On November 9, 2021, the NIFDC (National Institutes for Food and Drug Control) announced the draft classification catalogue for medical devices.
Highlights
- The following products were added:
- 02-11-03 expander
- 13-11-04 tissue-induced implant devices
- 13-11-05 containing chitin intraarticular fluid
- 17-06-03 Metal and ceramic denture materials for additive manufacturing
- 17-08-05 implant AIDS
- The description of the following products were modified:
- 03-05-02 hemostatic clip
- 08-05-15 oxygen inhaler
- 17-10-06 tooth bleaching material
- 18-06-03 screen contraceptive device
- 22-02-01 biochemical analysis instrument
- 22-06-05 Microbial mass spectrometry identification instrument
- 22-10-04 liquid chromatography analysis instrument
- 04-05-01 probe changed from Class III to Class II
- Revised the intended use of 04-12-01 orthopedic dynamic surgical equipment
- Revised secondary product category, product description, expected use, product name example for 06-01-06 mobile C-arm X-ray machine
- Modified expected use, product name examples of 07-04-01 patient monitoring equipment
- Modified Sample names of 09-07-02 radiofrequency superficial therapy device, 13-05-02 Calcium salt bone Implant, 13-09-01 Plastic implant, 14-01-06, 22-04-09 biochemical immunoassay devices;
- Modified the product description and management category of 16-04-01 ophthalmic laser diagnostic equipment;
- Amended secondary product category, product description, intended use, sample product name, management category of 17-03-08 Tooth bleaching equipment
- Modified the first class product category of 18-06 pregnancy control device
- Modified product description and product name examples of 22-04-05 immunoblotting instrument
- Modified product description, intended use, product name examples of 22-05-03 nucleic acid amplification analyzer, 22-07-02 Image scanning instrument, 22-10-03 Mass spectrometry Detection system, 09-07-01 RF hyperthermia device, 13-09-02 Plastic injection fillers
- Modified secondary product category, product description, intended use, product name example of 22-15-02 counter board
Read our blog post about the In Vitro Diagnostic Reagents Classification Rules that was published by the NMPA as a standalone document for the first time.
By Alice Liu and Jacky Li. Contact Cisema if you would like to learn more.
