• EnglishEnglish
    • Deutsch Deutsch
    • Italiano Italiano
    • Français Français
    • 日本語 日本語
    • 한국어 한국어

CISEMA - China Zertifizierung, Einkauf und Qualitätssicherung

  • Services
    • NMPA Registration – Medical Devices and IVDs
    • NMPA Registration & DMF – Pharmaceuticals
    • NMPA Registration – Cosmetics
    • NMPA Registration – Health Food
    • CML (China Manufacture Licence) – Pressure vessels
    • CCC (China Compulsory Certification) – Industrial and consumer goods
    • Others
      • Sourcing and Quality Control
      • Logistics and Customs Support
      • Sales Support
  • Events
    • Trade Fairs & Conferences
    • Seminars
    • Webinars
  • News & Knowledge
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • Pharmaceuticals & DMF
      • CCC
      • Pressure Vessels
    • Whitepapers
    • FAQ – NMPA Registration – Medical Devices and IVDs
    • Newsletter Sign Up
    • Others
      • Publications
      • Online Shop
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • Newsletter Sign Up
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • China Medical Device Naming Rules Updated

China Medical Device Naming Rules Updated

medical device naming rules china
Tuesday, 21 June 2022 / Published in Medical Device, News, NMPA Registration in China

China Medical Device Naming Rules Updated

Medical device naming rules for China have been updated. On June 2, 2022, China’s National Medical Product Administration (NMPA) issued 6 guidelines for establishing generic names of medical devices. This brings the total number of published guidelines for generic names of medical devices to 22.

List of medical device generic names guidelines

1. Guideline for Active Surgical Devices

It is applicable to active medical devices for surgical treatment purposes including but not limited to:

  • ultrasound
  • laser
  • high frequency / radio frequency
  • microwave
  • freezing
  • shock wave
  • surgical navigation and control system
  • surgical lighting equipment, etc.

2. Guideline for Physical Therapy Devices

It is applicable to physiotherapy device products, mainly including but not limited to:

  • treatment devices using electrical, thermal, light, force, magnetic, acoustic and other physical factors
  • excluding surgical instruments and other specialty-specific physiotherapy instruments.

3. Guideline for patient-bearing devices

It is applicable to carrier devices with a patient carrying function and transport function, excluding specialty devices with load function, such as carrier devices in stomatology, obstetrics and gynaecology, orthopaedics, and medical rehabilitation devices.

4. Guideline for Ophthalmic devices

It is applicable to ophthalmic devices, including all kinds of ophthalmic devices and related auxiliary devices used in ophthalmic diagnosis, surgery, treatment and protection.

5. Guideline for infusion, nursing and protective devices

Due to the large differences in the technical characteristics and expected use of the products of injection devices and the nursing/protective device, the principle of formulating the core word and the characteristic word cannot be unified. The Guideline therefore divided them into two parts:

  • Part 1 Infusion devices, applicable to infusion devices, including but not limited to:
    • injection devices,
    • puncture devices,
    • infusion devices (including intravascular infusion devices and non-intravascular infusion devices),
    • hemostatic devices,
    • non-intravascular tubes and in vitro devices used as a set.
  • Part 2 Nursing and protective devices, applicable to nursing and protective medical devices.

6. Guideline for clinical laboratory devices

It is appliable to equipment, instruments, auxiliary equipment and appliances, and medical cryogenic storage equipment used in clinical laboratories applicable to the management of medical devices, excluding in vitro diagnostic reagents.

Principles of Medical Device Naming Rules in China

Composition structure of medical device generic names

The generic name of a medical device should be composed of

  • feature word 1 (if any)
  • + feature word 2 (if any)
  • + feature word 3 (if any)
  • + core word

A core word is a general expression of medical devices that have the same or similar technical principle, structural composition, or intended purpose.

A feature word is a description of specific attributes such as structural characteristics, technical characteristics, forms of use, forms of provision, parts of use or objects of action, applicable groups of people or scenarios, intended uses or purposes, etc.

Core word and feature word selection

Core words and feature words should be selected from the glossary listed at the end of the Guidelines according to the true attributes and characteristics of the product. Terms may be supplemented or adjusted for terms that are not included in the glossary, where new products or original products have new feature items that need to be reflected, or where new terms need to be added to a feature item.

Core words should be selected under the category item to best suit the product attributes – please note that the use of core words is compulsory. Feature words should be selected according to the relevant characteristics of the product, and a term that matches it should be selected under each feature word in the glossary. If a feature word is not listed in the glossary, then the applicant may choose a corresponding professional term according to the actual situation of the product.

Here is an example of the generic name of a medical laser fiber product:

Core word

Feature word 1

Feature word 2

Generic name

Form of usage

Form of provision

Medical laser fiber

Single use

Reusable (default)

Sterile

Non-sterile

(Default)

√

√

√

Single-use medical laser fiber

The 16 previously issued guidelines for medical device generic names in China

  1. Guideline for orthopedic surgical devices
  2. Guideline for blood transfusion, dialysis and cardiopulmonary bypass devices
  3. Guideline for passive surgical devices
  4. Guideline for Passive implantable devices
  5. Guideline for medical device-disinfection and sterilization equipment
  6. Guideline for active implantable devices
  7. Guideline for medical imaging devices
  8. Guideline for stomatological devices
  9. Guideline for traditional Chinese medicine devices
  10. Guideline for radiotherapy devices
  11. Guideline for medical software
  12. Guideline for medical rehabilitation devices
  13. Guideline for respiratory, anesthesiological and first aid devices
  14. Guideline for obstetrics and gynecology, assisted reproduction and contraceptive devices
  15. Guideline for neural and cardiovascular surgical devices
  16. Guideline for medical examination and monitoring devices

History of medical device naming rules in China

With the promulgation of the Regulations on the Supervision and Administration of Medical Devices (Revised Edition) in 2014, the concept of medical device generic names was officially proposed. In December 2015, the Rule for the Naming of Generic Names of Medical Devices was issued and came into effect in April 2016, setting out the basic requirements for generic names. Later the NMPA issued a Guideline for the Naming of Generic Names of Medical Devices in 2019, which is the basic convention on medical device naming rules in China and the preparation of naming guidelines for specific medical device product categories/sectors.

As of June 2 2022, there are a total of 22 product-specific guidelines that have been published and more for other devices are underway.

By Grace and Victoria. If you would like to learn more about how the medical device naming rules apply to your product or our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, industrial or consumer goods, contact Cisema.

GET IN TOUCH

🌐 Send us your enquiry
📚 Request our whitepapers
📣 Sign up for our newsletter

What you can read next

Simplifications of Clinical Studies
New Regulatory Controls to Support the CSAR Including Animal Testing Exemptions
ICH Q13
ICH Q13 guidelines on continuous manufacturing in pharmaceuticals in China – draft for comments

Search

Categories

  • Fairs & Events
  • News
    • CCC
    • CEL
    • CML, SELO
    • Medical Devices Listing in Hong Kong
    • NMPA Registration in China
      • Cosmetics
      • Health Food
      • Medical Device
      • Pharmaceuticals & DMF
    • RoHS
    • Voluntary Product Certification
  • Publications
  • Seminars
  • Uncategorized
  • Webinars

Recent Posts

  • GB9706 standards for medical electrical equipment

    GB9706 standards for medical electrical equipment – implementation details clarified

    GB9706 standards are important reference guidel...
  • Microbial limits for non-sterile chemical drugs

    Microbial limits for non-sterile chemical drugs, API and excipients – new guidelines issued

    Microbial limits for non-sterile chemical drugs...
  • Medical Device Supplementary Notice Period

    China’s Medical Device Supplementary Notice Period reverts to a one-year period

    China’s Medical Device Supplementary Notice Per...
  • Dental adhesive products registration review guidelines

    Dental adhesive products registration review guidelines issued by the CMDE

    Dental adhesive products registration review gu...
  • China’s Toothpaste Supervision & Administration Regulation

    China’s New Toothpaste Supervision & Administration Regulation: A brief guide

    China’s Toothpaste Supervision & Administra...

Archive

Cisema

With twelve locations and over ninety highly qualified employees, Cisema can offer you optimal support in China.

Services

  • Certification
  • Sourcing and Quality Control
  • Logistics and Customs Support
  • Sales Support

Dialogue

  • Contact us
  • Newsletter Signup
  • Events
  • News & Knowledge
  • Partners

Company

  • GTC
  • Privacy Statement
  • Legal Notice
  • About us
  • Locations
  • GET SOCIAL

© 2021 Cisema. All rights reserved.

TOP