How to distinguish between Class II and Class III registration certificate numbers for medical devices

The medical device registration certificate number is an important identifier for identifying the category of medical devices, and correctly distinguishing between Class II and Class III medical devices is crucial for medical practitioners and related enterprises. Below, I will provide a detailed explanation on how to identify the category of medical devices based on their registration certificate number.

Basic structure of medical device registration certificate number

The registration certificate number for medical devices in China usually consists of the following parts:

Abbreviation of the location of the registration and approval department: for example, "Guo" represents the approval of the National Medical Products Administration, while "Beijing", "Shanghai" and other names represent the approval of provincial-level drug regulatory departments

Registration form: "Equipment" represents medical devices

Registration category: The numbers "1", "2", or "3" respectively represent Class I, Class II, and Class III medical devices

Product classification code: composed of letters and numbers

Registration year: 4 digits

Serial number: usually 4 digits




How to identify Class II and Class III medical devices

The key point lies in the third part of the registration certificate number:

Class II medical devices: The registration certificate number contains the words "approved" or "entered", and the third digit is "2". For example, "2" in "National Medical Device Approval 2015324 *****" indicates that this is a Class II medical device.

Three types of medical devices: The registration certificate number contains the words "approved" or "entered", and the third digit is "3". For example, the "3" in "National Medical Device Approval 2018312 *****" indicates that this is a Class III medical device.




Other identification methods

Risk level: Class III medical devices have the highest risk level, followed by Class II. The three types are usually devices implanted in the human body, used to support and maintain life, or potentially dangerous to the human body.

Approval authority: Class III medical devices are approved by the National Medical Products Administration, while Class II devices are approved by provincial drug regulatory departments.

Product catalog: You can refer to the "Classification Catalog of Medical Devices" released by the National Medical Products Administration, which clearly lists the classification of various types of medical devices.




Precautions

The classification of medical devices may change with technological development and regulatory requirements. It is recommended to regularly review the latest version of the "Classification Catalogue of Medical Devices"

The registration certificate number for imported medical devices also follows similar rules, but will include the word "in" symbol

If you have any questions, you can log in to the official website of the National Medical Products Administration to inquire or consult professional institutions

Correctly identifying the category of medical devices is crucial for procurement, use, and regulation, and medical practitioners should master this basic skill.