Two Nomenclature Guidelines For Medical Devices Issued By NMPA

On August 23, 2021, NMPA issued the Nomenclature Guidelines for Neurological and Cardiovascular Surgical Devices and the Nomenclature Guidelines for Medical Diagnostic and Monitoring Devices, so as to further standardize the generic names of medical devices and strengthen the life cycle management of medical devices.

Background

The concept of generic name of medical devices was formally put forward in the Regulations on the Supervision and Administration of Medical Devices revised in 2014. The Nomenclature Guidelines of Medical Devices implemented in 2016 put forward the basic requirements for the generic name of medical devices.

Nomenclature for Generic Names of Medical Devices

1. All medical devices sold and used within China shall use the generic names in accordance with the Guidelines.
2. The generic name of medical devices shall comply with the provisions of relevant national laws and regulations, which should be scientific and clear, and be consistent with the true attributes of the products.
3. The generic name of medical devices shall be in Chinese.
4.  The same generic name shall be used for the same kind of medical devices with the same or similar intended use and common technology.

The general name of medical devices consists of one core word and generally no more than three characteristic words. The core word is a general expression of medical devices with the same or similar technical principles, structural composition or expected purpose. Characteristic words refer to the description of specific attributes such as the use position, structural characteristics, technical characteristics or material composition of medical devices.

Standardizing the generic name of medical devices plays a very positive role in the supervision of medical devices. It not only helps to unify the evaluation and regulatory standards, but also avoids informal publicity by enterprises for commercial purposes. A compliant name is critical for the registration and circulation of products in the Chinese market. IMD has a lot of experience in product registration and naming. Do not be hesitate to contact us (info@inspirativemed.com) if you have any questions.