CFDA prunes medical device standards management guidelines

CFDA amends Medical Device Guideline

The China Food and Drug Administration (CFDA) has amended its management guidelines for medical devices standards, reflecting measures to deepen standardization reforms issued by the State Council from March 2015. The medical devices standards management guideline was first released in 2002, and sets out both mandatory and recommended standards and technical requirements relating to the development, production, operation, use, supervision, and management of medical devices.

The amendment, which takes immediate effect, increases the number of articles in the guideline from 24 to 36. The new clauses add product-related technical requirements, while erasing the entire chapter on the formulation and review and approval of product standards, as well as some contents relating to medical device registration standards. On top of that, the document makes clear the relationship between product technical requirements and mandatory versus recommended standards, adds details relating to implementation and supervision of standards, further refines management responsibilities and revision procedures, and provides details related to standards transparency and follow-up evaluation, among others.

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