Pharmaceutical Network Market Analysis, the State Administration of Food and Drug Audit and Inspection Center issued the fifth batch of "National Medical Device Inspector List", statistics show that 5 batches of equipment inspectors a total of 230 people.
In fact, according to the author's observation, at present, all over the country are in fact responding to the policy, began to set up a professional inspection teamFor example, on May 21, the Guangdong Drug Administration announced that some inspectors were qualifiedOn May 9, the evaluation and inspection center of The Shandong Provincial Drug Administration was inaugurated, which marked substantial progress in the construction of specialized inspectors for the professionalization of pharmaceuticals in Shandong Province.
In addition, in addition to the above provinces, there are many provinces have also set up professional medical device inspection teams, such as Jiangxi, Shaanxi, Hebei, Shandong, Zhejiang, Shanghai and so onThis means that in medical device inspections, professional inspectors will arrive in large quantities.
In fact, according to the previous state issued "on the establishment of professional professional drug inspectors", in the medical device rectification, the establishment of professional inspectors has been the general trendAccording to the Opinion, professional medical device inspectors refer to those who, as determined by the drug regulatory department, conduct compliance confirmation and risk research on the places and activities of the management counterpart engaged in drug development and production in accordance with the law.
Specifically, the relevant regulatory authorities are mainly responsible for the medical device research and development process on-site inspection, will be from the medical device clinical trial quality management practice compliance inspectionTo undertake the overseas on-site inspection of medical devices and the production of major causes of inspectionOn-site inspection of the production process of the main medical devices by the provincial drug regulatory department, as well as the compliance inspection of the implementation of the production quality management practices.
In addition, it is worth noting that in the medical device rectification, unlicensed sales of medical devices and the sale of unregistered medical devices will face severe scrutinyThe State Administration of Drug Administration has issued a work programme for the 2020 Medical Devices "Clear Net Action", which will carry out strict checks on the sales and transactions of enterprises.
The program requires that the 3rd party platform of medical device network transaction service should implement the management responsibilities such as the verification registration, quality and safety monitoring, the release of information on product quality and safety hazards, the suppression of illegal network sales activities, the suspension of the platform service of serious illegal acts, and the related reports; It is reported that the inspection will focus on the review of qualifications, medical device traceability and sales of both sides of the bill will be the key to law enforcement officials review.
From the above can be clearly seen, the national medical device field of all links, each channel has been adequately deployed.
In fact, since the beginning of the year, the state, many provincial drug regulatory departments have issued a "medical device flight inspection management measures", sampling, flight inspection has been carried outAnd all this, in general, is to control the source of the "stain" of corporate product outflowIn the future, if enterprises want to do "to check not surprise", must strictly enforce the relevant regulations in their own production and management.
