On August 25, 2021, the NMPA (National Medical Products Administration) published (No.62-2021) the Guidelines for the Nomenclature of Neurological and Cardiovascular Surgical Instruments, and the Guidelines for Medical Diagnostic and Monitoring Instruments in China.
Highlights
- Both guidelines were formulated in accordance with the current Guidelines for the Nomenclature for Common Names of Medical Devices.
- The Chinese names of medical devices are formed in the combination of a maximum of three characteristics words and one core word.
- Core words are general expressions for medical instruments that have the same or similar technical principles, structural composition or intended purpose. For example: “Hemostatic Clamp”, “Catheter”, “Electrocardiogram machine”, etc.
- Characteristics words are descriptions of specific attributes such as the use of medical device parts, structural features, technical features or material composition. For example: “Microscopic”, “Heart”, “Single-use”, etc.
- Naming example of a medical diagnostic and monitoring device: Fixed (characteristics word) + Curve (characteristics word) + Diagnostic Catheter (core word) = 固定弯标测导管 (Fixed curve diagnostic catheter)
- Some characteristics words without appearing in the product names can still be understood for the same meaning by default. For instance, pulse oximetry sensors are intended to be either “single-use” or “reusable”, while “single-use pulse oximetry sensors” is clear and commonly used for this indication, “pulse oximetry sensors” will be understood as a “reusable” product even without the word showing in the product name.
There has been a continuous focus on the supply of high-end, high-cost medical devices in China, and Neurological and Cardiovascular Surgical Instruments have been one of the top five class II and III product groups of foreign origin to be registered in 2019 and 2020. We expect further announcements will be made in future to strengthen the regulatory framework of product groups focused in China.
By Colleen Xu and Jacky Li. Contact Cisema if you would like to learn more.
