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.
Posted by Tim Sandle
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