The NMPA published twelve guidelines on December 9, 2020. Among all the guidelines, seven of them are for IVD products and five are for nomenclature. Among these, they have introduced important adjustments to the contents of the Classification Catalogue of Medical Devices for 28 classifications of medical devices. This includes management of 15 classifications of medical devices and catalogue contents of 13 classifications of medical devices.

Implementation requirements have been described as below:

  1. 1. Since the date of this Notice, the drug supervision and administration department will accept the application for registration and filing of medical devices according to the adjusted classifications.
  2. 2. For medical devices that have been accepted but not yet completed the registration approval (including first registration and renewal registration), the drug supervision and administration department shall continue to review and approve in accordance with the original acceptance classification. If the registration is approved, the certificate shall be issued, and the adjusted product management classification shall be indicated in the remark column of the certificate.
  3. 3. For registered medical devices, if the management category is adjusted from Class III to Class II (from Class II to Class I), the medical device registration certificate shall remain valid within the period of validity.

In case of renewal, the registrant shall apply to the relevant drug supervision and administration department for renewal, in accordance with the changed category 6 months, prior to the expiration of validity period of the registration certificate. If the registration is approved, the medical device registration certificate shall be issued according to the adjusted product management classification. Before the expiration of the registration certificate, the registrant may apply to the related drug supervision and administration department for product filing, and if the filing information meet the requirements, the drug supervision and administration department shall make the filing certificate in accordance with the relevant requirements and release the information in the filing information form on its website.

4. Where any registration change occurs within the validity of medical device registration certificate, the applicant shall apply for the registration change to the original registration department.

Summary of opinions on product management classification
adjustment of the Classification Catalogue of Medical Devices


Class I Product Classification

Class II Product Classification

Example of product name

Original management Classification

Management classification after adjustment


01-Active surgical devices

09-Active equipment for endoscopic surgery

01- Active equipment for endoscopic surgery

Shaver system


06-Medical imaging devices

01-Diagnostic X-ray machine

02-Urinary X-ray machine

Urinary X-ray machine


06- Medical imaging devices

01- Diagnostic X-ray machine

04-Oral X-ray machine

 Oral panoramic X-ray machine


06- Medical imaging devices

14- Medical endoscopes

01-Optical endoscope

 laparoscopic, arthroscopic


06- Medical imaging devices

14- Medical endoscopes

03- Electronic endoscope

 Electronic laparoscopy, Electronic laryngoscopy


06- Medical imaging devices

16- Endoscope aids

01Endoscopic insertion shape observation system

Endoscopic insertion shape observation system


16- Ophthalmology devices

04- Ophthalmology measurement diagnostic equipment and appliances




17-Dental equipment

02-Oral inspection equipment

03-Oral imaging aids

 Dental optical duster


17- Dental equipment

03-Oral treatment equipment

07-Planting equipment

 Implant locator


18 Obstetrics and Gynecology, assisted reproduction and contraceptive devices

03-Diagnostic equipment for obstetrics and gynecology

03 Gynaecological endoscope

Electronic vaginal endoscope


22- Clinical testing equipment

01- Hematological analysis equipment

07- Red blood cell setoe device

Fully automatic blood sink analyzer



22- Clinical testing equipment

06- Microbiological analysis equipment

01-Microbiological turbidimetric instrument

Microbiological turbidimetric instrument



22- Clinical testing equipment

07- Scan image analysis system

01- Medical microscope

Biological microscope



22 Clinical testing equipment

11- Sampling equipment and appliances

07- Blood collection card

Newborn blood collection card



22-Clinical testing equipment

15- Inspection and other ancillary equipment

02- The counting board

Blood cell counting board



Announcement of NMPA on the Adjustment of Parts of the Medical Device Classification Directory (No.147,2020)