Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
NMPA
Register your medical device in China.
Register your medical device in China through Filing (Class I), provincial Registration (Class II) or national NMPA Registration (Class III), with a dedicated In-country Agent.
Speak to a specialistThe authority
National Medical Products Administration
NMPA
Since 2018
China
Replaced the CFDA in 2018. Reporting to the State Administration for Market Regulation, it regulates medicines, medical devices and cosmetics in China.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk, Filing (notification) | Bandages, non-surgical masks, basic instruments |
| Class II | Moderate risk, provincial Registration | Diagnostic equipment, infusion pumps |
| Class III | High risk, national NMPA Registration | Implants, pacemakers, advanced surgical equipment |
Registration process
How we manage your project
- 01
Prior approval in the country of originvariable
Approval in the country of origin is mandatory before submitting in China
- 02
In-country Agent2-4 weeks
Appoint an authorised local agent for representation before the NMPA
- 03
Local testing (Class II/III)4-8 months
Mandatory in-country testing at authorised Chinese laboratories
- 04
Technical dossier4-6 months
Prepare the submission in Chinese in accordance with CMDE technical guidelines
- 05
Submission and CMDE review12-36 months
The Center for Medical Device Evaluation assesses the dossier
- 06
Certificate issuance1-2 months
NMPA certificate issued and registration in the Chinese regulatory system
Total timeframeClass I: 1-3 months. Class II: 12-18 months. Class III: 24-36 months
Local representativeIn-country Agent
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | Adverse event reporting, Annual Quality Report and recall procedures through the NMPA |
| Renewal | 5 years, with renewal requested 6 months before expiry |
| Required QMS | ISO 13485 and China GMP (revised November 2025, effective November 2026) |
How HSC helps
Your company in the world's second-largest healthcare market.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about NMPA
Next step
Ready to start your project in China?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist