China · National Medical Products Administration · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
7 requirements
Application fee
-
Class I devices and diagnostic reagents are filed, not registered. Makers in China file with the city-level drug authority. Overseas makers file with the national agency through a company in China. Filing is complete when compliant documents are submitted, and the information is published within 5 working days. Low-risk devices and diagnostic reagents where routine control is enough.
1. Prepare filing documents; 2. Submit filing; 3. Filing complete; 4. Information published (5 days).
Outcome: Filing number; the product can be made and sold.
Legal basis: Regulations on the Supervision and Administration of Medical Devices (State Council Order 739), Articles 13 to 15; 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 5 days end to end with the official step targets. 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
| 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 II device and IVD registration, 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.