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Regulatory News | 13 August 2014 | By Stewart Eisenhart •
Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
Emergo Group colleagues in China have provided additional details on recently published changes to the China Food and Drug Administration’s (CFDA) medical device registration process.
CFDA Administrative Order No. 4 covers new and revised requirements for Class I, II and III device registrations in China that will take effect 1 October 2014.
Class I medical device manufacturers will have to submit filings rather than registrations to the CFDA, which could lead to shorter approval times for such devices. Required documentation for Class I filings include:
Once a filing is submitted to the CFDA, officials will conduct a completeness check to see that all required documents have been included, rather than a technical review. Any changes to the filing will require the applicant to submit a modified application to the CFDA.
For Class II and III device registrations, applicants must provide the following documentation to the CFDA:
Chinese regulators plan to complete initial reviews of Class II registrations within 60 working days and for Class III registrations within 90 working days. Those timeframes will not apply, however, in instances where external expert reviews or combination device-drug reviews are necessary.
In cases where CFDA reviewers request additional information for Class II or III applications, applicants have one year to submit that information to regulators. Additional information submitted will be reviewed within 60 working days, and licenses will be issued within 10 working days of technical reviews.
Finally, medical device licenses issued by the CFDA will remain valid for five-year periods instead of four.
Read more about this topic:
New Chinese Medical Device, IVD Regulations Take Effect in October 2014
Chinese Medical Technology Market Primed for 17% Growth According to Citigroup
Tags: Administrative Order No. 4