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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.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 15 October 2012 | By Ansis Helmanis
Following a review conducted by its experts, China's State Food and Drug Administration (SFDA) notified provincial and municipal agencies on 12 September 2012 of the classification of 73 medical devices.
Nine devices were classified as Class III (implanted or life supporting devices); 41 as Class II (controls needed to ensure safe use); three as Class I (safety assured through routine administration); and 20 reclassified as non-devices.
Examples of new classified products include:
Read all Breaking News from RegLink
Tags: Reclassification, Classification, SFDA