China Medical Device Regulatory Strategy Report
China's medical device market, currently in a rapid state of expansion, is regulated by the China Food and Drug Administration (CFDA). All medical devices must receive CFDA approval before they can be marketed in the country, though Class I devices are subject to a simpler notification process.
Chinese medical device regulations requires local testing for all but the lowest-risk devices, regardless of whether tests have been performed elsewhere, for CDFA approval.
Eligibility for market clearance in China also requires a manufacturer to have prior approval in the device’s country of origin (or country of manufacture).
Let Emergo assist you in navigating medical device registration in China and the CFDA approval 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 Regulatory Pathway 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 Vigilance Requirements