A large number of medical device classification ushered in a major adjustment!
The third medical device classification and definition result in 2023 released, and a large number of medical devices delisted!
A large number of medical device classification ushered in a major adjustment!
The May 2023-September 2023 Medical Device Product Classification Definition results are 261 in total:
It is recommended to manage 71 products in accordance with Class III medical devices
108 products are recommended to be managed according to Class II medical devices.
It is recommended to manage 27 products according to Class I medical devices.
It is recommended to manage 27 products according to Class I medical devices.
It is recommended to define 14 products with management attributes according to the drug and equipment combination product judgment procedure, and 10 products are recommended to be determined according to specific circumstances.
1 product not recommended for separate management as a medical device.
832 medical devices, officially delisted
A total of 30 medical devices were removed this time, including hospital blood glucose management software, venous thrombosis scale software, bedside detection data report printing software, hypertension guide software and other management software.
In addition, from 2018 to September 2023, 5,221 medical device product classifications were changed, and 823 medical devices were removed and not managed as medical devices.
The Classification Catalogue of Medical Devices Meets the Latest Changes
In fact, as early as 2021, after the NMPA issued the “Announcement on the Work Procedure for Dynamic Adjustment of the Medical Device Classification Catalogue”, it was clear that the new version of the “Medical Device Classification Catalogue” should be adjusted according to needs, and the adjustment work should be no less than once a year in principle. In August this year, the new version of the “Medical Device Classification Catalogue” ushered in the first adjustment in 2023, involving a total of 58 items of the medical device classification catalogue. This is the fourth adjustment since its implementation.
From the point of view of the content of this adjustment, the adjustment range is wide and the impact is significant!
01 Wide adjustment range
A total of 15 subdivisions have been adjusted, with a total of 16 adjustments, of which the most adjusted content is passive implant devices.
| Categories involved in adjustments |
| 01 Active surgical instruments |
| 02 Passive surgical instruments |
| 03 Neurological and cardiovascular surgery |
| 04 Bone surgery set |
| 06 Medical imaging instrument |
| 07 Medical examination and monitoring |
| 09 Physiotherapy apparatus |
| 10 Blood transfusion dialysis and extracorporeal circulation instruments |
| 13 Passive implantable devices |
| 14 Injecting care and protective equipment |
| 16 Ophthalmological instruments |
| 17 Dental instruments |
| 18 Assisted reproduction and contraceptive devices in obstetrics and gynecology |
| 21 Medical software |
| 22 Clinical testing instrument |
Upgrades (4 items)：One item Class II medical devices has been upgraded to Class III medical devices ：（01-01-03 Ultrasonic knife head of soft tissue under the attachment of Ultrasonic surgery equipment）；Three items of Class I medical devices have been upgraded to Class II medical devices: All are 04 orthopedic surgical instruments，(04-14-06 Additive manufacturing class under positioning guided instrumentation, 04-16-03 additive manufacturing class under positioning, guiding, and measuring instrumentation, and 04-16-08 additive manufacturing class under positioning, guiding, and measuring instrumentation):
Downgrade (8 items): 5 items of Class III medical devices have been reduced to Class II medical devices: (01-10-02 separation control box, 03-13-13 guide sleeve, 03-13-16 guide wire, 04-17-01 non long-term implantation of expandable body under vertebral body forming equipment, 09-07-03 microwave treatment equipment not used for tumors); Three items of Class II medical devices have been downgraded to Class I medical devices: (06-05-06 anti-scattering filter grid, 06-05-07 X-ray photography cassette, 22-15-03 automatic sampling system)
02 Soft tissue ultrasonic knife head, breast rotary cutting product management category strengthened
Ultrasound knife and breast rotary biopsy system are widely used in clinical practice, and two important adjustments have been made this time:
（01-01-03）Soft tissue ultrasonic knife head class under ultrasonic surgical equipment has been upgraded from Class II medical devices to Class III medical devices.
01-10-06 breast rotary biopsy system and accessories have been added to the original five secondary categories of 01-10 other surgical equipment, which are managed according to three types of instruments.
And it is required that from January 1, 2026, such products shall not be produced, imported, or sold without obtaining a Class III medical device registration certificate in accordance with the law.
03 Third class medical devices have added a number of second-class classification entries.
This adjustment have also added 6 secondary classification items, all managed according to Class III devices. Respectively:
01-10-06 Breast rotary biopsy system and accessories
03-13-27cerebral thrombus removal device
03-13-28 Atrial septal puncture sheath
10-07-02 Mechanical perfusion and transport equipment for isolated organs
13-07-09 Auricular clamp
16-07-17 Artificial cornea
In addition, the description and use of absorbable nail stapler have been added under the existing secondary classification catalogue 02-13-01 stapler (with nail), which are managed according to Class III equipment.
The dynamic adjustment mechanism of the medical device classification catalog will directly relate to the way of listing medical device products, supervision methods, etc., and will also have a profound impact on the future layout of the market.
On the one hand, once the product classification is downgraded, the third class is reduced to the second class, the product does not need to go to the NMPA registration, directly in the provincial MMPA can be carried out; The second class is reduced to A class, and the enterprise product does not need to be registered, as long as the record can be filed.
On the other hand, in the supervision of medical devices, once the classification is upgraded from class I to class II, and a class II to a class III, it will usher in stricter supervision over the whole life cycle from production to circulation and use, and relevant medical equipment enterprises need to be prepared in advanc
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：Medical Device Distributors Alliance, NMPA
Translated & edited ： Bradyknow
