China rolls out devices international audit program

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Speaking at the China International Medical Device Regulatory Forum (CIMDR) in Guangzhou on 24 September, China Food and Drug Administration (CFDA) Deputy Commissioner Jiao Hong set out the agency’s plans for an international medical device manufacturing audit program.

There have been signs China was considering starting international audits from some time.  CFDA recently updated its medical devices Good Manufacturing Practice (GMP) code.  The introduction of user fees earlier this year included a controversial differential charge for non-Chinese manufacturers of higher risk devices, justified on the grounds that foreign manufacturers cost more to regulate because of the additional costs of international  audit visits.

So what exactly is planned?

Also speaking at CIMDR was Sun Li, CFDA’s postmarket regulatory chief.  He explained that the agency would be starting slowly and ramping up effort over the next few years.  Just two pilot audits are planned for the last half of 2015, followed by ten more in 2016.  Audits would focus on manufacturers of high risk CFDA Class III devices.

CFDA has limited expertise and resources in international audit – so it’s clear there’s a limit to how large a program can be implemented and how quickly it may grow.  Which is why the agency is looking towards opportunities for international cooperation.

China joined the IMDRF in March 2013.   IMDRF is currently operating its Medical Device Single Audit Program – which provides a single audit covering the requirements of Australia, Brazil, Canada, Japan and USA.  Interestingly Jiao Hong quite specifically flagged that China intended cooperating with international agencies in the roll out of its foreign audit program. China has been a part of the IMDRF’s  MDSAP working group from the outset and actively contributed to the development of the process.    It remains to be seen if China will seek to join in the actual MDSAP pilot audit program.  Certainly the latest revision of China’s GMP code brought closer alignment with ISO 13485 and FDA’s Quality Systems Regulations (21 CFR 820), so it may be that China could at least cooperate on quality systems aspects of MDSAP audits.

So what may a manufacturer expect from a CFDA inspection?  Well – the CFDA GMP code includes all of the elements found in ISO 13485 and 21CFR 820.  So expect the same ground to be covered.  Just what particular nuances will apply and priorities will be followed by CFDA remains to be seen.

In summary – China certainly intends establishing an international medical devices audit presence.  However the signs are also there that it intends doing so in a measured way, will focus on high risk devices and leveraging international harmonisation efforts.

China GMP Code (English Translation)
China User Fees
China Classification rules (English Translation)

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