General Office of the General Office on the medical device inspection of the work of the notice
Medical Network January 4 hearing
Provinces, autonomous regions and municipalities Food and Drug Administration:
In order to implement the General Office of the CPC Central Committee and the General Office of the State Council, "Deepen Encouragement and Reform of Examination and Approval System drug medical instruments Innovation Opinion "(Office Word [2017] No. 42) and the" Opinions of the State Council on Reforming and Reviewing the Examination and Approval System of Medical Devices for Medical Devices "(Guo Fa [2015] No. 44), effectively exert the technical support of the medical device inspection agencies and ensure Registration of medical devices order, the relevant requirements are hereby notified as follows:
First, all provinces, autonomous regions and municipalities directly under the State Food and Drug Administration should attach great importance to the inspection of medical devices, fully understand the medical device testing in the registration of medical devices an important supporting role in the national registration of medical devices from the overall situation of work to further enhance the sense of responsibility and A sense of mission, and actively implement the "Notice of the Ministry of Finance and the National Development and Reform Commission on Relevant Policies for Cleaning up and Regulating a Number of Administrative Charges" (Cai Shui [2017] No. 20) and the "General Office of the State Food and Drug Administration on Cessation of Certain Administrative Departments Do a good job after the charge to ensure funding to ensure the work of the normal notice "(Food and Drug Administration Finance Letter [2017] No. 199), for all levels of financial support for the medical device inspection agencies, properly do a good job in inspection funding, mobilization Owned medical device testing agency initiative and enthusiasm in the medical device testing aspects of technical services to ensure that the inspection work in an orderly manner to deepen the reform of the examination and approval system to encourage innovation in medical device research and development contribution to innovation.
2. The food and drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government shall further strengthen the supervision and administration of the medical equipment inspection agencies affiliated to them, provide guidance and coordination, and smooth the complaint channels for the inspection of medical devices and earnestly listen to the applications enterprise Relevant demands to understand the actual difficulties, take the initiative to coordinate related work, properly handle the relevant issues in the inspection process, supervise the inspection of medical device inspection agencies in accordance with the relevant provisions of inspection work, including the acceptance of inter-provincial inspection application, the contract clearly defined the specific inspection deadline, at Within the reasonable working time limit to complete the inspection and inspection reports, etc., for the existence of problems, we must strengthen coordination and supervision and notification, and promptly be corrected.
Third, the medical device inspection agencies in accordance with the "Medical Device Supervision Regulations" (State Council Order No. 680) and "Medical Device Registration" (Food and Drug Administration Order No. 4), "In vitro diagnostic reagents registration management approach" (Decree No. 5 of the State Food and Drug Administration), etc., the registered products commissioned by the applicants for registration of medical devices shall be inspected based on the technical requirements of the products and a test report shall be issued for product registration.The medical device inspection agencies shall strictly comply with the provisions of the Food State Administration of Drug Control on the issuance of medical device testing agencies to carry out technical requirements for pre-evaluation of medical device products requirements notice "(SFDA [2014] No. 192) to carry out pre-product technical evaluation requirements, give full consideration to the state standard , The integrity and suitability of industry standards, to ensure that inspection reports comply with the relevant requirements for product registration.