Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the Central Government, Food and Drug Administration of Xinjiang Production and Construction Corps, China Academy of Food and Drug Administration:
To strengthen the supervision of post-market medical equipment and standardize the order of medical apparatus and instruments market, timely detection and control risk, the administration of food and drug supervision departments at all levels shall, in accordance with the requirements, the organization carries out the proper medical equipment quality supervision, the work of proper (hereinafter referred to as the work), has made certain achievements, but there are still some problems, such as: proper for the working emphasis and varieties of proper organization coordination is not strong, the focus is not prominent, pertinence is not strong, inadequate sample selection, sampling inspection time lack of normative, risk assessment and treatment of insufficient, reports of information in a timely manner, and other issues. In order to further strengthen the management of medical device sampling and give full play to the role of sampling in supervision, the relevant requirements are hereby notified as follows:
First, strengthen the sampling work responsibility consciousness
Provincial food and drug supervision departments to further improve the knowledge of medical device regulatory work, earnestly implement the administration of "four haves" requirement, strengthen the leadership, improve the work responsibility consciousness, to strengthen the institutions of medical apparatus and instruments of proper work, staffing and financial support, regulate the behavior of sampling inspection and strengthening to sample the result of analysis is applied, proceed with the verification disposal, ensure that the national and provincial medical apparatus and instruments of proper work.
Second, further strengthen the provincial sampling work
Each provincial food and drug regulatory department shall, while implementing the national medical device supervision and sampling test plan, scientifically formulate the provincial medical device supervision and sampling test plan in accordance with the principle of consistent goals, complementing each other and avoiding duplication. The selection of selected varieties of provincial-level medical devices shall mainly take into account the products not listed in the catalog of National Key Medical Devices under Supervision in the current year, the varieties in the Catalog of Provincial Key Medical Devices under Supervision, and the products listed in the sampling test plan of the previous year but not actually sampled. At the same time, a follow-up sampling inspection shall be carried out for the products not conforming to the standards in the previous year.
Iii. Standardize the disposal of products that do not conform to the standards
The relevant food and drug regulatory departments shall deal with the products found in sample tests that do not conform to the requirements of the standards in accordance with Article 66 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 650 of the State Council), and supervise the production enterprises to carry out relevant work in strict accordance with Article 52. If the circumstances are serious, such as the repeated non-compliance with the standards or the follow-up sampling inspection is still not in compliance with the standards, it shall be investigated and dealt with strictly according to law, and measures such as suspending production for rectification and ordering recall of products shall be taken immediately.
At the same time, the relevant food and drug regulatory authorities shall carry out systematic inspection on the production enterprises that do not meet the standards. If any problem is found that may affect the quality of other products, the relevant food and drug regulatory authorities shall immediately order the production enterprises to suspend production and suspend business for rectification. If the cause has not been found out or the rectification has not been made, no production shall be resumed. Those suspected of committing a crime shall be promptly handed over to the public security organ.
Iv. Urge enterprises to fulfill product recall responsibility
All provincial food and drug regulatory departments should strengthen the publicity of relevant laws and regulations on the disposal of products that do not conform to the standards, and supervise the implementation by enterprises. The provincial food and drug regulatory department where the relevant medical device manufacturer is located shall supervise the recall of the enterprise. If the manufacturer fails to organize the recall, it shall be ordered to recall. If the recall level is not consistent with the risk situation, it shall be ordered to revise the recall level. If it is found that the medical apparatus and instruments that do not conform to the standards cause harm to human body or there is evidence that they may endanger human health, emergency control measures may be taken to suspend production, import, business operation and use. Other food and drug regulatory departments at various levels shall actively cooperate and supervise the operating enterprises and users within their respective administrative areas to assist in product control and recall.
The provincial food and drug regulatory authorities shall timely upload the relevant investigation results and product recall information to the National Medical Device Sampling Inspection Information System.
5. Further promote the reporting and disclosure of inspection information
Provincial-level food and drug regulatory departments should attach great importance to the reporting of sampling inspection and disposal information, and ensure that special personnel are responsible for timely and accurate information reporting. In addition, the provincial food and drug regulatory authorities shall timely release to the public the disposal results of non-conforming products as well as the sampling and disposal results of provincial medical devices in the national announcement on the quality of medical devices.
Strengthen the comprehensive analysis and application of the sample test results
Food and drug regulatory departments at all levels should strengthen the organization of statistical analysis of supervisory sampling data, strengthen horizontal comparison and vertical analysis of inspection results, timely find systemic and regional regulatory risks, and grasp the trend of product quality and safety. All the provincial food and drug regulatory departments should constantly increase the analysis and application of sampling test results, and do a good job in the quality assessment of the products sampled at the provincial level. Identify, analyze and evaluate the risk factors that may affect the quality safety, reliability and effectiveness of the products, and formulate and implement risk prevention and control measures.
Seventh, strengthens the sampling inspection work standard management
All provincial-level food and drug regulatory departments shall strengthen the standardized management of sampling and inspection work, assign special persons to be responsible for it, and deliver it to the marked production enterprises or sampled enterprises and units within 5 working days from the date of receipt of the inspection report, and input relevant working conditions into the sampling inspection system in a timely manner to ensure the quality and efficiency of sampling inspection work. All provincial food and drug regulatory departments should strengthen the management of the internal work process of relevant medical device inspection institutions and carry out supervision and sampling inspection in strict accordance with the inspection plan.
China Academy of Food and Drug Testing should strengthen the collection and analysis of unqualified products in the national medical device supervision and sampling inspection. Where an inspection institution issues a false inspection report, the General Administration will deal with it according to law.
The CFDA will organize the supervision and examination of the provincial food and drug regulatory departments to undertake the sampling inspection of national medical devices and organize the supervision and examination of the sampling inspection of medical devices at the provincial level. All provincial-level food and drug regulatory departments shall supervise and self-inspect the sampling inspection work organized or undertaken by them to ensure smooth progress of all work as planned. In addition, the provincial level and above of proper food and drug supervision department to undertake the work of the inspection institutions to strengthen management and for inspection agencies in the process of testing in violation of the "national medical apparatus and instruments random inspection procedures" and "regulations on medical equipment quality supervision and random inspection, and directly affect the test results, shall be reported, and no longer tasks entrusted supervision to sample within a year.
General Office of CFDA
February 2, 2016