Importing medical devices into China requires a Medical Device Registration Certificate (MDRC) issued by the National Medical Products Administration (NMPA), previously the China Food and Drug Administration (CFDA). This document is technically owned by the foreign manufacturer, but is controlled by the Legal Agent listed on the certificate who is responsible for the registration application. Products must have home country approval prior to applying for registration in China.
Medical device registration in China is now valid for 5 years (previously it was valid for only 4 years). If a manufacturer wants to renew a device’s registration, a renewal application should be submitted 6 months prior to the expiration date to the same department that received the original registration submission.
Medical Device Classification
Low Risk Class I medical devices are subject to a filing process with applications submitted to the CFDA. Administrative review and MDRC issuance takes about 4 weeks from application submission.
Medium Risk Class II and High Risk Class III medical devices are subject to a registration process with applications and supporting documentation submitted to the CFDA. Product testing certificates issued from a (local) CFDA-certified laboratory are a required element of the application. Local clinical test data is also required for most Class II and III devices. Review and MDRC issuance can take 12 to 24 months.
If a medical device company wants to register a device that is not manufactured in China, it is required that the company provide device samples to the NMPA for testing.
In the case of registering Class II and Class III devices, manufacturers are obligated to send the appropriate documents showing that the device has been approved in its country of origin (i.e. CE Mark, 510(k) letter, ISO 13485 certification, approved Premarket Approval Application). It may also be required to provide supportive clinical data along with the application. All product information on packaging and labeling must be translated to Simplified Chinese.
Foreign manufacturers must also hire China-based agents that will represent their interests in China. The responsibilities of the designated agents include providing technical service and maintenance support for the device, assisting with device recall (if recall is required), overseeing the registration process, and providing support for the manufacturer in case adverse events occur due to device malfunction.
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