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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II THE ADMINISTRATION OF MEDICAL DEVICES CHAPTER III THE ADMINISTRATION OF PRODUCTION, TRADING AND USE OF MEDICAL DEVICES CHAPTER IV SUPERVISION OVER MEDICAL DEVICES CHAPTER V PENALTY PROVISIONS CHAPTER VI SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. This Regulation is enacted for the purposes of strengthening the supervision and administration of medical devices, ensuring the safety and effectiveness of medical devices and guaranteeing the human health and safety of lives. Article 2. Any entity or individual engaged in the research and development, production, trading, use, or supervision and administration of medical devices shall abide by this Regulation. Article 3. The "medical device" mentioned in this Regulation means any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application, which does not achieve its principal intended action within or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following expected aims: (1) Prevention, diagnosis , monitoring, treatment or alleviation of disease; (2)Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions; (3) Investigation, replacement or modification for anatomy or a physiological process; (4) Control of conception. Article 4. The drug supervision and administration department of the State Council shall be responsible for the supervision and administration of medical devices throughout the country. The drug supervision and administration departments of the local governments at the county level and above shall be responsible for the supervision and administration of medical devices within their respective administrative area. The drug supervision and administration department of the State Council shall coordinate with the comprehensive department of economy of the State Council to implement the national industrial policy on medical devices. Article 5. The state shall administer the medical devices on the basis of classification. Class I medical devices shall refer to those devices whose safety and effectiveness can be ensured through routine administration. Class II medical devices shall refer to those devices whose safety and effectiveness should be controlled. Class III medical devices shall refer to those devices which are implanted into the human body, or used for life support or sustenance, which may pose potential risk to the human body, and the safety and effectiveness of which must be strictly controlled. The classification catalogue for medical devices shall be worked out, adjusted and promulgated by the drug supervision and administration department of the State Council in accordance with classification principles after consulting with the health department of the State Council. Article 6. The medical devices produced and used for the purpose of providing concrete measuring values shall comply with the requirements of the metrology law. The detailed product list shall be formulated and promulgated by the drug supervision and administration department of the State Council jointly with the metrology administrative department of the State Council. CHAPTER II THE ADMINISTRATION OF MEDICAL DEVICES Article 7. The state encourages the research and development of new medical devices. The term "new medical devices" refers to the new products which are not available in the domestic market, or whose safety, effectiveness and product mechanism have not been recognized within China. The clinical trials of new medical devices of Class II and Class III shall, upon approval, be conducted in accordance with the provisions of the drug supervision and administration department under the State Council. The new medical devices that have gone through clinical trials, and have passed experts' evaluation and review organized by the drug supervision and administration department under the State Council, shall be granted a new product certificate after being approved by the drug supervision and administration department of the State Council. Article 8. The state adopts a product registration system for the production of medical devices. The production of Class I medical devices shall be subject to the examination and approval of the drug supervision and administration departments of the people's governments of the districted cities and shall be granted a product registration certificate. The production of Class II medical devices shall be subject to the examination and approval of the drug supervision and administration departments of the drug supervision and administration departments of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government and shall be granted a product registration certificate. The production of Class III medical devices shall be subject to the examination and approval of the drug supervision and administration department of the State Council and shall be granted a product registration certificate. The production of Class II and Class III medical devices shall be subject to clinical verification. Article 9. The drug supervision and administration departments of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the examination and approval of the clinical trials or clinical verifications of Class II medical devices within their respective administrative area. The drug supervision and administration department of the State Council shall be responsible for the examination and approval of the clinical trials or clinical verifications of Class III medical devices. The clinical trials or clinical verifications of a Class III medical device shall be conducted by a medical institution designated by the provincial people's government or above. The medical institution shall comply with the provisions of the drug supervision and administration department of the State Council when conducting clinical trials or clinical verifications. The qualification of a medical institution to conduct clinical trials or clinical verifications shall be accredited by the drug supervision and administration department of the State Council jointly with the health administrative department of the State Council Article10. A medical institution shall, in light of its clinical need, develop medical devices and use them within this entity under the guidance of the practicing doctors. A Class II medical device developed by a medical institution shall be subject to the examination and approval of the drug supervision and administration department of the provincial people's government or above. A Class III medical device developed by a medical institution shall be subject to the examination and approval of the drug supervision and administration department of the State Council. Article 11. For any medical device to be imported to China for the first time, the import entity shall not file an application with the customs office for going through the import formalities until it has provided the instructions, quality standards, inspection methods and other relevant materials of the medical device, samples as well as certification documents issued by the export country (region) on the approval of the production and sale of the medical device, has got the approval on registration in the drug supervision and administration department of the State Council and has obtained an import registration certificate. Article 12. To apply for the registration of a medical device, the applicant shall, in accordance with the provisions of the drug supervision and administration department of the State Council, submit the technical indicators, testing report and other relevant materials. The drug supervision and administration department of the people's government of a districted city shall, within 30 working days after it accepts an application, decide to approve or disapprove the registration. If it makes a decision of disapproval, it shall give the applicant a written explanation. The drug supervision and administration department of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government shall, within 60 days after it accepts an application, decide to approve or disapprove the registration. If it makes a decision of disapproval, it shall give the applicant a written explanation. The drug supervision and administration department of the State Council shall, with 90 days after it accepts an application, decide to approve or disapprove the registration. If it makes a decision of disapproval, it shall give the applicant a written explanation. Article 13. Where any of the items stated in the product registration certificate for a medical device is changed, the holder entity shall, within 30 days after the change, file an application for going through the modification or re-registration formalities. Article 14. The product registration certificate for a medical device shall be valid for 4 years. The holder entity shall, within 6 months prior to the expiration of the valid period of the project registration certificate, apply for re-registration. After the production of a medical device has been stopped for 2 consecutive years or more, the product registration certificate shall be invalidated automatically. Article 15. The production of medical devices shall meet the national standards, or professional standards if there are no relevant national standards. The national standards on medical devices shall be formulated jointly by the standardization administrative department of the State Council jointly with the drug supervision and administration department of the State Council. The professional standards on medical devices shall be formulated by the drug supervision and administration department of the State Council Article 16. The user instructions, labels and packages of medical devices shall satisfy the relevant standards or provisions of the state. Article 17. The serial number of the product registration certificate for a medical device shall be marked on the product itself and the external package according to the provisions of the drug supervision and administration department of the State Council. Article 18. The state implements a re-evaluation and elimination system for medical devices. The concrete measures shall be formulated by the drug supervision and administration department of the State Council in consultation with other related departments of the State Council. CHAPTER III THE ADMINISTRATION OF PRODUCTION, TRADING AND USE OF MEDICAL DEVICES Article 19. An enterprise engaged in manufacturing medical devices shall meet the following conditions: (1)Having professional technicians that can meet the needs of the medical devices manufactured by it; (2)Having production place and environment that can meet the needs of the medical devices manufactured by it; (3)Having production equipment that can meet the needs of the medical devices manufactured by it; and (4)Having a department or personnel and inspection equipment for the quality inspection of the medical devices manufactured by it. Article 20. To establish an enterprise for manufacturing Class I medical devices, the applicant shall go through the archival filing formalities in the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government. To establish an enterprise for manufacturing Class II and III medical devices, the applicant shall be subject to the examination and approval of the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government, and it shall be granted a Permit for the Medical Device Production Enterprise. No business license may be issued by the administrative department for industry and commerce unless the applicant has obtained a Permit for the Medical Device Production Enterprise. A Permit for the Medical Device Production Enterprise shall be valid for 5 years. When its valid period expires, the enterprise shall go through the examination and approval formalities for a new permit. The concrete measures shall be formulated by the drug supervision and administration department of the State Council. Article 21. A medical device manufacturing enterprise shall not produce any medical device until it has obtained a product registration certificate for a medical device. Article 22. The state adopts a mandatory safety accreditation system for certain Class III medical devices. The detailed product list shall be worked out by the drug supervision and administration department of the State Council jointly with the quality and technical supervisory department of the State Council. Article 23. An enterprise engaged in the trading of medical devices shall meet the following conditions: (1)Having a business site and environment that can meet the needs of its trading of medical devices; (2)Having quality inspection personnel that can meet the needs of its trading of medical devices; and (3)Having the capabilities of technical training, maintenance and after-sale services that can meet the needs of its trading of medical devices. Article 24. To establish an enterprise for the trading of Class I medical devices, the applicant shall go through the archival filing formalities in the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government. To establish an enterprise for the trading of Class II and III medical devices, the applicant shall be subject to the examination and approval of the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government, and it shall be granted a Permit for the Medical Device Trading Enterprise. No business license may be issued by the administrative department for industry and commerce unless the applicant has obtained a Permit for the Medical Device Trading Enterprise. A Permit for the Medical Device Trading Enterprise shall be valid for 5 years. When its valid period expires, the enterprise shall go through the examination and approval formalities for a new permit. The concrete measures shall be formulated by the drug supervision and administration department of the State Council. Article 25. The drug supervision and administration department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall, within 30 working days after it accepts an application for a Permit for the Medical Device Production Enterprise or Permit for Medical Device Trading Enterprise, decide whether or not to issue a permit. If it decides not to issue a permit, it shall give the applicant a written explanation. Article 26. The medical device trading enterprises and medical institutions shall purchase up-to-standard medical devices from production enterprises that have obtained a Permit for the Medical Device Production Enterprise or from the trading enterprises that have obtained a Permit for Medical Device Trading Enterprise, and shall verify the product conformity certificates. No medical device trading enterprise may be engaged in the trading of any medical devices that have not been registered, have no product conformity certificate, are beyond the expiry date, have lost effectiveness or are eliminated. No medical institution may use any medical devices that have not been registered, have no product conformity certificate, are beyond the expiry date, have lost effectiveness or are eliminated. Article 27. No medical institution may re-use any medical devices labeled for single use, it shall destroy them after use and establish a record according to the relevant provisions of the state. Article 28. The state shall establish a medical device quality accident reporting system and a medical device quality accident announcement system. The concrete measures shall be formulated by the drug supervision and administration department of the State Council jointly with the health administrative department and family planning administrative department of the State Council. CHAPTER IV SUPERVISION OVER MEDICAL DEVICES Article 29. A drug supervision and administration department of the people's government at the county level or above shall have medical device supervisors, who shall be responsible for the supervising and inspecting the medical device production enterprises, trading enterprises and medical institutions within its administrative area. Where necessary, they may take samples and ask for the relevant materials in accordance with the provisions of the drug supervision and administration department of the State Council. The relevant entities and personnel shall not refuse to offer or shall not conceal the relevant materials. The supervisors shall keep confidential the samples and materials obtained by them. Article 30. The state shall implement a qualification accreditation system for the medical device testing institutions. No testing institution may test the medical devices unless it has been accredited by the drug supervision and administration department of the State Council jointly with the quality and technical supervisory department of the State Council. A medical device testing institution and its personnel shall keep confidential the technical materials of the entities which are tested and shall not be engaged in or participate in the development, production, trading, technical consultancy and other activities relating to the testing of medical devices. Article 31. For any product that has caused any medical device quality accident or has a potential risk to cause any medical device quality accident, the drug supervision and administration department of the people's government at the county level or above may seal up and detain this product as well as the relevant materials. Article 32. If the safety and effectiveness of a medical device can not be ensured, the drug supervision and administration department of the provincial people's government or above shall revoke its product registration certificate. If its product registration certificate is revoked, this medical device shall not be produced, sold or used; those that have been produced or imported shall be disposed of by the drug supervision and administration department of the people's government at the county level or above. Article 33. Where a drug supervision and administration department of the people's government at the level of districted city or above completes the registration of a product by violating this Regulation, it shall be ordered to make corrections within a time limit by the drug supervision and administration department of the State Council. If it fails to make corrections within the time limit, the product registration certificate for the illegally registered medical device may be revoked and an announcement may be published. Article 34. The medical device advertisements shall be subject to the examination and approval of the drug supervision and administration departments of the provincial people's governments or above. Without approval, no medical device advertisement may be published, broadcasted, spread or posted up. The contents of the medical device advertisements shall be based on the user instructions which are approved by the drug supervision and administration department of the State Council, or by the drug supervision and administration departments of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government. CHAPTER V PENALTY PROVISIONS Article 35. Where any enterprise violates this Regulation due to producing any medical devices without product registration certificate, the drug supervision and administration department of the people's government at the county level or above shall order it to stop the production, confiscate the illegally produced products and illegal proceeds, and fine it not less than 3 times but not more than 5 times of the amount of the illegal proceeds if the amount of the illegal proceeds is 10,000 yuan or more. If there is no illegal proceeds, or if the amount of illegal proceeds is less than 10,000 yuan, it shall fine it not less than 10,000 yuan but not more than 30,000 yuan. If the circumstance is serious, the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall revoke its Permit for the Medical Device Production Enterprise. If any crime is constituted, it shall be subject to criminal liabilities. Article 36. Where any enterprise violates this Regulation due to producing any Class II or Class III medical devices without obtaining the Permit for the Medical Device Production Enterprise, the drug supervision and administration department of the people's government at the county level or above shall order it to stop the production, confiscate the illegally produced products and illegal proceeds, and fine it not less than 3 times but not more than 5 times of the amount of the illegal proceeds if the amount of the illegal proceeds is 10,000 yuan or more. If there is no illegal proceeds, or if the amount of illegal proceeds is less than 10,000 yuan, it shall fine it not less than 10,000 yuan but not more than 30,000 yuan. If any crime is constituted, it shall be subject to criminal liabilities. Article 37. Where any enterprise violates this Regulation due to manufacturing any medical devices that do not meet the national standards or professional standards on medical devices, the drug supervision and administration department of the people's government at the county level or above shall give it a warning and order it to stop the production, confiscate the illegally produced products and illegal proceeds, and fine it not less than 2 times but not more than 5 times of the amount of the illegal proceeds if the amount of the illegal proceeds is 5,000 yuan or more. If there is no illegal proceeds, or if the amount of illegal proceeds is less than 5,000 yuan, it shall fine it not less than 5,000 yuan but not more than 20,000 yuan. If the circumstance is severe, the original certificate issuing department shall revoke its product registration certificate. If any crime is constituted, it shall be subject to criminal liabilities. Article 38. Where any enterprise violates this Regulation due to trading of any Class II or Class III medical devices without a Permit for the Medical Device Trading Enterprise, the drug supervision and administration department of the people's government at the county level or above shall order it to stop the trading, confiscate the illegally produced products and illegal proceeds, and fine it not less than 2 times but not more than 5 times of the amount of the illegal proceeds if the amount of the illegal proceeds is 5,000 yuan or more. If there is no illegal proceeds, or if the amount of illegal proceeds is less than 5,000 yuan, it shall fine it not less than 5,000 yuan but not more than 20,000 yuan. If any crime is constituted, it shall be subject to criminal liabilities. Article 39. Where any enterprise violates this Regulation due to trading of any medical devices which have not been registered, have no product conformity certificate, are beyond the expiry date, have lost effectiveness or are eliminated, or due to purchasing any medical devices from an enterprise without a Permit for the Medical Device Production Enterprise or Permit for the Medical Device Trading Enterprise, the drug supervision and administration department of the people's government at the county level or above shall order it to stop the trading, confiscate the illegally traded products and illegal proceeds, and fine it not less than 2 times but not more than 5 times of the amount of the illegal proceeds if the amount of the illegal proceeds is 5,000 yuan or more. If there is no illegal proceeds, or if the amount of illegal proceeds is less than 5,000 yuan, it shall fine it not less than 5,000 yuan but not more than 20,000 yuan. If the circumstance is serious, the original certificate issuing department shall revoke its Permit for the Medical Device Trading Enterprise. If any crime is constituted, it shall be subject to criminal liabilities. Article 40. When going through the formalities for the registration of a medical device, if the applicant violates this Regulation due to obtaining a product registration certificate for a medical device by providing any false certification, documents, materials or samples, or by other deceitful means, the original certificate issuing department shall revoke the product registration certificate, shall not accept its product registration application within 2 years and shall fine it not less than 10,000 yuan but not more than 30,000 yuan. If it has begun to manufacture such medical device, the original certificate issuing organ shall confiscate the illegally produced products and the illegal proceeds, and shall fine it not less than 3 times but not more than 5 times of the amount of the illegal proceeds if the amount of illegal proceeds is 10,000 yuan or more. If there is no illegal proceeds, or if the amount of illegal proceeds is less than 10,000 yuan, it shall fine it not less than 10,000 yuan but not more than 30,000 yuan. If any crime is constituted, it shall be subject to criminal liabilities. Article 41. Anyone who violates the provisions of Article 34 of this Regulation regarding the medical device advertisements shall be punished by the administrative department for industry and commerce in accordance with the relevant laws and regulations. Article 42. Where any medical institution violates this Regulation due to using any medical devices that have not been registered, have no product conformity certificate, are beyond the expiry date, have lost effectiveness or are eliminated, or due to purchasing any medical devices from an enterprise without a Permit for the Medical Device Production Enterprise or Permit for the Medical Device Trading Enterprise, the drug supervision and administration department of the people's government at the county level or above shall order it to make corrections, shall give it a warning, shall confiscate the illegally used products and illegal proceeds, and shall fine it not less than 1 time but not more than 5 times of the amount of the illegal proceeds if the amount of the illegal proceeds is 5,000 yuan or more. If there is no illegal proceeds, or if the amount of illegal proceeds is less than 5,000 yuan, it shall fine it not less than 5,000 yuan but not more than 20,000 yuan. It shall give the person-in-charge and other directly liable persons a disciplinary sanction. If any crime is constituted, it shall be subject to criminal liabilities. Article 43. Where any medical institution violates this Regulation due to repeatedly using any medical device for single use, or failing to destroy any medical device that should have been destroyed, the drug supervision and administration department of the people's government at the county level or above shall order it to make corrections, give a warning and may fine it not less than 5,000 yuan but not more than 30,000 yuan. If the circumstance is serious, it may fine the medical institution not less than 30,000 yuan but not more than 50,000 yuan. It shall give the person-in-charge and other directly liable persons a disciplinary sanction. If any crime is constituted, it shall be subject to criminal liabilities. Article 44. Where any medical institution undertaking the clinical trials and clinical verifications of medical devices violates this Regulation due to providing any false report, the drug supervision and administration department of the provincial people's government or above shall order it to make corrections, give it a warning and may fine it not less than 10,000 yuan but not more than 30,000 yuan. If the circumstance is serious, it shall revoke its qualification of undertaking clinical trials or clinical verifications and shall give a disciplinary sanction to the person-in-charge and other directly liable persons. If any crime is constituted, it shall be subject to criminal liabilities. Article 45. Where any medical device testing institution or any of its employees violates this Regulation due to engaging in or participating in the development, production, trading or technical consultancy, or due to providing any false testing report, the drug supervision and administration department of the provincial people's government or above shall order it to make corrections, give it a warning and fine it not less than 10,000 yuan but not more than 30,000 yuan. If the circumstance is serious, the drug supervision and administration department of the State Council shall revoke its qualification of testing institution and shall give the person-in-charge and other directly liable persons a disciplinary sanction. If any crime is constituted, it shall be subject to criminal liabilities. Article 46. Where a supervisory and administrative functionary of medical devices violates this Regulation due to abusing his power, seeking private benefits or neglecting his duties, and if any crime is constituted, he shall be subject to criminal liabilities. If the violation does not constitute a crime, he shall be given an administrative sanction. CHAPTER VI SUPPLEMENTARY PROVISIONS Article 47. The administrative measures for the non-profit products of medical devices for contraception shall be separately formulated by the drug supervision and administration department of the State Council jointly with the other relevant departments. Article 48. This Regulation shall come into force as of April 1, 2000. |
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