Food and Drug Administration issued new regulations strengthening of medical device registration management

According to the State Web site, in order to further strengthen and standardize medical device registration management, State food and Drug Administration recently elaborated and issued a Declaration on the further strengthening and regulating medical device registration and management of temporary provisions ".

The full text of the regulations are as follows:

On further strengthening and regulating medical device registration and management of temporary provisions

In order to further strengthen and standardize medical device registration management, consolidation of the achievements of medical device special regulation, ensure public safety by armed force, in accordance with the medical devices regulatory Ordinance and the medical device registration management approach ", combined with the actual medical device registration management, make the following provisions.

I. production enterprises in the submission of registration documents (including the initial registration, re-registration, changes involving standards, as well as instructions of the request for the record), you should submit a product registration standards and specifications of electronic text (Word format), its content and the content of the paper file.

Second, the technical review of the sector on the registration documents for review, need additional information, it shall inform the manufacturer once, production enterprises should be in accordance with the medical device registration requirements of the management of supplementary complete at once.

Technical review of departmental receipt in the territory of the third category and imported medical equipment registration supplementary information shall be at 45 working days of the completion of the technical review.

Third, to failing to comply with the prescribed registration forms for application for, registration documents content and application project does not comply, according to declare the obvious information cannot be made safe for effectiveness evaluation as well as other cannot ensure the secure and efficient application project, the corresponding registration authorities shall make a decision not to register.

4. for the products, product standards and specifications are not re-registration of changes, production enterprises should be submitted no change, no longer submit registration product standard, registered testing report and statement of approval be re-registered, still perform original registered product standards and specifications.

For product, product standard or specification change of registered projects, production enterprises in addition to the particulars provided for by the relevant information should also be submitted to the product, product standard or specification changes before and after comparison table and the corresponding supporting documents. On serious adverse events and the evaluation confirms that it is difficult to guarantee a safe and effective medical devices, do not register again. In vitro diagnostic reagents as the in vitro diagnostic reagent registration management measures ".

5. for registered medical device, such as medical devices involving the national standards or industry standard publishing implementation, production enterprises can enroll for a certificate before the expiry of 6 months applies for re-registration.

Relates to mandatory standards of publishing, production enterprises should start implementing new standards on the date of production in accordance with the new standards organizations. Due to security reasons, for medical devices to make the registration requirements of the State food and Drug Administration will implement the standard notification.

6. for registered medical device, its management category consists of high category adjusted to the lower category, in the period of validity of medical device registration certificate shall remain valid.

Production enterprises should be in the medical device registration certificate before the expiry, according to the category after the change to the food and Drug Administration application for re-registration; its management category from low class to high class of production enterprises should, in accordance with the relevant regulations applied to re-register.

7. the inspection bodies to make full use of the technical support function, the product registration detection should be submitted by the manufacturer intends to apply to register the product for evaluation of standards, on the problems of production enterprises, should provide the proposed changes.

Inspection bodies to production companies produce medical device registration examination report should be in the inspection report indicated in the notes column of the criteria of evaluation.

8. the provinces (autonomous regions, municipalities) food and drug administration in the quality management system assessment process, to the production of the enterprise to be submitted to the second or third class medical device registration information for the first time (focus is on clinical trials) and sample production process organization for verification of authenticity.

Production enterprises in the proposed system assessment application, you should also submit the relevant information. To undertake clinical trials of medical institutions in the province of production enterprises (district and municipal) area, the location of the production enterprises provinces (autonomous regions, municipalities) food and Drug Administration may entrust responsibility for clinical trials of medical institutions located in the provinces (autonomous regions, municipalities) food and drug administration organization verification, and issue a verification opinion. State food and drug administration according to the need for third-class medical device for the first time registration information authenticity verification of spot checks.

9. not in China offices of overseas medical device manufacturing enterprises should be in the Chinese territory designated independent legal body as its agent.

Overseas medical device manufacturing enterprise change agent, it should be in accordance with the medical device registration management approach ", the relevant provisions of the registration certificate in a timely manner. Overseas medical device manufacturing enterprise in China offices or their agents shall be liable and the corresponding registration management, offshore production enterprises after the listing of liaison, collect medical device adverse event information to the corresponding registration management reports, medical device recall of marketed products, production enterprises guarantee product quality and after-sales service of the joint and several liability.

10. outside of the medical device manufacturing enterprises on the territory of China, as well as the agent of the Attorney for the information statements of self assurance of authenticity, shall be approved by their host countries (regions) notarization Institute.

11. the provisions of their promulgation.