Liaoning, Henan and other five provinces actively respond to the classification and classification of medical device enterprises supervision and management

October 16th, the supervision and management of medical device enterprises has been the focus of government inspection, since the CFDA issued "on the issuance of medical device enterprises classification supervision and management provisions of the notice", each province has been actively corresponding.,
, 2015, Liaoning Province implemented classification and classification supervision of medical device operating enterprises, and will conduct a survey of medical device operating enterprises in the province to determine the level of supervision.
it is understood that Liaoning Province will be medical device business enterprises divided into three levels of supervision, before January 20 each year dynamic medical device business supervision level division, and to the public.
three-level supervision is the highest level of risk supervision, mainly for medical device business links of the key supervision directory involved in the operation of enterprises, for other medical device production and operation enterprises to provide storage, distribution services operating enterprises. Business enterprises with administrative penalties and poor rectification and bad credit records in the previous year will also implement three levels of supervision. Secondary supervision is the supervision of wholesale enterprises operating the second and third types of medical devices in addition to three levels of supervision. The first-level supervision is the supervision of other medical device operating enterprises except the second and third-level supervision.
the three-level supervision of the operating enterprises, the municipal food and drug supervision departments will be inspected not less than once a year. For operating enterprises that implement secondary supervision, the departments of food and drug supervision at the county and district levels shall inspect not less than once every two years. For operating enterprises that implement first-level supervision, the county and district-level food and drug supervision departments will randomly select more than 30% of the enterprises within their administrative areas to carry out supervision and inspection, and reach full coverage within 3 years.Henan
it is understood that Henan Province in September also carried out the province's medical device business enterprises to implement classification and classification supervision work.
henan's hierarchical supervision establishes an effective classification and classification supervision system and supervision mode for medical device operating enterprises, strengthens the supervision and management of medical device operations, standardizes the order of medical device operations, and enhances the level of medical device safety and security.Anhui Province
Anhui Province issued the "Anhui Province Medical Device Manufacturer Classification Supervision and Management Regulations
the Implementation Rules of the State Food and Drug Administration, "Medical Device Production Enterprise Classification and Classification Supervision and Management Regulations", based on the focus on the refinement of the three levels of regulatory responsibilities, strict supervision procedures and requirements, clear scope of flight inspection work, the addition of "double interview" regulatory measures, credit system construction organic combination of these five aspects., Hainan Province,
Province has also issued the "Hainan Province medical device production enterprises classification classification management measures", Hainan Province medical device business (wholesale) enterprise classification and classification management measures. The supervision of medical device production and operation enterprises is divided into four levels, and the medical device business enterprises are evaluated on an annual basis to determine the level of supervision. And the corresponding level of supervision of enterprises to determine the frequency of inspection, the implementation of four-level supervision of enterprises, at least once a year a full-project inspection;Shanxi Province
Shanxi Province Food and Drug Administration has issued "on the implementation of classification classification to strengthen the daily supervision and management of medical device manufacturers notice" and other documents, the implementation of classification classification supervision responsibilities, regulate the operation of the enterprise quality system, pay attention to risk supervision, and comprehensively strengthen the supervision of medical device manufacturers.
is the implementation of classification and classification supervision. The daily supervision and management of medical device manufacturing enterprises will determine four regulatory levels and implement hierarchical responsibility in accordance with the principle of territory supervision.
is to standardize the quality system of enterprises. Clarify the requirements for medical device manufacturers to submit self-examination reports on the operation of the annual quality management system.
is to focus on risk regulation. We will formulate a catalogue of medical device products and enterprises under provincial key supervision, strengthen dynamic supervision of high-risk enterprises and high-risk products, and improve the awareness of quality responsibility and quality management. (Pharmaceutical Network)