China Agent vs Medical Device Distributor: Keep Regulatory and Commercial Roles Clear

What the China-side roles need to cover

The exact roles depend on product and company structure, but the project may require registration representation, dossier coordination, import and customs handling, distribution, tender access, training, service and post-market support.

When one partner holds several roles

A combined model can reduce handoffs, but it may also concentrate registration knowledge, customer relationships and operational control. Contract rights and data access should remain clear if the commercial relationship changes.

Questions before appointing a distributor

• Who owns and can access the registration dossier and correspondence?
• Who holds localized technical and marketing materials?
• Can the manufacturer change distributor without disrupting regulatory continuity?
• Who receives complaint, vigilance and service data?
• Which duties survive termination?

Choose the model around the device

The right structure depends on the device, evidence status, expected sales channel, service burden and the manufacturer’s long-term China commitment. Obtain qualified regulatory and legal advice before assigning formal responsibilities.