Healthcare, Industry News, Medical Devices, Regulatory Affairs

CFDA issues new document submission rules for Class II and Class III devices

The CFDA has issued new requirements for Chinese market authorization applicants who need to submit hard and soft copies of their registration applications to CFDA.

According to the CFDA announcement, Chinese market applicants with Class II and III devices will have to submit not only their original registration dossiers, but also photocopies and soft copies in PDF format, as well as a declaration of consistency attesting that all three submission formats contain the same information. The new documentation rules will be effective from November 2016.

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