Medical device product registration and importation in 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 and can now be submitted online through the new Electronic Regulated Product Submission (eRPS) system, along with all new applications.
MEDICAL DEVICE CLASSIFICATION
Low Risk Class I medical devices are subject to a filing process with applications submitted to the NMPA. 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 NMPA. Product testing certificates issued from a (local) NMPA-certified laboratory are a required element of the application. Local clinical test data is also required for most Class II and III devices.
As of October 2022, the NMPA has published their classification catalogue adjustments for comment. More information available here. Recently, the NMPA has updated the classification status of Sodium Hyaluronate products. Read more about the notice here.
Asia Actual’s new tool for RA professionals, R.O.S.E., can help identify Same-Type devices (aka Predicate Devices) and their classification. Click here to learn more.