Meaning of China Medical Device Registration Certificate Number
In the Chinese market, medical devices must be registered through the National Medical Products Administration (NMPA) and relevant local authorities responsible for medical device supervision. Only after approval can the product obtain a medical device registration certificate number. This number serves as the product’s “identity card,” providing the legal basis for market entry, sales, and use. It also carries high recognition value, signifying that the product has completed the statutory review process and received marketing authorization.
A complete medical device registration certificate number consists of six parts (as shown in the diagram below). Each part represents specific information related to product registration, clearly conveying key details such as category, origin, and regulatory status.
1. Location of the Reviewing Authority
- Provincial abbreviation: Approved by provincial-level drug regulatory authorities, applicable to domestic Class II medical devices (e.g., 苏 [Jiangsu], 闵 [Shanghai], 鄂 [Hubei]).
- 国 (National): Approved by NMPA, applicable to domestic Class III and imported Class II & III medical devices.
2. Device Origin
- 准: Medical devices manufactured by enterprises within mainland China.
- 进: Imported medical devices from foreign countries.
- 许: Medical devices originating from Hong Kong, Macau, or Taiwan.
3. Year of Initial Registration
Indicates the year the device was first approved for registration. For example, “2025” means the product was initially registered in 2025.
4. Risk Classification
- 2: Represents Class II medical devices.
- 3: Represents Class III medical devices.
5. Product Category Code
Corresponds to the last two digits of the national standard classification code, used to distinguish different types of medical devices.
6. Registration Serial Number
Consists of four digits, representing the registration sequence of that product category within the given year.
In summary, the medical device registration certificate number not only signifies the product’s legal marketing authorization but also serves as an important reference for identifying its regulatory attributes and compliance background. Correct interpretation of this code helps companies understand the product’s market access status and subsequent compliance requirements.
TALENT has extensive experience in China’s medical device registration process and can assist clients throughout the entire application procedure, including professional communication and responses with regulatory authorities. If your company plans to introduce products into the Chinese market, feel free to contact us. We will provide the most suitable regulatory strategy and registration support.
