China Medical Device Registration
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.