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Who it is for
- Overseas device manufacturers, brand owners and distributors planning China market entry.
- Regulatory, strategy and due-diligence teams evaluating classification, evidence gaps, timing and ongoing obligations.
What it covers
- Device status, intended use, mechanism and borderline-product classification questions.
- Class I, II and III and their implications for filing/registration and evidence burden.
- Overseas applicant and Chinese agent roles, technical requirements, testing and clinical evaluation.
- Chinese labels/IFU, UDI, customs information and post-market responsibilities.
Key questions addressed
- Is the product a medical device in China, and is its management class established?
- What evidence and local responsibility would the proposed route require?
- Are the regulatory burden and continuing obligations compatible with the business plan?
Important limitations
- Not filing instructions, submission templates, clinical/test protocols or agent-selection advice.
- No guaranteed approval or timeline; exceptional clinical-use arrangements are not presented as normal commercial trial-import routes.
Does the guide replace classification or registration review?
No. It is an early decision framework for identifying the relevant route and uncertainties, not an authority determination or registration service.
Contact support
support@chinacustomscompliance.com