China · National Medical Products Administration · Combination products
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
A drug-device combination product is made as one unit. It is registered as a drug if the drug action is primary, or as a device if the device action is primary. When the primary mode is unclear, the applicant asks the national device standards center to decide first. The lead review center can share the file with the other center for joint review. Products that combine a drug and a device in a single entity.
1. Classification request if unclear; 2. Registration as drug or device; 3. Lead review, joint review when needed; 4. Decision.
Outcome: Drug registration certificate or device registration certificate, based on the primary mode of action.
Legal basis: NMPA Notice 2021 No. 52; Provisions for Drug Registration (SAMR Order 27), Article 122; SAMR Order 47, Article 122
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. |
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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.