seizing relevant contracts, bills, account books and other relevant materials;

 (3) Seal up and seize medical devices that do not meet statutory requirements, illegally used spare parts, raw materials, and tools and equipment used in the illegal production and operation of medical devices;

 (4) Seal up places that violate the provisions of these regulations and engage in medical device production and operation activitie.

In conducting supervision and inspection, law enforcement certificates shall be presented to keep the business secrets of the entity under inspection.

Relevant units and individuals shall cooperate in supervision and inspection, provide relevant documents and materials, and shall not conceal, refuse, or obstruct.

Article 71 The competent health department shall strengthen supervision and inspection of the use of medical devices by medical institutions. When implementing supervision and inspection, you can enter a medical institution to consult and copy relevant files, records and other relevant materials.

Article 72 Where there are hidden product quality and safety hazards in the production and operation of medical devices, and if no timely measures are taken to eliminate them, the department responsible for drug supervision and administration may take measures such as warnings, responsibility interviews, and orders for rectification within a time limit.

For medical devices that cause harm to the human body or that there is evidence to prove that they may harm human health, the department responsible for drug supervision and administration may take emergency control measures that order the suspension of production, import, operation, and use, and issue safety warning information.

Article 73 The department responsible for drug supervision and administration shall strengthen the random inspection and inspection of medical devices produced, operated and used by medical device registrants, record holders, production and operation enterprises and users. Random inspections shall not charge inspection fees and any other expenses, and the required expenses shall be included in the budget of the government at the same level. The drug supervision and administration department of the people's government at or above the provincial level shall issue a medical device quality announcement in a timely manner based on the conclusions of random inspections.

The competent health department shall supervise and evaluate the use of large-scale medical device; if any illegal use and excessive inspection and over-treatment related to large-scale medical device are found, it shall be corrected immediately and dealt with in accordance with the law.

Article 74 If the department responsible for drug supervision and management fails to discover the systemic risks of medical device safety in time, and fails to eliminate the hidden dangers of medical device safety in the supervision and management area in time, the people's government at the same level or the department in charge of the drug supervision and management of the people's government at a higher level shall deal with it. The main person in charge conducts an interview.

Where the local people's government fails to perform its medical device safety responsibilities and fails to eliminate major regional medical device safety hazards in a timely manner, the higher-level people's government or the drug supervision and administration department of the higher-level people's government shall hold an interview with its main person in charge.

The department and the local people's government interviewed shall take immediate measures to rectify and reform the supervision and management of medical devices.

Article 75 The qualification accreditation of medical device inspection institutions shall be managed in a unified manner in accordance with relevant national regulations. Only the inspection agency recognized by the certification and accreditation supervision and management department of the State Council and the drug regulatory department of the State Council can carry out inspections on medical devices.

If the department in charge of drug supervision and administration needs to inspect medical devices in law enforcement work, it shall entrust a qualified medical device inspection agency to conduct the inspection and pay the relevant expenses.

If the parties have objections to the inspection conclusions, they may submit an application for re-inspection to the department that conducts sampling inspection or the department responsible for drug supervision and administration at the next higher level within 7 working days from the date of receipt of the inspection conclusion, and the department that accepts the re-inspection application The re-inspection agency is randomly selected in the list of re-inspection agencies to conduct re-inspection. The medical device inspection agency undertaking the re-inspection work shall make a re-inspection conclusion within the time specified by the drug regulatory authority under the State Council. The re-inspection conclusion is the final inspection conclusion. The re-inspection institution and the initial inspection institution shall not be the same institution; if there is only one qualified inspection institution for the relevant inspection items, the undertaking department or personnel shall be changed during the re-inspection. The list of re-inspection agencies shall be announced by the drug regulatory department of the State Council.

Article 76 For medical devices that may contain harmful substances or change the design, raw materials and production processes of medical devices without authorization and have hidden safety hazards, medical devices that cannot be inspected in accordance with the inspection items and inspection methods specified in the national standards and industry standards for medical devices The inspection agency may use the supplementary inspection items and inspection methods approved by the drug regulatory authority of the State Council to conduct inspections; the inspection conclusions drawn from the supplementary inspection items and inspection methods may be used as the basis for the quality of medical devices recognized by the drug regulatory authority.

Article 77 The market supervision and management department shall supervise and inspect medical device advertisements in accordance with relevant advertising management laws and administrative regulations, and investigate and deal with illegal acts.

Article 78 The department responsible for drug supervision and administration shall, through the online government service platform of the drug supervision and administration department of the State Council, promptly publish the daily supervision and management information of medical device licensing, filing, random inspection, investigation of illegal acts, etc. in accordance with the law. However, the commercial secrets of the parties concerned shall not be disclosed.

The department in charge of drug supervision and management establishes the credit files of medical device registrants, record holders, production and operation enterprises, and users, increases the frequency of supervision and inspection for those with bad credit records, and strengthens punishment for untrustworthiness according to law.

Article 79 The department responsible for drug supervision and administration and other departments shall publish the contact information of the unit, and accept consultation, complaint, and report. The department in charge of drug supervision and management and other departments shall respond in time when receiving inquiries related to the supervision and management of medical devices; when receiving complaints and reports, they shall verify, handle and respond in a timely manner. The consultations, complaints, and reports, as well as their responses, verifications, and handling, shall be recorded and kept.

If a report on medical device development, production, operation, and use is true after investigation, the department responsible for drug supervision and administration and other departments shall reward the reporter. Relevant departments shall keep the reporter confidential.

Article 80 The drug regulatory department of the State Council formulates, adjusts, and revises the catalogues and regulations related to the supervision and management of medical devices, and shall solicit public opinions; take the form of hearings, demonstration meetings, etc., to listen to experts and medical device registrants, The opinions of the filing person, production and operation enterprises, user units, consumers, industry associations and related organizations.

Chapter 7 Legal Liability

Article 81 Under any of the following circumstances, the department responsible for drug supervision and administration shall confiscate illegal income, illegal production and operation of medical devices, and tools, equipment, raw materials and other items used in illegal production and operation; illegal production and operation of medical devices value of the amount is less than 1 k, and impose a 50 k to 150 k yuan fine; the value of the amount of 10k yuan, and impose value of the amount 15 times more than 30 times the fine; the circumstances are serious, ordered to cease , Within 10 years, the relevant responsible persons and units will not accept medical device license applications, and the legal representatives, main responsible persons, directly responsible persons in charge and other responsible persons of the illegal units will be confiscated from the unit’s income during the occurrence of the illegal acts. , And impose a fine of more than 30% of income but not more than 3 times, and prohibit them from engaging in medical device production and operation activities for life:

(1) Production and operation of Class II and Class III medical devices that have not obtained a medical device registration certificate

(2) Engaging in the production activities of the second and third categories of medical devices without permission

(3) Engaging in the business activities of the third categories of medical devices without permission.

 In the case of the first item of the preceding paragraph and the circumstances are serious, the original license-issuing department shall revoke the medical device production license or medical device business license.

Article 82 Anyone who disposes and uses large-scale medical device without permission shall be ordered by the health authority of the peoples government at or above the county level to stop the use, give a warning, and confiscate the illegal income; if the illegal income is less than 10k yuan, a penalty of more than 50k to 100 k yuan shall be imposed.  the illegal gains 10k yuan or more yuan, and impose illegal income 10 times more than 30 times the fine; the circumstances are serious, 5 large medical device configuration permit application will not be accepted during the year related to liability and the units proposed for illegal The legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% but not more than 3 times of the income, and shall be punished in accordance with the law.

Article 83 Where false information is provided or other deceptive methods are used when applying for an administrative license for medical devices, the administrative license shall not be granted. If the administrative license has been obtained, the administrative license shall be revoked by the department that made the administrative license decision, and the illegal income and illegal production shall be confiscated. For medical devices used in business, applications for medical device licenses submitted by relevant persons and units will not be accepted within 10 years; medical devices used in illegal production and operation with a value of less than 10,000 yuan will be fined between 50k yuan and 150k yuan; the value of the amount of 1 million yuan, and impose value of the amount 15 times more than 30 times the fine; executives circumstances are serious, ordered to cease, the legal representative of the illegal units, the main person in charge, directly in charge and other responsibilities Personnel, confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% of the income but not more than 3 times, and prohibit them from engaging in medical device production and operation activities for life.

 Anyone who forges, alters, sells, rents, or lends relevant medical device licenses shall be confiscated or revoked by the original license-issuing department, and the illegal gains shall be confiscated; if the illegal gains are less than 10,000 yuan, a fine of 50k yuan up to 100k yuan shall be imposed. ; illegal income 10k yuan, and impose illegal income 10 times more than 20 times the fine;, shall constitute a violation of the security Administration punishment public security administration by the public security organs according to law.

Article 84 In any of the following circumstances, the department responsible for drug supervision and management shall announce the name of the unit and product to the public and order it to make corrections within a time limit; if the correction is not made within the time limit, the illegal income and medical devices produced and operated illegally shall be confiscated; illegal production and operation medical devices value of the amount is less than 1k, and impose 1k or above 5k fine; the amount of the value of 1 or more million yuan, impose a value of the amount 5 times more than 20 times the fine; the circumstances are serious, The legal representative, main person in charge, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 2 times the income . Prohibited within 5 years it is engaged in the production and operation of medical devices:

(1) Production and operation of the first-class medical devices that have not been registered

(2) The production of I class medical devices without the registration

(3) The operation of the II class medical devices without registration

(4) The files that have been filed do not meet the requirements

Article 85 If false information is provided during filing, the department responsible for drug supervision and management shall announce the name of the filing unit and product to the public, and confiscate illegal income and illegally produced and operated medical devices; the value of illegally produced and operated medical devices is less than 1k, and impose 20k to 50k fine; the value of the amount of 10k yuan or more, the value of the amount and impose a 5 times more than 20 times the fine; the circumstances are serious, ordered to cease, on illegal units The legal representative, the main person in charge, the directly responsible person in charge and other responsible persons shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 3 times the income, and prohibit them from engaging in medical device for 10 years Production and business activities.

Article 86 In any of the following circumstances, the department responsible for drug supervision and administration shall order corrections and confiscate the medical devices used in illegal production and operation; if the value of the medical devices used in illegal production and operation is less than 10k yuan, they shall be punished 20k yuan to 50k yuan fine; the value of the amount of 1 million or more, the value of the amount and impose a 5 times more than 20 times the fine; the circumstances are serious, ordered to cease until the original issuing authority shall revoke the registration certificate of medical devices , Medical device production license, medical device business license, the legal representative, main person in charge, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income obtained from the unit during the period of the illegal act and the premises Receive a fine of more than 30% of income but not more than 3 times, and prohibit them from engaging in medical device production and operation activities within 10 years:

 (1) The production, operation, and use of medical devices that do not meet mandatory standards or do not meet the technical requirements of registered or filed products

 (2) Failure to organize production in accordance with the registered or filed product technical requirements, or failure to establish a quality management system and maintain effective operation in accordance with the provisions of these regulations, which affects product safety and effectiveness

 (3) Operation and use without conformity certification documents, expired, or invalid, Obsolete medical devices, or use medical devices that have not been registered according to law

 (4) Refusing to be recalled after being ordered by the department responsible for drug supervision and administration, or ordered to stop or suspend production, import, and operation by the department responsible for drug supervision and administration After that, it still refuses to stop the production, import, and operation of medical devices

 (5) Entrusting enterprises that do not meet the requirements of these regulations to produce medical devices, or failing to manage the production activities of the entrusted manufacturing enterprises

 (6) Import of expired, invalid or eliminated medical device

Article 87 Medical device operating enterprises and user units have fulfilled the obligations of purchase inspection and other obligations stipulated in these Regulations, and have sufficient evidence to prove that they do not know that the medical devices they operate and use are the first paragraph of Article 81 of the Regulations. If the medical devices under the conditions specified in paragraph 1 of Article 84, paragraph 1 of Article 86, and paragraph 3 of Article 86, and the source of their purchase can be truthfully stated, the medical devices that they operate and use that do not meet the statutory requirements shall be confiscated Devices can be exempted from administrative penalties.

Article 88 of the following circumstances shall be ordered by the drug regulatory department responsible for corrections and 10k or above 50k yuan fine; refuse to correct, at 50k to 100k yuan fine; circumstances In serious cases, it shall be ordered to suspend production and business until the original license-issuing department revokes the medical device production license and medical device business license. The legal representative, main responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be confiscated. During the period of the act, the income received from the unit, and the penalty is more than 30% or less than 2 times the income and it is prohibited from engaging in medical device production and operation activities within 5 years:

 (1) The production conditions change and the medical device quality management system is no longer in compliance Requirement, failure to rectify, stop production, and report in accordance with these regulations

 (2) Production and operation manuals and labels of medical devices that do not meet the requirements of these regulations

 (3) Fail to transport and store medical devices in accordance with the requirements of medical device manuals and labelling

 (4) Transfer of medical devices in use that have expired, expired, eliminated or failed inspections

Article 89 of the following circumstances, and in accordance with their respective responsibilities shall be ordered to correct by the department responsible for drug administration and health authorities, given a warning; refuse to correct, at 10k to 100 k yuan fine; serious cases If the company is involved, it shall be ordered to suspend production and business until the medical device registration certificate, medical device production license, and medical device business license are revoked by the original issuing authority, and the legal representative, main person in charge, directly responsible person in charge and other responsibilities of the illegal entity staff at the 1k or above 3k fine:

(1) Self-testing reports not submitted in accordance with the requirements of the quality management system

(2) Not have the legal qualification of the purchase of medical device

(3) Medical device enterprises or user has not established and implemented the medical device purchase inspection record system in accordance with the regulations

(4) Operating enterprises engaged in the second and third category medical device wholesale business and the third category medical device retail business have not established in accordance with the regulations and implement the sales record system

(5) Medical device registrants, record holders, production and operation enterprises, and user units fail to carry out medical device adverse event monitoring in accordance with the provisions of these regulations, fail to report adverse events in accordance with requirements, or monitor technology for medical device adverse events Adverse event investigations carried out by institutions, departments responsible for drug supervision and management, and health authorities will not cooperate

(6) Medical device registrants and record holders fail to formulate post-marketing research and risk control plans in accordance with regulations and ensure effective implementation

(7) Medical device registrants and record holders fail to establish and implement a product traceability system in accordance with regulations

(8) Medical device registrants, record holders, and operating companies engaged in online medical device sales fail to inform the department responsible for drug supervision and administration in accordance with regulations

(9) Medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance. The user of the medical device does not perform inspection, inspection, calibration, maintenance, maintenance and records in accordance with the requirements of the product manual, and analyzes and evaluates in time to ensure that the medical device is in good condition

(10) The use of medical device units are not properly preserved the original purchase of materials class III medical devices.

Article 90 For following circumstances shall a warning be given by the people's governments above the county level health authority: refuse to correct, at 50k to 100k yuan fine; circumstances are serious, at 10 k to 30k yuan or less, the relevant medical device use activities shall be suspended until the original license issuing department revokes the practice license, and the relevant responsible personnel shall be ordered to suspend the practice activities for more than 6 months and less than 1 year until the original license issuing department revokes the relevant activities. Personnel practice certificate, the legal representative, main person in charge, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 3 times the income and give sanctions in accordance with the law:

 (1) For reused medical devices, the medical device user fails to dispose of them in accordance with the disinfection and management regulations

 (2) The medical device user reuses single-use medical devices or fails to destroy them in accordance with regulations used single-use medical devices

 (3) The medical device user fails to record information on large medical devices and implantable and interventional medical devices in relevant records such as medical records in accordance with regulations

 (4) The medical device user discovers that medical devices used have potential safety hazards. Users fail to notify for maintenance, or continue to use medical devices that cannot meet the safety standards after maintenance

 (5) Medical device users use large-scale medical device in violation of regulations and cannot guarantee medical quality and safety

Article 91 Imported medical devices in violation of relevant laws and administrative regulations on the inspection of import and export commodities shall be dealt with in accordance with the law by the entry-exit inspection and quarantine agency.

Article 92 Operators of e-commerce platforms that provide services for medical device online transactions violate the provisions of these Regulations by failing to perform real-name registration of online medical device operators, review licensing, registration, and filing conditions, stop and report illegal acts, and stop Those who provide management obligations such as online trading platform services shall be punished by the department responsible for drug supervision and management in accordance with the provisions of the "E-commerce Law of the People's Republic of China".

Article 93 If a clinical trial is carried out without the registration of a medical device clinical trial institution, the department in charge of drug supervision and administration shall order it to stop the clinical trial and make corrections; if it refuses to make corrections, the clinical trial data shall not be used for product registration, filing, and processing. A fine of 50k yuan to 100k yuan shall be fined and an announcement shall be made to the public; if serious consequences are caused, it shall be prohibited from conducting clinical trials of related professional medical devices within 5 years, and a fine of 100k yuan but less than 300k yuan shall be imposed. The legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% but not more than 3 times of the income, and shall be punished in accordance with the law.

If a clinical trial sponsor has carried out a clinical trial without filing, the department responsible for drug supervision and management shall order the suspension of the clinical trial, impose a fine of 50k yuan up to 100k yuan on the clinical trial sponsor, and make an announcement to the public; if serious consequences are caused, Impose a fine of 100k yuan up to 300k yuan. The clinical trial data shall not be used for product registration and filing, and medical device registration applications submitted by relevant responsible persons and units will not be accepted within 5 years.

If a clinical trial sponsor conducts a III class medical device clinical trial with a higher risk to the human body without approval, the department responsible for drug supervision and management shall order the immediate termination of the clinical trial and impose a penalty of 100kyuan to 300k yuan on the clinical trial sponsor The following fines shall be announced to the public; if serious consequences are caused, a fine of 300k yuan up to 1 million yuan shall be imposed. The clinical trial data shall not be used for product registration, and the clinical trial and registration applications for medical devices submitted by relevant responsible persons and units will not be accepted within 10 years. The legal representative, main responsible person, directly responsible person in charge and other responsible persons of the illegal unit will not be accepted. , Confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 3 times the income.

Article 94 If a medical device clinical trial institution conducts a medical device clinical trial that fails to comply with the clinical trial quality management norms, the department in charge of drug supervision and management shall order it to make corrections or immediately stop the clinical trial, and impose a fine of 50k yuan up to 100k yuan; If serious consequences are caused, the relevant professional medical device clinical trials are prohibited within 5 years, and the health authority shall confiscate the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the illegal unit during the period of the illegal act. The income earned by a unit and a fine of more than 30% and less than three times the income received shall be punished in accordance with the law.

Article 95 If a medical device clinical trial institution issues a false report, the department responsible for drug supervision and administration shall impose a fine of 100k yuan up to 300k yuan; if there is illegal income, the illegal income shall be confiscated; it shall be prohibited from conducting relevant professional medical treatment within 10 years Device clinical trials; the health authority shall confiscate the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the illegal unit, and confiscate the income received from the unit during the period of the illegal act, and more than 30% of the income obtained from the premises Fines below 3 times shall be punished according to law.

Article 96 If a medical device inspection agency issues a false testing report, the competent authority granting the qualification will revoke the inspection qualification, and the relevant responsible persons and units will not accept the qualification accreditation application for 10 years, and impose a charge of 100k yuan or more and 300k yuan. The following fines; where there is illegal income, the illegal income shall be confiscated; the legal representative, the main responsible person, the directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income obtained from the unit during the period of the illegal act and dispose of the income obtained A fine of more than 30% of the income but less than 3 times shall be punished in accordance with the law; those who are expelled shall be prohibited from engaging in medical device inspection work for 10 years.

Article 97 Anyone who violates these regulations on the management of medical device advertising shall be punished in accordance with the provisions of the Advertising Law of the Peoples Republic of China.

Article 98 Where a domestic legal person designated by overseas manufacturers fail to perform relevant obligations in accordance with the provisions of these Regulations, the drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government shall order correction, give a warning, and impose a 5 A fine of not less than 10k yuan but not more than 100k yuan; if the circumstances are serious, a fine of 100k yuan but not more than 500k yuan shall be imposed, and the legal representative, main person in charge, directly responsible person in charge and other responsible personnel shall be prohibited from engaging in the production and operation of medical devices within 5 years activity.

If overseas manufacturers refuse to implement the administrative penalty decision made in accordance with these regulations, the import of medical devices shall be prohibited for 10 years.

Article 99 If medical device research and development, production, and operation units and inspection institutions violate these regulations and use personnel who are prohibited from engaging in medical device production and operation activities or inspections, the department in charge of drug supervision and administration shall order corrections and give warnings; If it makes corrections, it shall be ordered to suspend production and business until the license is revoked.

Article 100 If a medical device technical review institution or a medical device adverse event monitoring technical institution fails to perform its duties in accordance with the provisions of these Regulations, causing major errors in the review and monitoring work, the department responsible for drug supervision and administration shall order corrections and report criticisms. A warning shall be given; if serious consequences are caused, the legal representative, the main responsible person, the directly responsible person in charge and other responsible persons of the illegal unit shall be punished according to law.

Article 101 If the staff of the department in charge of drug supervision and management or other relevant departments violates the provisions of these regulations, abuses their power, neglects their duties, or engages in malpractices for personal gain, they shall be punished in accordance with the law.

Article 102 Anyone who violates the provisions of these Regulations and constitutes a crime shall be investigated for criminal responsibility according to law; those who cause personal, property or other damage shall be liable for compensation according to law.

Chapter 8 Supplementary Provisions

Article 103 The meaning of the following terms in these Regulations:



Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the necessary Computer software; its utility is mainly obtained through physical methods, not through pharmacology, immunology or metabolism, or although these methods are involved but only play an auxiliary role; its purpose is: 

(1) Disease diagnosis and prevention, Monitoring, treatment or alleviation

(2) Diagnosis, monitoring, treatment, alleviation or functional compensation of injury

(3) Inspection, replacement, adjustment or support of physiological structure or physiological process

(4) Life support or maintenance 

(5) Pregnancy control 　

(6) Provide information for medical or diagnostic purposes by examining samples from human bodies. 

The medical device registrant and record holder refer to the enterprise or research institution that has obtained the medical device registration certificate or handled the record of medical device. 

Medical device users refer to institutions that use medical devices to provide medical and other technical services to others, including medical institutions, family planning technical service institutions, blood stations, apheresis plasma stations, and rehabilitation assistive device adaptation institutions. 

Large-scale medical device refers to large-scale medical device with complex technology, large capital investment, high operating cost, large impact on medical expenses and included in catalog management. 

Article 104 Fees may be charged for the registration of medical device. The specific charging items and standards shall be respectively formulated by the finance and price authorities of the State Council in accordance with relevant state regulations.

Article 105 The administrative measures for medical devices developed by medical and health institutions in response to public health emergencies shall be formulated by the drug regulatory authority of the State Council in conjunction with the competent health authority of the State Council.

The storage, allocation, and supply of non-profit contraceptive medical devices shall abide by the management measures formulated by the competent health department of the State Council in conjunction with the drug regulatory department of the State Council.

The technical guidelines for medical devices of Chinese medicine shall be formulated by the drug regulatory department of the State Council in conjunction with the traditional Chinese medicine regulatory department of the State Council.

Article 106 The supervision and management of the use of military medical devices shall be implemented in accordance with these Regulations and the relevant provisions of the military.

Article 107 The Ordinance comes into force since 01. 06. 2021.

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