Class III medical devices subject to clinical trials 2020

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In: Inspection/Test, Medicine/medical devices, NMPA, registration
n September 18, the national medical device administration issued the catalogue of class III medical devices subject to clinical trial approval (2020) and its revision instructions. Compared with the 2014 edition, the catalog added the description of common principles of applicable products, adjusted 6 catalogue product descriptions, deleted 2 products and updated classification codes. Add general principle description of applicable products, that is, “compared with the products already on the market at home and abroad, the medical devices which adopt new design, materials or mechanism, and / or are suitable for new application scope and have higher risk to humanRead More →

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