Further Analysis of China's IVD and Medical Device Labeling Rules

Emergo colleagues in China have provided additional analysis of new requirements from the China Food and Drug Administration (CFDA) regarding in vitro diagnostic (IVD) device registrations.

According to CFDA Administrative Order No. 5, all Class I, II and III IVDs imported into China will have to undergo new CFDA registration requirements beginning October 1, 2014.

Class I IVD Chinese market applications will go through completeness checks rather than technical reviews, and will be issued vouchers of filing if the CFDA finds that all necessary documents have been included in applications. Vouchers will not expire; any changes a company makes to its Class I IVD filing will require submission of a modification application.

 Class II and III IVD manufacturers must go through registration processes similar to those of Class II and III medical device registrants. Registration may involve inspection of applicants’ quality management systems at the CFDA’s discretion.

Initial CFDA reviews for Class II IVD applications will take 60 business days, while initial reviews for Class III IVDs are expected to take 90 business days, according to the order. In cases where reviewers request additional information, applicants will have one year to submit additional materials; CFDA staff will then have 60 business days in which to review additional information.

In instances where Chinese regulators determine that quality system inspections are necessary, inspection times will add to the overall registration timeframes above.

Following final technical review, CFDA staff will issue licenses for Class II and III IVD registrations within 10 business days. Licenses will be valid for five years, rather than four under China’s existing IVD regulatory framework.

Stewart Eisenhart

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