China · National Medical Products Administration · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
-
For a public health emergency, the agency can use emergency registration for devices with no similar product in China, or when supply is not enough. Testing, quality system inspection and technical review run in parallel. Devices can also be used in an emergency within a set scope and period after expert review. Devices needed for a public health emergency.
1. Emergency registration application; 2. Parallel testing, inspection and review; 3. Decision.
Outcome: Emergency registration.
Legal basis: Measures for the Registration and Filing of Medical Devices (SAMR Order 47), Articles 76 to 78; Regulations on the Supervision and Administration of Medical Devices, Article 19
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
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, Class III device and IVD registration, Innovative medical device special review, Priority registration for 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 (4 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.