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In order to promote the implementation of the medical device production quality management standards, strengthen the supervision and management of medical device production, guide the regulatory authorities to implement the Medical Device Production Quality Management Code and its related appendix on-site inspection and evaluation of the results of the inspection, according to the Medical Device Production Quality Management Code and its related appendix, the State Food and Drug The General Administration of Supervision and Administration has organized and formulated the Guidelines for on-site Inspection of Medical Device Manufacturing Quality Management Standards, the Guidelines for On-site Inspection of Sterile Medical Devices for Medical Device Production Quality Management Standards, the Guiding Principles for On-site Inspection of Implanted Medical Devices for Medical Device Production Quality Management Standards, and the Guidelines for On-site Inspection of In-body Diagnostic Reagents for Medical Device Production Quality Management Standards. The guiding principles are used to guide the regulatory authorities in implementing the Medical Device Manufacturing Quality Management Code and the evaluation of the results of the inspection, applicable to on-site verification of medical device registration, on-site inspection of medical device production licenses (including continuation or change), and various types of supervision and inspection of medical device manufacturing enterprises according to the needs of their work.
With the introduction of the Code of Quality Management of Medical Device Production and the corresponding inspection guidelines, it marks a regulation and regulation based on the Regulations on Supervision and Administration of Medical Devices, the supervision and management of medical device production, the state's key supervision of medical device catalogues, the catalogue of prohibited entrusted medical devices, and the regulations on the classification and classification of medical device manufacturers. Standardized inspection guidelines, sterile, implantable medical devices, in-body diagnostic reagents specification appendix and inspection guidelines and other normative documents as a means, other corresponding production enterprises supplier audit guidelines, water production link guidelines and other guidance documents to supplement the medical device production chain supervision of the regulatory system has been formed and constantly improved. (National Food and Drug Administration)