January 10, 2020
On December 25, 2019, the NMPA issued the so-called "Guideline for General Naming Rules for Medical Devices" (hereafter simply referred to as the “Guideline”), which is based on the "Medical Device Common Name Naming Rules". The Guideline is formally implemented from now on, and is applicable to medical devices only, not including IVDs.
The Guideline entails the regulations concerning the application of the general names for medical devices, the structure and requirements of these names, the nomenclature, the descriptions of the common nomenclature, and examples. The general name for medical devices in China consists of a core word and not more than three characterizing “feature words”.
For example, implantable (feature word 1) + rechargeable (feature word 2) + spinal cord (feature word 3) + nerve stimulator (core word) → implantable rechargeable spinal nerve stimulator.
China, Guiding Principles,Naming Rules