China’s medical device market, currently in a rapid state of expansion, is regulated by the China Food and Drug Administration (CFDA—formerly the State Food and Drug Administration or SFDA). All medical devices must receive CFDA approval before they can be marketed in the country.
The CFDA approval process requires local testing for all but the lowest-risk devices, regardless of whether tests have been performed elsewhere.
Eligibility for market clearance in China also requires a manufacturer to have prior approval in the device’s country of origin.
Let Emergo assist you in evaluating China's medical device regulatory framework as it applies to your device(s)
Emergo relies on our global network of in-house consultants as well as industry and regulatory contacts to provide our Global Regulatory Overview Report service. Our country report for the Chinese medical device market offers incisive, actionable analysis including:
- CFDA Regulatory Background
- Product Assessment based on CFDA Criteria
- Device Classification
- In-Country Representation requirements for China
- Medical Device Registration Requirements
- Labeling and Language Requirements
- Costs and Timeframes
- Post-market Surveillance Requirements
Please contact us for more information about our Regulatory Overview Report for China.