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
- Guideline for orthopedic surgical devices
- Guideline for blood transfusion, dialysis and cardiopulmonary bypass devices
- Guideline for passive surgical devices
- Guideline for Passive implantable devices
- Guideline for medical device-disinfection and sterilization equipment
- Guideline for active implantable devices
- Guideline for medical imaging devices
- Guideline for stomatological devices
- Guideline for traditional Chinese medicine devices
- Guideline for radiotherapy devices
- Guideline for medical software
- Guideline for medical rehabilitation devices
- Guideline for respiratory, anesthesiological and first aid devices
- Guideline for obstetrics and gynecology, assisted reproduction and contraceptive devices
- Guideline for neural and cardiovascular surgical devices
- 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.
