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Regulatory Focus™ > News Articles > China: SFDA Launches New Device Compliance Program

China: SFDA Launches New Device Compliance Program

Posted 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.

SFDA - Medical Device Manufacturing Inspection Program