China News Service, April 3rd According to the website information of the State Drug Administration, on the 3rd, the State Food and Drug Administration held a special teleconference on strengthening the supervision of the export quality of medical equipment for epidemic prevention and control. The meeting pointed out that if there is evidence that there is a problem with the quality of export products, production should be immediately stopped, rectified, and the problem should be clarified.
Data map: Workers rush to make medical protective clothing. Photo by China News Agency reporter Zhang Jinchuan
The meeting demanded that the situation of enterprises should be swiftly clarified, and the focus of supervision should be ensured. Provincial drug regulatory agencies should establish a list of export medical device companies, implement dynamic adjustments, and export medical device products to medical device manufacturers and operating companies to ensure that they are aware of them; supervise and guide export companies to improve the export product archives and ensure the product export process Traceability; timely notification of the list of export enterprises to the local government.
The meeting pointed out that it is necessary to determine a person responsible for reporting to ensure the quality of information disclosure. The State Bureau has continuously published the five categories of products approved by the drug regulatory department (new crown virus detection reagents, medical protective clothing, medical masks, respirators, infrared thermometers) on the website of the State Drug Administration. A special person is responsible for reporting the information.
The meeting was clear, accurately grasped the legal positioning, and standardized export sales certification. For enterprises that have not obtained the medical device registration certificate and production license in China, or have not completed the medical device product filing and production filing, no export sales certificate can be obtained.
It was mentioned at the meeting that the organization system is capable and strengthens supervision and inspection. Provincial drug regulatory departments must quickly mobilize the province's resources, establish a medical device manufacturing and operation enterprise inventory system and a supervisory staff responsibility system, aim at key targets, focus on key issues, focus on outstanding issues, and strengthen control measures. There is evidence that the quality of exported products If there are any problems, the production shall be stopped and rectified immediately, and the problems shall be clarified. If the problem is not verified and the responsibilities are not clearly separated, production and operation shall not be resumed.
The meeting stated that the supervision of export products should be emphasized and the supervision and inspection efforts should be strengthened. Provincial drug regulatory departments shall appropriately adjust sampling inspection items in accordance with the needs of epidemic prevention and control and the need to ensure the quality of exported products. The random inspection shall cover all kinds of products produced by enterprises in this province, especially those newly approved by the enterprises during epidemic prevention and control.
At the same time, the meeting also required that drug regulatory agencies at all levels should strictly control system inspection, registration inspection, clinical trials, and technology in accordance with the requirements of medical device review and approval on the premise of ensuring product safety, effectiveness, and controllable quality in accordance with relevant requirements. The review, administrative examination and approval, and orderly review and approval of epidemic prevention and control machinery should be done in an orderly manner to ensure product safety, effectiveness, and controllable quality.
In response to the violations of laws and regulations found in the supervision, the meeting emphasized that we must implement the "four strictest" requirements, strictly implement the responsibility of corporate entities and territorial management, and investigate and deal with cases of violations of laws and regulations, and strictly punish no punishment. Strengthen the listing supervision of major cases, strengthen the connection of executions of cases, highlight the punishment of illegal acts, and form a high-pressure situation and deterrent power.
It is reported that the State Food and Drug Administration will form a joint supervision team with the relevant departments of the State Administration of Market Supervision to conduct special supervision in some regions with large outbreaks of medical equipment for epidemic prevention and control, and incorporate the supervision of the quality of medical equipment export products in various places Annual assessment and evaluation.