New Medical Device Classification Catalogue was announced in draft on November 9, 2021, by the National Institutes for Food and Drug Control (NIFDC).
- 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 the original NIFDC announcement on the new medical device classification catalogue draft.
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.