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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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| 22 June 2012 | By Louise Zornoza
China's State Food and Drug Administration (SFDA) has launched a new medical device manufacturing inspection program for the Provinces and Municipalities to implement during an inspection of a medical device manufacturing site.
The inspection program's 15 articles require local regulatory authorities to undertake a number of measures, such as a follow-up inspection in cases where serious flaws are uncovered and ensuring that the company has established a quality management system. The annex to the program includes on-site inspection and inspection report forms.
Read more:
SFDA - Medical Device Manufacturing Inspection Program
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Tags: SFDA, Inspection, medical device