Saturday, 13 June 2015

China revises GMP


The China Food and Drug Administration (CFDA) has revised its good
manufacturing practices (GMPs) for medical devices. These developments affect all medical device companies that have their own manufacturing facilities or use contract manufacturers in China.

According to the National Law Review, under the recently revised framework regulation for medical devices, the Medical Device Supervision and Administration Regulation (MDSAR) and related implementing regulations, device manufacturers with production facilities in China are required to organize their quality control systems in accordance with device GMPs and other relevant mandatory device-related standards. 

Before obtaining the necessary manufacturing licenses for Class II and Class III devices, manufacturers must be inspected by provincial food and drug regulatory authorities for GMP compliance.  Thereafter, those manufacturers must periodically conduct their own self-audits of their quality control system and submit the self-audit report to the provincial level authorities.

Since the revisions to the MDSAR, CFDA has begun to focus more on GMP compliance and enforcement.  CFDA issued a short, basic set of device GMPs for “trial implementation” in 2009, but compliance and enforcement were problematic in some areas.  These issues were initially addressed in CFDA’s 2014 enforcement “campaign” for devices, referred to as the “Five Rectifications Campaign”.  During that campaign, provincial food and drug authorities targeted and inspected some of the higher risk facilities to resolve issues.

After the Five Rectifications Campaign, CFDA issued a notice in September 2014 calling for, among other things, all newly established device manufacturers and Class III manufacturers that added new sites or switched sites to come into compliance with device GMPs by October 1, 2014.  The notice also stated that all Class III device manufacturers must become compliant by January 1, 2016, and all device manufacturers must be compliant January 1, 2018.

Posted by Tim Sandle