Register imported medical devices and IVDs with the NMPA.
Classification, registration testing, clinical evaluation and the China CER, working with your legal agent in China.
Key facts
Pathways
- Class I: filing with the NMPA for imported devices
- Class II and III: registration with the NMPA, reviewed by CMDE
- Clinical evaluation through the exemption catalogue, comparison with a similar device, or clinical trials in China
- Registration testing by qualified laboratories, or the manufacturer's own testing where permitted
What you will need
- Product technical requirements
- Registration test report
- Clinical evaluation documentation, including a China CER where applicable
- Evidence of marketing approval in the country of origin, where required
- Chinese-language labelling and IFU
Sequence and decision points
- 01ClassifyConfirm the class from the NMPA classification catalogue.
- 02Appoint a legal agentA China-based entity responsible alongside you.
- 03TestRegistration testing against product technical requirements.
- 04Clinical evaluationExemption, comparison route or clinical trial in China.
- 05Submit and reviewCMDE technical review and supplementary questions.
- 06CertificateRegistration certificate issued, valid for five years.
Compliance with China's medical device GMP; the NMPA may inspect overseas manufacturing sites.
A legal agent in China is required for imported devices and shares responsibility with the manufacturer.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
Review timelines are set in NMPA rules; supplementary information requests add time. Registration fees apply to imported Class II and III devices.
After market entry
- Adverse event monitoring and reporting
- Change registration for significant changes
- Registration renewal every five years
- UDI for applicable devices
How we help
- China classification and pathway strategy
- China CER with CNKI searches and Chinese-language appraisal
- Clinical evaluation route selection
- Dossier preparation support with your legal agent
- Post-market and renewal planning
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about China
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Do we need a clinical trial in China?
Not always. Many devices use the exemption catalogue or a comparison with a similar marketed device. Higher-risk or novel devices may need trials in China.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.