China FDA Focuses on Enforcement of Medical Device Good Manufacturing Practices
The China Food and Drug Administration (CFDA) has revised its good manufacturing practices (GMPs) for medical devices and taken steps to increase enforcement. These developments affect all medical device companies that have their own manufacturing facilities or use contract manufacturers in China.
Under the recently revised framework regulation for medical devices, the Medical Device Supervision and Administration Regulation (MDSAR, see our alert) 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” (our alert, here). 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. Those manufacturers that do not meet those deadlines may face enforcement actions by provincial authorities. Under the revised MDSAR, penalties for GMP violations can include fines of up to 50,000 RMB (around $8,000) if the illegally manufactured product is worth 10,000 RMB (around $1,500) or less, and up to 10 times the value of the illegally manufactured product, if it is worth more than 10,000 RMB. Penalties can also include seizure of product and loss of an entity’s manufacturing license, depending upon the specific violation and its severity.
In December 2014, CFDA issued its revised device GMPs, which went into effect on March 1, 2015. The revised GMPs add new sections and significantly revise sections already present in the 2009 GMPs related to facilities, equipment, personnel, quality control, and adverse event monitoring and analysis. In addition, CFDA has issued draft appendices to the revised GMPs that create special manufacturing requirements for in vitro diagnostics, sterile devices, and implantable devices. The comment periods on the appendices closed in February 2015, but the Agency has not issued any final rules.
Medical device companies doing business in China should continue to monitor for new guidance related to GMP enforcement from CFDA. Provincial level food and drug regulatory authorities may also issue their own guidance or enforcement policies for manufacturing sites under their jurisdiction.