China · National Medical Products Administration · Medical devices
Review target
90 working days
regulation
Legal time limit
-
Not published
Steps
9
14 requirements
Application fee
CN¥308,800
2015 standard
Class III devices and diagnostic reagents are the highest risk group. The national agency registers both domestic and imported products. The technical review limit is 90 working days, followed by a decision within 20 working days. The certificate is valid for 5 years. High-risk devices, software as a medical device and diagnostic reagents classified as class III.
The official review target is 90 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The class iii first registration, imported is CN¥308,800 for 2015 standard.
1. Clinical trial approval for high-risk devices (60 days); 2. Clinical trial filing; 3. Registration application; 4. Acceptance and transfer to technical review (3 days); 5. Technical review (90 days); 6. Quality system inspection (30 days); 7. Request for more information (clock stopped); 8. Registration decision (20 days); 9. Certificate issued (10 days).
Outcome: Medical device registration certificate valid for 5 years. Valid for 5 years.
Legal basis: Regulations on the Supervision and Administration of Medical Devices (State Council Order 739, amended by Order 797); Measures for the Registration and Filing of Medical Devices (SAMR Order 47); Measures for the Registration and Filing of IVD Reagents (SAMR Order 48)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 518 days end to end with the official step targets, of which up to 365 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionregulation | 20 working days |
| Review targetregulation. These are official maximum working-day limits in the rules, not actual review times. Applicant answer time and inspection time are not counted. | 90 working days |
| Longest clock stopregulation. Up to 1 year to answer questions. | 365 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Class III first registration, importedApplication · 2015 standard | CN¥308,800 |
| Class III first registration, made in ChinaApplication · 2015 standard · Small and micro enterprises pay no fee for the first registration of an innovative device. | CN¥153,600reduced CN¥0 |
| Clinical trial application for high-risk devicesApplication · 2015 standard | CN¥43,200 |
Other routes in China: Urgent import in the Hainan Boao Lecheng pilot zone, Hong Kong and Macao drugs and devices in the Greater Bay Area, Small-quantity urgent import by hospitals, Expanded access at clinical trial sites, Class I device and IVD filing, Class II device and IVD registration, Innovative medical device special review, Priority registration for medical devices, Emergency registration of medical devices. See all routes on the China page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (40 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.