Global devices into China

Bring a strong medical device to China with a clearer local path.

CUMEDI provides China medical device market-entry support for international manufacturers by organizing regulatory, partner and commercial workstreams around one product and business case.

Opportunity & pathway assessment

Clarify the product, intended use, existing approvals, evidence status and commercial objective before selecting a China route.

Regulatory workstream coordination

Map the likely classification and registration questions, then coordinate with qualified regulatory specialists for formal advice and submissions.

Local partner development

Identify and screen potential import, distribution, clinical, service or commercial partners against the agreed market role.

Launch & operating support

Coordinate localized materials, partner handoffs, commercial milestones and the evidence needed for the next investment decision.

Important boundary

Coordination is not regulatory approval.

CUMEDIStructures the project, gathers information, coordinates local specialists and supports partner development.

Qualified specialistsProvide formal classification, registration, testing, clinical and legal advice where required.

Device companyOwns product evidence, applicant decisions, claims and final commercial authorization.

First discussion

Bring the evidence you already have.

Intended use, technology, models and manufacturing sites.
Existing registrations and marketing history.
Technical, clinical and quality-system evidence status.
Preferred China model: importer, distributor, license or local entity.
Commercial priorities, timing and internal decision owner.

Regulatory reference reviewed August 2026: China’s current registration provisions state that imported Class II and Class III devices are handled through registration, while imported Class I devices are filed. Product-specific classification and requirements must be confirmed.

Read the NMPA provisions

Market-entry guides