In order to guide medical device manufacturers to do quality management in accordance with the technical requirements of registered or filed products, strengthen quality control during procurement, production and inspection, strictly release finished medical device products, and improve product quality assurance level, according to "Medical Device Production Supervision" Administrative Measures (State Food and Drug Administration Order No. 7) and Medical Device Production Quality Management Regulations (State Food and Drug Administration announced in 2014 No. 64), the State Food and Drug Administration organized the development of "medical The Guide for Quality Control and Finished Release of Equipment Manufacturers is hereby released.
announce.
Attachment: Guidelines for quality control and finished product release for medical device manufacturers
Food and Drug Administration
December 30, 2016
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