Chinese Medical Device Market Country Report

China’s medical device market, currently in a rapid state of expansion, is overseen by the State Food and Drug Administration (SFDA). The SFDA issues registration certificates required for all medical devices sold in China.

Regulators require testing for all but the lowest-risk devices as part of the registration process in China. Third-party reviews of devices are currently not allowed in China; only the SFDA is authorized to approve devices.

Eligibility for market clearance in China also requires a manufacturer to have prior approval in the device’s country of origin.

Let Emergo Group assist you in evaluating the Chinese medical device regulatory framework as it applies to your device(s)

Emergo Group relies on our global network of in-house consultants as well as industry and regulatory contacts to provide our Global Regulatory Overview Report service. If you would like to see what these reports include, you can download a sample Regulatory Overview Report. Our country report for the Chinese medical device market offers incisive, actionable analysis including:

• SFDA Regulatory Background
• Product Assessment based on SFDA Criteria
• Device Classification According to SFDA Rules
• Authorized Representation requirements for China
• Medical Device Registration Requirements
• Labeling and Language Requirements
• Costs and Timeframes
• Regulatory Roadmap for China
• Post-market Surveillance Requirements

Please contact us for more information or a free proposal about our Regulatory Overview Report for China.