The State Council's decision to amend the "Medical Device Supervision and Administration Regulations"

Order of the State Council of the People's Republic of China

No. 680

The "Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices" is hereby promulgated and shall come into force on the date of promulgation.

Premier Li Keqiang

May 4, 2017

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

The State Council has decided to make the following amendments to the Regulations on the Supervision and Administration of Medical Devices:

I. Amend Article 18 to: "Clinical trials of medical devices shall be conducted in clinical trial institutions that meet the corresponding conditions in accordance with the requirements of the quality management specifications for clinical trials of medical devices, and shall be filed with the food and drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where the clinical trial proposer is located. The food and drug supervision and administration department that accepts the filing of clinical trials shall notify the food and drug supervision and administration department and the health and family planning department of the same level where the clinical trial institution is located of the filing situation.

"Medical device clinical trial institutions shall be subject to filing management. The conditions that medical device clinical trial institutions shall meet, the filing management methods and the quality management specifications for clinical trials shall be formulated and promulgated by the food and drug supervision and administration department of the State Council in conjunction with the health and family planning department of the State Council."

II. Combine the first and second paragraphs of Article 34 into the first paragraph: "Medical device users shall have storage places and conditions that are appropriate to the types and quantities of medical devices in use. Units using medical devices shall strengthen technical training for their staff and use medical devices in accordance with product instructions, technical operation specifications and other requirements. "

Add one paragraph as the second paragraph: "The configuration of large medical equipment by medical device users shall comply with the large medical equipment configuration plan formulated by the health and family planning department of the State Council, be consistent with its functional positioning and clinical service needs, have corresponding technical conditions, supporting facilities and professional and technical personnel with corresponding qualifications and capabilities, and obtain a large medical equipment configuration license approved by the health and family planning department of the people's government at or above the provincial level. "

Add one paragraph as the third paragraph: "The management measures for the configuration of large medical equipment shall be formulated by the health and family planning department of the State Council in conjunction with relevant departments of the State Council. The catalog of large medical equipment shall be proposed by the health and family planning department of the State Council in consultation with relevant departments of the State Council and implemented after approval by the State Council. "

3. Combine the first and second paragraphs of Article 56 as the first paragraph: "Food and drug supervision and administration departments shall strengthen the random inspection and testing of medical devices produced, operated and used by medical device production and operation enterprises and users. Inspection fees and any other fees shall not be charged for random inspection and testing, and the required fees shall be included in the government budget at this level. Food and drug supervision and administration departments of people's governments at or above the provincial level shall promptly issue medical device quality announcements based on the conclusions of random inspection and testing. ”
Add one paragraph as the second paragraph: "The competent health and family planning department shall supervise and evaluate the use of large medical equipment; if any illegal use or excessive examination or treatment related to large medical equipment is found, it shall be corrected immediately and dealt with in accordance with the law."
Four. Article 63 adds one paragraph as the third paragraph: "If large medical equipment is configured and used without permission, the competent health and family planning department of the people's government at or above the county level shall order the cessation of use, give a warning, and confiscate the illegal gains; if the illegal gains are less than 10,000 yuan, a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed; if the illegal gains are more than 10,000 yuan, a fine of not less than 5 times but not more than 10 times the illegal gains shall be imposed; if the circumstances are serious, the application for large medical equipment configuration license submitted by the relevant responsible person and unit shall not be accepted within 5 years. ”
V. Amend the first paragraph of Article 64 to: “If a person provides false information or takes other deceptive means to obtain a medical device registration certificate, medical device production license, medical device business license, large medical equipment configuration license, advertising approval document or other licenses, the original issuing department shall revoke the license that has been obtained, impose a fine of not less than RMB 50,000 and not more than RMB 100,000, and will not accept medical device license applications submitted by relevant responsible persons and units within 5 years. ”
VI. Add one paragraph to Article 66 as the second paragraph: “If a medical device operating enterprise or user unit has fulfilled the obligations of purchase inspection and other obligations stipulated in these Regulations, and has sufficient evidence to prove that it did not know that the medical devices it operated and used were medical devices specified in the first and third items of the preceding paragraph, and can truthfully explain the source of its purchase, it may be exempted from punishment, but the medical devices it operates and uses that do not meet the statutory requirements shall be confiscated in accordance with the law. ”

Seventh, add one item to Article 68 as the ninth item: "(IX) Medical device users use large medical equipment in violation of regulations and cannot ensure medical quality and safety", and change the original ninth item to the tenth item.

Eighth, amend Article 69 to: "If a medical device clinical trial is carried out in violation of the provisions of these Regulations, the food and drug supervision and administration department of the people's government at or above the county level shall order rectification or immediate suspension of the clinical trial, and may impose a fine of no more than 50,000 yuan; if serious consequences are caused, the directly responsible supervisor and other directly responsible personnel shall be demoted, dismissed or expelled in accordance with the law; the institution shall not carry out clinical trials of relevant professional medical devices within 5 years.
"If a medical device clinical trial institution issues a false report, the food and drug supervision and administration department of the people's government at or above the county level shall impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; if there is any illegal income, the illegal income shall be confiscated; the directly responsible supervisor and other directly responsible personnel shall be dismissed or expelled in accordance with the law; the institution shall not conduct clinical trials of relevant professional medical devices within 10 years."

IX. Amend Article 73 to: "Food and drug supervision and administration departments, health and family planning departments and their staff shall strictly follow the types and ranges of penalties stipulated in these Regulations and exercise administrative penalty powers according to the nature and specific circumstances of the illegal acts. The specific measures shall be formulated by the food and drug supervision and administration departments and health and family planning departments of the State Council in accordance with their respective responsibilities."

X. Add the following provisions to Article 76: "Large-scale medical equipment refers to large-scale medical devices that use complex technology, require large capital investment, have high operating costs, have a large impact on medical expenses, and are included in the catalog management."

This decision shall take effect from the date of promulgation.

The "Medical Device Supervision and Administration Regulations" shall be revised accordingly in accordance with this decision and re-promulgated.
Regulations on the Supervision and Administration of Medical Devices

(Promulgated by Order No. 276 of the State Council of the People's Republic of China on January 4, 2000, revised and adopted at the 39th Executive Meeting of the State Council on February 12, 2014, and revised in accordance with the "Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices" on May 4, 2017)

Chapter I General Provisions

Article 1 These Regulations are formulated to ensure the safety and effectiveness of medical devices and protect human health and life safety.

Article 2 The research, production, operation, use and supervision and administration of medical devices within the territory of the People's Republic of China shall comply with these Regulations.

Article 3 The food and drug supervision and administration department of the State Council shall be responsible for the supervision and administration of medical devices throughout the country. The relevant departments of the State Council shall be responsible for the supervision and administration of medical devices within their respective responsibilities.

The food and drug supervision and administration departments of local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices in their administrative regions. The relevant departments of local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective responsibilities.

The food and drug supervision and administration departments of the State Council shall cooperate with the relevant departments of the State Council to implement the medical device industry plan and policy.

Article 4 Medical devices shall be classified and managed according to the degree of risk.
The first category is medical devices with low risk, which can be guaranteed to be safe and effective by routine management.

The second category is medical devices with moderate risk, which need strict control and management to ensure their safety and effectiveness.

The third category is medical devices with high risk, which need special measures to strictly control and manage to ensure their safety and effectiveness.

When evaluating the risk level of medical devices, factors such as the intended purpose, structural characteristics, and usage methods of medical devices should be considered.

The State Food and Drug Administration is responsible for formulating the classification rules and classification catalogs for medical devices, and timely analyzing and evaluating the risk changes of medical devices and adjusting the classification catalogs based on the production, operation, and use of medical devices. When formulating and adjusting the classification catalogs, the opinions of medical device manufacturers and operators, user units, and industry organizations should be fully listened to, and international medical device classification practices should be referred to. The classification catalogs of medical devices should be announced to the public.

Article 5 The research and development of medical devices shall follow the principles of safety, effectiveness, and economy. Encourage research and innovation in medical devices, give play to the role of market mechanisms, promote the promotion and application of new medical device technologies, and promote the development of the medical device industry.
Article 6 Medical device products shall comply with the mandatory standards for medical devices; if there are no mandatory standards, they shall comply with the mandatory industry standards for medical devices.

The catalog of disposable medical devices shall be formulated, adjusted and announced by the State Food and Drug Administration in conjunction with the health and family planning department of the State Council. Medical devices that can be guaranteed to be safe and effective by repeated use shall not be included in the catalog of disposable medical devices. Medical devices that can be guaranteed to be safe and effective by repeated use due to improvements in design, production process, disinfection and sterilization technology, etc. shall be adjusted out of the catalog of disposable medical devices.

Article 7 Medical device industry organizations shall strengthen industry self-discipline, promote the construction of a credit system, urge enterprises to carry out production and operation activities in accordance with the law, and guide enterprises to be honest and trustworthy.

Chapter II Registration and filing of medical device products

Article 8 Class I medical devices shall be subject to product filing management, and Class II and Class III medical devices shall be subject to product registration management.
Article 9 The following materials shall be submitted for the filing of Class I medical device products and the application for registration of Class II and Class III medical device products:

(i) Product risk analysis materials;

(ii) Product technical requirements;

(iii) Product inspection report;

(iv) Clinical evaluation materials;

(v) Product instructions and label samples;

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

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

Medical device registration applicants and filers shall be responsible for the authenticity of the submitted materials.

Article 10 For the filing of Class I medical device products, the filer shall submit the filing materials to the food and drug supervision and administration department of the municipal people's government where the device is located. Among them, the product inspection report can be the filer's self-inspection report; the clinical evaluation materials do not include clinical trial reports, but can be data obtained through literature and clinical use of similar products to prove the safety and effectiveness of the medical device.
For overseas manufacturers that export Class I medical devices to my country, their representative offices established in my country or designated corporate legal persons in my country as agents shall submit registration materials and certification documents of approval of the medical device to be marketed by the competent authorities of the country (region) where the registrant is located to the Food and Drug Administration of the State Council.

If the matters stated in the registration materials change, the registration shall be changed to the original registration department.

Article 11 For registration of Class II medical devices, the registrant shall submit registration application materials to the food and drug administration of the people's government of the province, autonomous region or municipality directly under the Central Government where the registrant is located. For registration of Class III medical devices, the registrant shall submit registration application materials to the Food and Drug Administration of the State Council.

For overseas manufacturers that export Class II and Class III medical devices to my country, their representative offices established in my country or designated corporate legal persons in my country as agents shall submit registration application materials and certification documents of approval of the medical device to be marketed by the competent authorities of the country (region) where the registrant is located to the Food and Drug Administration of the State Council.
The product inspection report in the registration application materials for Class II and Class III medical devices shall be the inspection report issued by the medical device inspection agency; the clinical evaluation materials shall include the clinical trial report, except for medical devices that are exempted from clinical trials in accordance with Article 17 of these Regulations.

Article 12 The food and drug supervision and administration department that accepts the registration application shall transfer the registration application materials to the technical review agency within 3 working days from the date of acceptance. The technical review agency shall submit the review opinion to the food and drug supervision and administration department after completing the technical review.

Article 13 The food and drug supervision and administration department that accepts the registration application shall make a decision within 20 working days from the date of receipt of the review opinion. If it meets the safety and effectiveness requirements, it shall be approved for registration and issued a medical device registration certificate; if it does not meet the requirements, it shall not be registered and the reasons shall be stated in writing.

When organizing the technical review of imported medical devices, if the food and drug supervision and administration department of the State Council deems it necessary to verify the quality management system, it shall organize the quality management system inspection technical agency to conduct the quality management system verification.
Article 14 If the design, raw materials, production process, scope of application, and method of use of registered Class II and Class III medical devices undergo substantial changes that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for registration change procedures; if non-substantial changes occur and do not affect the safety and effectiveness of the medical device, the changes shall be filed with the original registration department.

Article 15 The validity period of a medical device registration certificate is 5 years. If the registration needs to be renewed upon expiration, an application for renewal of registration shall be submitted to the original registration department 6 months before the expiration of the validity period.

Except for the circumstances specified in the third paragraph of this article, the food and drug supervision and administration department that receives the renewal application shall make a decision to approve the renewal before the expiration of the validity period of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed to be approved for renewal.
Registration renewal will not be granted in any of the following circumstances:

(i) The registrant fails to submit an application for renewal of registration within the prescribed period;

(ii) The mandatory standards for medical devices have been revised, and the medical devices applying for renewal of registration cannot meet the new requirements;

(iii) For medical devices used to treat rare diseases and urgently needed to respond to public health emergencies, the matters stated in the medical device registration certificate are not completed within the prescribed period.

Article 16 For newly developed medical devices that have not yet been included in the classification catalog, the applicant may directly apply for product registration in accordance with the provisions of these Regulations on the registration of Class III medical devices, or may determine the product category based on the classification rules and apply to the State Food and Drug Administration for category confirmation and then apply for registration or product filing in accordance with the provisions of these Regulations.

For direct application for Class III medical device registration, the State Food and Drug Administration shall determine the category according to the risk level and promptly include the medical devices approved for registration in the classification catalog. For application for category confirmation, the State Food and Drug Administration shall determine the category of the medical device and inform the applicant within 20 working days from the date of acceptance of the application.