NIFDC：Thirty products will be “kicked” out of the device list
On November 3, 2023, the NIFDC issued the Summary of the Third Medical Device Product Classification and Definition Results in 2023 (hereinafter referred to as the “Summary of results”), and announced a total of 261 medical device product classification and definition results from May 2023 to September 2023
01 Product classification definition results
This time, there are 261 medical device product classification definition results compiled from May 2023 to September 2023. Some of the lists are as follows:
| Medical Device Product Classification and Definition | Number | Medical device product classification |
| Products recommended to be managed as Class III medical devices | 71 | Ultrasonic soft tissue surgical knife head, disposable radiofrequency ablation needle, disposable hair follicle extraction kit, magnetic field control device, wound skin stretch closure device, chitosan-coated surgical suture, three-dimensional positioning intracardiac guidance kit, etc. |
| Products recommended to be managed as Class I medical devices | 108 | Disposable laser fiber, electrocautery instrument, prostate auxiliary puncture biopsy kit, disposable pulmonary surgical marking system, disposable endoscopic anastomosis clamp system, etc. |
| Products recommended to be managed as Class I medical devices | 27 | Retractor support arm adaptor clip, artificial valve protector, drill grinding handle, transparent medical film, etc. |
| Products not recommended to be regulated as medical devices | 30 | Autogenous dental bone powder, anti-adhesion solution, neck stoma bath accessory, endoscope transfer support, tooth curing gel, etc.
|
| Recommended products depending on specific circumstances | 10 | Portable eye chart, medical sodium hyaluronate eye care patch, recombinant collagen liquid film dressing, etc
|
| It is recommended that products not be managed separately as medical devices | 1 |
Accessory connector |
It should be noted that these classification definition results are based on existing regulatory policies, current classification catalogs, and information provided by applicants after research and synthesis.
#02.30 products may be “kicked” out of mechanical device names
There are a total of 30 products recommended not to be used as medical device management, including:
Software: psychological scale electronic software, hospital blood glucose management software, pain screening scale software, venous thrombosis scale software, enhanced examination information management system software, bedside detection data report printing software, adverse event scale electronic software, soft contact lens fitting information reference software, hypertension guide software; Oral: Autogenous bone powder, electric interdental brush, non-medical silicone rubber impression material, tooth curing gel; Surgical AIDS: surgical anti-adhesion solution, endoscope transfer stent, L-arabinose intestinal purging agent, small intestine stenosis detection capsule; Care categories: cervical stoma shower aids, nasal rinse waste collector, PICC catheter care package, defocused spectacle lenses, myopia prevention and control glasses; Scientific research: PIB bacteria identification kit unrelated to patient treatment: sample sorting system, sample storage system, anti-dropper, medical radiation protection spray, lead coat weight disperser; Other categories: octafluoropropane lipid microsphere injection activation device, ventilator exhaust gas filter.
The reasons are: the test results are only used for scientific research; it does not have data processing functions, and the data transmitted at the same time is not used as a basis for diagnosis and treatment; the software does not have the function of real-time monitoring of the test results and has no alarm function; it is not used for making dental restorations and medicine. It is used for medical purposes such as information reference; it has no impact on the patient’s examination and treatment; it does not have a physical effect; it does not have the function of a medical device, etc.
“Whether it has a direct or indirect effect on patient examination and treatment” has become an important basis for the adjustment of the classification of medical device in this Result Summary.
#03 The road for beautifying products through the “machine name” has been blocked
After NMPA releases the “Announcement on the Dynamic Adjustment Procedures for Medical Device Classification Catalog” in 2021, the “Medical Device Classification Catalog” can be proposed by relevant enterprises and institutions and adjusted as needed. In principle, the adjustment work should be done no less than once a year. This Result Summary is the further implementation of the adjustment work.
Products that have been registered before the regulations are promulgated have a five-year registration validity period. During this period, manufacturers can continue to produce and sell products, and they will not be subject to control after expiration.
The adjustments to the Result Summary are becoming more and more detailed, and they have had a subtle impact on the market. The way for companies to blindly put “mechanical device names” on their products to win the trust of the audience is no longer feasible.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
Source：NIFDC，Device Market
Translated & edited ： Bradyknow
