Decree of the State Council of the People's Republic of China
No. 276

The Regulation on the Supervision and Administration of Medical Devices, which was adopted at the 24th executive meeting of the State Council on December 28, 1999, is hereby promulgated and shall come into force as of April 1, 2000.

Premier Zhu Rongji
4 January 2000

Regulations on the Supervision and Administration of Medical Devices

Chapter I General Provisions

Article 1 In order to strengthen the supervision and management of medical devices, ensure the effectiveness of medical devices, and protect human health and life, these regulations are formulated.

Article 2 Units or individuals engaged in the development, production, operation, use, supervision and management of medical devices within the territory of the People's Republic of China shall abide by these regulations.

Article 3 The term "medical devices" as mentioned in these Regulations refers to instruments, equipment, appliances, materials or other articles used alone or in combination in the human body, including required software; its effects on the human body surface and in the body are not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role; its use is intended to achieve the following intended purposes:
(I) the prevention, diagnosis, treatment, monitoring and mitigation of diseases;
(II) the diagnosis, treatment, monitoring, mitigation and compensation of injury or disability;
(III) the study, substitution, and regulation of anatomical or physiological processes;
(IV) pregnancy control.

Article 4 The pharmaceutical supervisory and administrative department of the State Council shall be responsible for the supervision and administration of medical devices throughout the country.
The pharmaceutical supervisory and administrative departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective administrative areas.
The pharmaceutical supervisory and administrative department of the State Council shall cooperate with the comprehensive economic management department of the State Council to implement the national medical device industry policy.

Article 5 The State shall implement classified management of medical devices.
The first category refers to medical devices that are sufficient to ensure their effectiveness through regular management.
The second category refers to medical devices whose effectiveness should be controlled.
The third category refers to medical devices implanted into the human body; used to support and maintain life; potentially dangerous to the human body, and their effectiveness must be strictly controlled.
The classified catalogue of medical devices shall be formulated, adjusted and published by the pharmaceutical supervisory and administrative department of the State Council in consultation with the administrative department of health under the State Council in accordance with the rules for the classification of medical devices.

Article 6 The production and use of medical devices for the purpose of providing specific quantities shall comply with the provisions of the Metrology Law. The specific product catalogue shall be formulated and published by the pharmaceutical supervisory and administrative department under the State Council in conjunction with the metrological administrative department under the State Council.

Chapter II Management of Medical Devices

Article 7 The State encourages the development of new medical devices. New medical device products refer to brand-new varieties that have not yet appeared in the domestic market or whose effectiveness and product mechanism have not been recognized in China.
The clinical trial of new products of Class II and Class III medical devices shall be conducted after approval in accordance with the provisions of the drug regulatory department under the State Council.
New medical device products that have completed clinical trials and passed the expert review organized by the pharmaceutical supervisory and administrative department of the State Council shall be approved by the pharmaceutical supervisory and administrative department of the State Council and issued with new product certificates.

Article 8 The State shall implement a product production registration system for medical devices.
The production of Class I medical devices shall be examined and approved by the drug regulatory department of the people's government of the city divided into districts, and a product production registration certificate shall be issued.
The production of Class II medical devices shall be examined and approved by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, and a product production registration certificate shall be issued.
The production of Class III medical devices shall be examined and approved by the pharmaceutical supervisory and administrative department of the State Council, and a product production registration certificate shall be issued.
The production of Class II and Class III medical devices shall pass clinical verification.

Article 9 The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for examining and approving the clinical trial or clinical verification of Class II medical devices within their respective administrative regions. The pharmaceutical supervisory and administrative department of the State Council shall be responsible for examining and approving the clinical trial or clinical verification of Class III medical devices.
Clinical trial or clinical verification shall be conducted in a medical institution designated by the drug regulatory department of the people's government at or above the provincial level. The clinical trial or clinical verification conducted by a medical institution shall comply with the provisions of the drug regulatory department under the State Council.
The qualifications of medical institutions that conduct clinical trial or clinical verification shall be determined by the drug regulatory department under the State Council in conjunction with the health administrative department under the State Council.

Article 10 Medical institutions may, in accordance with the clinical needs of their units, develop medical devices and use them in their units under the guidance of medical practitioners.
The second category of medical devices developed by medical institutions shall be submitted to the drug regulatory department of the people's government at or above the provincial level for examination and approval; the third category of medical devices developed by medical institutions shall be submitted to the drug regulatory department of the State Council for examination and approval.

Article 11 For medical devices imported for the first time, the importing entity shall provide the instructions, quality standards, inspection methods and other relevant materials and samples of the medical devices, as well as the certification documents approved by the exporting country (region) for production and sales, and the drug supervision and administration department under the State Council After approval and registration, and obtaining the import registration certificate, can apply to the customs for import procedures.

Article 12 To apply for registration of medical devices, technical indicators, test reports and other relevant materials shall be submitted in accordance with the provisions of the drug regulatory department under the State Council.
The drug regulatory department of the people's government at the city level divided into districts shall, within 30 working days from the date of accepting the application, make a decision on whether to grant registration; if registration is not granted, it shall explain the reasons in writing.
The pharmaceutical supervisory and administrative department of the people's government of a province, autonomous region or municipality directly under the Central Government shall, within 60 working days from the date of accepting the application, make a decision on whether to grant registration; if registration is not granted, it shall explain the reasons in writing.
The pharmaceutical supervisory and administrative department under the State Council shall, within 90 working days from the date of accepting the application, make a decision on whether to grant registration; if registration is not granted, it shall explain the reasons in writing.

Article 13 If the contents listed in the registration certificate of medical device products change, the holder shall apply for the change or re-registration within 30 days from the date of the change.

Article 14 The medical device product registration certificate shall be valid for four years. The certificate holder shall apply for re-registration within 6 months before the expiration of the product registration certificate.
If the production has been continuously stopped for more than 2 years, the product production registration certificate shall be invalidated by itself.

Article 15 The production of medical devices shall comply with the national standards for medical devices; if there is no national standard, it shall comply with the medical device industry standards.
The national standards for medical devices shall be formulated by the administrative department in charge of standardization under the State Council in conjunction with the pharmaceutical supervisory and administrative department under the State Council. The industry standards for medical devices shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.

Article 16 The instructions, labels and packages of medical devices shall comply with the relevant national standards or regulations.

Article 17 The number of the product registration certificate shall be marked on medical devices and their outer packages in accordance with the provisions of the drug regulatory department under the State Council.

Article 18 The State implements a system of re-evaluation and elimination of medical devices. The specific measures shall be formulated by the pharmaceutical supervisory and administrative department under the State Council in consultation with the relevant departments under the State Council.

Chapter III Administration of Production, Operation and Use of Medical Devices

Article 19 A medical device manufacturing enterprise shall meet the following conditions:
The (I) has professional and technical personnel suitable for the medical devices it produces;
The (II) has a production site and environment suitable for the medical devices it produces;
The (III) has production equipment suitable for the medical devices it produces;
The (IV) has institutions or personnel and inspection equipment for quality inspection of the medical device products it produces.

Article 20 The establishment of a Class I medical device manufacturing enterprise shall be filed with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
The establishment of the second and third categories of medical device manufacturing enterprises shall be reviewed and approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government, and the "Medical Device Manufacturing Enterprise License" shall be issued. Without the "Medical Device Manufacturing Enterprise License", the administrative department for industry and commerce shall not issue a business license.
The "Medical Device Manufacturing Enterprise License" is valid for 5 years, and the license shall be reviewed and issued at the expiration of the validity period. The specific measures shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.

Article 21 A medical device manufacturer may produce medical devices only after obtaining the registration certificate for the production of medical device products.

Article 22 The State shall implement a compulsory certification system for some Class III medical devices. The specific product catalogue shall be formulated by the pharmaceutical supervisory and administrative department of the State Council in conjunction with the quality and technical supervision department of the State Council.

Article 23 A medical device business enterprise shall meet the following conditions:
The (I) has a business site and environment suitable for the medical devices it operates;
The (II) has quality inspectors suitable for the medical devices it operates;
The (III) has after-sales service capabilities such as technical training and maintenance that are suitable for the medical device products it operates.

Article 24 The establishment of a Class I medical device business enterprise shall be filed with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
The establishment of the second and third categories of medical device business enterprises shall be reviewed and approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government, and the "Medical Device Business Enterprise License" shall be issued. Without the Medical Device Business Enterprise License, the administrative department for industry and commerce shall not issue a business license.
The "Medical Device Business License" is valid for 5 years, and the license shall be reviewed and issued at the expiration of the validity period. The specific measures shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.

Article 25 The drug regulatory department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall, within 30 working days from the date of accepting the application for a license for a medical device manufacturer or business enterprise, make a decision on whether to issue a license; if it does not issue a license, it shall explain the reasons in writing.

Article 26 Medical device operating enterprises and medical institutions shall purchase qualified medical devices from the production enterprises that have obtained the Medical Device Manufacturing Enterprise License or the operating enterprises that have obtained the Medical Device Operating Enterprise License, and verify the product qualification certificate.
A medical device business enterprise shall not deal in unregistered, unqualified, expired, invalid or obsolete medical devices.
Medical institutions shall not use unregistered, no certificate of conformity, expired, invalid or obsolete medical devices.

Article 27 Medical institutions shall not reuse disposable medical devices; if they have been used, they shall be destroyed in accordance with the relevant provisions of the State and recorded.

Article 28 The State shall establish a medical device quality accident reporting system and a medical device quality accident announcement system. The specific measures shall be formulated by the pharmaceutical supervisory and administrative department under the State Council in conjunction with the administrative department of health and the administrative department of family planning under the State Council.

Chapter IV Supervision of Medical Devices

Article 29 The pharmaceutical supervisory and administrative departments of the people's governments at or above the county level shall have medical device supervisors. Medical device supervisors shall supervise and inspect the medical device manufacturing enterprises, business enterprises and medical institutions within their respective administrative areas; when necessary, they may take samples and obtain relevant materials in accordance with the provisions of the drug regulatory department of the State Council, and the relevant units and personnel shall not refuse or conceal them. The supervisor shall have the obligation to keep confidential the samples and data obtained.

Article 30 The State implements a qualification recognition system for medical device testing institutions. The testing institutions recognized by the drug regulatory department of the State Council in conjunction with the quality and technical supervision department of the State Council may carry out testing of medical devices.
Medical device testing institutions and their personnel shall have the obligation to keep confidential the technical data of the tested units, and shall not engage in or participate in the development, production, operation and technical consultation of medical devices related to testing.

Article 31 The drug regulatory department of the local people's government at or above the county level may seal up and detain the products and relevant information that have caused or may cause medical device quality accidents.

Article 32 For medical devices that cannot be guaranteed to be effective, the drug regulatory department of the people's government at or above the provincial level shall revoke its product registration certificate. The medical device whose product registration certificate has been revoked shall not be produced, sold or used. If it has been produced or imported, the drug regulatory department of the local people's government at or above the county level shall be responsible for supervision and handling.

Article 33 If the drug regulatory department of the local people's government at or above the city level divided into districts violates the provisions of these regulations, the drug regulatory department of the State Council shall order it to make corrections within a time limit; if it fails to make corrections within the time limit, it may revoke its illegal registration of medical devices. Product registration certificate and make a public announcement.

Article 34 Medical device advertisements shall be reviewed and approved by the drug regulatory department of the people's government at or above the provincial level; without approval, they shall not be published, broadcast, distributed or posted.
The content of medical device advertisements shall be subject to the instructions approved by the drug regulatory department of the State Council or the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government.

Chapter V Penalties

Article 35 Anyone who violates the provisions of these regulations and produces without obtaining a medical device product production registration certificate shall be ordered by the drug regulatory department of the people's government at or above the county level to stop production, confiscate the illegally produced products and illegal income, and the illegal income is more than 10000 yuan. If there is no illegal income or the illegal income is less than 10000 yuan, a fine of 10000 yuan to 30000 yuan shall be imposed; if the circumstances are serious, the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall revoke its "Medical Device Manufacturing Enterprise License"; if a crime is constituted, criminal responsibility shall be investigated according to law.

Article 36 Anyone who violates the provisions of these regulations and produces Class II and Class III medical devices without obtaining the Medical Device Manufacturing Enterprise License shall be ordered by the drug regulatory department of the people's government at or above the county level to stop production and confiscate the illegally produced products and illegal income. If the illegal income is more than 10000 yuan, a fine of 3 to 5 times the illegal income shall be imposed; if there is no illegal income or the illegal income is less than 10000 yuan, and impose a fine of 10000 yuan to 30000 yuan; If a crime is constituted, criminal responsibility shall be investigated according to law.

Article 37 Whoever, in violation of the provisions of these Regulations, produces medical devices that do not meet the national or industrial standards for medical devices shall be given a warning by the drug regulatory department of the people's government at or above the county level, ordered to stop production, confiscate the illegally produced products and illegal income, and impose a fine of more than 5000 yuan and less than 5 times the illegal income; If there is no illegal income or the illegal income is less than 5000 yuan, and impose a fine of 5000 yuan up to 20000 yuan; If the circumstances are serious, the original license issuing department shall revoke the product production registration certificate; If a crime is constituted, criminal responsibility shall be investigated according to law.

Article 38 Anyone who violates the provisions of these regulations and operates Class II and Class III medical devices without obtaining the Medical Device Business Enterprise License shall be ordered by the drug regulatory department of the people's government at or above the county level to stop the operation and confiscate the illegal products and illegal income. If the illegal income is more than 5000 yuan, a fine of 2 to 5 times the illegal income shall be imposed; if there is no illegal income or the illegal income is less than 5000 yuan, and impose a fine of 5000 yuan to 20000 yuan; If a crime is constituted, criminal responsibility shall be investigated according to law.

Article 39 Whoever, in violation of the provisions of these Regulations, deals in medical devices without product registration certificate, qualification certificate, expiration, invalidation or elimination, or purchases medical devices from enterprises without "Medical Device Manufacturing Enterprise License" or "Medical Device Operating Enterprise License", shall be ordered by the drug regulatory department of the people's government at or above the county level to stop the operation, confiscate the illegal products and illegal income, and the illegal income is more than 5000 yuan, A fine of not less than 2 times but not more than 5 times the illegal income shall also be imposed; if there is no illegal income or the illegal income is less than 5000 yuan, a fine of not less than 5000 yuan but not more than 20000 yuan shall be imposed; if the circumstances are serious, the original license issuing department shall revoke the "medical device business license"; if a crime is constituted, criminal responsibility shall be investigated according to law.

Article 40 In violation of the provisions of these Regulations, when applying for medical device registration, providing false certificates, documents, samples, or taking other deceptive means to defraud the medical device product registration certificate, the original issuing department shall revoke the product registration certificate, within two years The product registration application will not be accepted, and a fine of 10000 yuan up to 30000 yuan will be imposed; for those that have already been produced, the illegally produced products and illegal income will be confiscated, if the illegal income is more than 10000 yuan, a fine of 3 to 5 times the illegal income shall be imposed; if there is no illegal income or the illegal income is less than 10000 yuan, a fine of 10000 yuan to 30000 yuan shall be imposed; if a crime is constituted, criminal responsibility shall be investigated according to law.

Article 41 Violation of the provisions of Article 34 of these regulations on medical device advertising shall be dealt with by the administrative department for industry and commerce in accordance with the relevant laws and regulations of the state.

Article 42 In violation of the provisions of these Regulations, medical institutions use medical devices that have no product registration certificate, no certificate of conformity, expired, invalid, or eliminated, or have no "Medical Device Manufacturing Enterprise License" or "Medical Device Business Enterprise License" If a medical device is purchased by an enterprise, the drug regulatory department of the people's government at or above the county level shall order it to make corrections, give a warning, and confiscate it.
Illegally used products and illegal income, illegal income of 5000 yuan or more, and impose a fine of 2 to 5 times the illegal income; if there is no illegal income or the illegal income is less than 5000 yuan, a fine of 5000 yuan to 20000 yuan shall be imposed; The person in charge and other directly responsible persons shall be given disciplinary sanctions in accordance with the law; if a crime is constituted, criminal responsibility shall be investigated in accordance with the law.

Article 43 If, in violation of the provisions of these Regulations, a medical institution repeatedly uses a disposable medical device, or if it should be destroyed but not destroyed, the drug regulatory department of the people's government at or above the county level shall order it to make corrections, give a warning, and may impose a fine of not less than 5000 yuan but not more than 30000 yuan; if the circumstances are serious, the medical institution may impose a fine of not less than 30000 yuan but not more than 50000 yuan, the person in charge and other persons directly responsible shall be given disciplinary sanctions in accordance with the law; if a crime is constituted, criminal responsibility shall be investigated in accordance with the law.

Article 44 If a medical institution that undertakes clinical trial or clinical verification of medical devices in violation of the provisions of these regulations provides false reports, the drug regulatory department of the people's government at or above the provincial level shall order it to make corrections, give a warning, and may impose a fine of 10000 yuan to 30000 yuan; if the circumstances are serious, the qualification for clinical trial or clinical verification shall be revoked, and the person in charge and other persons directly responsible shall be given disciplinary sanctions according to law, investigate criminal responsibility according to law.

Article 45 If, in violation of the provisions of these regulations, medical device testing institutions and their personnel engage in or participate in the development, production, operation and technical consultation of medical devices related to testing, or issue false testing reports, the drug supervision and administration department of the people's government at or above the provincial level shall order them to make corrections, give them a warning and impose a fine of not less than 10000 yuan but not more than 30000 yuan; if the circumstances are serious, the pharmaceutical supervisory and administrative department under the State Council shall revoke the testing qualification of the testing institution and impose disciplinary sanctions on the person in charge and other persons directly responsible according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.

Article 46 In violation of the provisions of these Regulations, medical device supervisors and administrators abuse their powers, engage in malpractices for personal gain, or neglect their duties, which constitutes a crime, shall be investigated for criminal responsibility according to law; if a crime is not constituted, administrative sanctions shall be imposed according to law.

Chapter VI Supplementary Provisions

Article 47 Measures for the administration of non-profit contraceptive medical devices shall be separately formulated by the drug regulatory department under the State Council in conjunction with the relevant departments under the State Council.

Article 48 These Regulations shall enter into force as of April 1, 2000.