The regulation applies to the inspection of the overseas development and production of drugs and medical devices that have been registered in China or plan to be registered in China.
CFDA is now seeking public comments until January 24, 2018.
CFDA started their international audit program in 2015 and gradually built up inspection activity, with initial focus on manufacturers of high risk CFDA Class III devices. The new plan will cover all Class II and III devices.
The draft regulation sets up a sound regulation base for foreign audit programs and provides detailed requirements for such audits. Each Audit group will have more than 2 auditors. The working language will be Mandarin. Key processes defined in the regulation include: development of the inspection plan, initial meeting, inspection coordination, review/collection of evidence , sampling, reporting, closing meeting, completion and issue of audit report.
In case of non-conformances, the audit team should provide written notification of Drug and Medical Device Overseas Audit Defects to manufacturers within 40 working days. The time for additional testing on samples is not included in 40 working days.
Manufacturers should submit a report to CFDA on corrective actions within 40 working days of receipt of the defect notice.
This announcement is consistent with CFDA’s intention to strengthen post-market supervision on both domestic and overseas device manufacturers. Domestically CFDA has been stepping up inspection efforts for several years, including unannounced and random audits.
Now CFDA inspection is going global.
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