Importing IVD 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 IVD 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 IVD 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 all Class II and III IVD 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 fees have yet to be determined and implemented. The MDRC is valid for 5 years from date of issue.
Contact Asia Actual for assistance with CFDA IVD device classification, regulatory costs and timeline and clinical data requirement exemption determination.