Importing medical devices into China requires a Medical Device Registration Certificate (MDRC) issued by 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.
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.
Under new regulations, the CFDA will charge different application processing fees by device classification. The new fees have yet to be determined and implemented. The MDRC is valid for 5 years from date of issue.
According to the New York Times a recent incident was yet another reminder of the increasing risks to medical device and other healthcare companies.
The FDA is alerting medical device users and manufacturers about a cybersecurity vulnerability identified for the Axeda agent and Axeda Desktop Server. The agent and desktop server are used in numerous medical devices across several medical device manufacturers and all versions of Axeda agent and Axeda Desktop Server are affected. On March 8, 2022,...
The Customer is a US based software company who recently involved in medical device industry to develop software for clinical study and patient enhanced experiences. They are seeking a quality and regulatory consultation support for FDA and CE compliance while they developing variety for software to be used either alone or in conjunction with other...
