Medical device registration certificate number format

Medical device registration certificate format by the State Food and Drug Administration unified development.

The registration certificate number is arranged as follows: × 1 mechanical note × 2 ××××3 × 4 × × 5 ××××6.

Which:

× 1 for the registration and approval of the department of the location of the abbreviation:

Domestic Class III medical devices, imports of Class II, Class III medical devices for the word "national";

domestic Class II medical devices for the registration and approval department of the location of the province, autonomous region, municipality directly under the Central Government abbreviation;

× 2 for the form of registration:

"Permit" word applies to the domestic medical devices;

"Into" word applies to imported medical devices;

××××3 is the year of first registration;

×4 is the product management category;

××5 is the product classification code;

××××6 is the first registration number.

Renewal of registration, ××××3 and ××××6 figures remain unchanged. Product management category adjustment, should be renumbered.

For example: the capsule system of whole-body heat therapy and its registration number: National Instruments note approved 20173264620

The meaning of its registration number is as follows:

1, "National Instruments" on behalf of the product in the territory of the third class of medical devices issued by the main body of the abbreviation.

2. "2017" is the year of the first registration of the product.

3, "No. 32646209" in the "3" that: the device is a Class III medical device;

4, "No. 3264620" in the "26" that: the device is a Class III medical device. "26" that: the device is: physical therapy and rehabilitation equipment; (see "State Food and Drug Administration Classification of Medical Devices Catalog").

5, "No. 3264620" in the "4620" that: the device's registration number 4620.

Attachment: "State Food and Drug Administration Classification Catalog of Medical Devices" (old)

Coding Device Category