Digging Deeper into China's New Medical Device Registration Requirements
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 Filings
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:
- Product risk analysis reports
- Product technical requirements, formerly known as product registration standards
- Clinical evaluations
- Labeling and user manuals
- Quality management system documentation
- Home country premarket licenses
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.
Class II and III Registrations
For Class II and III device registrations, applicants must provide the following documentation to the CFDA:
- Product risk analysis and testing reports
- Product technical requirements
- Clinical evaluation
- User manual and labeling information
- Quality management system documents on device design and production
- Home country premarket license
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.
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