China · National Medical Products Administration · Medical devices
Review target
60 working days
regulation
Legal time limit
-
Not published
Steps
8
12 requirements
Application fee
CN¥210,900
2015 standard
Class II devices and diagnostic reagents are medium risk. Provincial drug authorities register domestic products, and the national agency registers imported ones. The technical review limit is 60 working days, followed by a decision within 20 working days. The certificate is valid for 5 years. Medium-risk devices, software as a medical device and diagnostic reagents classified as class II.
The official review target is 60 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The class ii first registration, imported (domestic class ii fees are set by each province) is CN¥210,900 for 2015 standard.
1. Clinical trial filing; 2. Registration application; 3. Acceptance and transfer to technical review (3 days); 4. Technical review (60 days); 5. Quality system inspection (30 days); 6. Request for more information (clock stopped); 7. Registration decision (20 days); 8. 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); SAMR Orders 47 and 48 (2021)
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 428 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. | 60 working days |
| Longest clock stopregulation. Up to 1 year to answer questions. | 365 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Class II first registration, imported (domestic class II fees are set by each province)Application · 2015 standard | CN¥210,900 |
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 III 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 (33 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.