The State Food and Drug Administration (SFDA) in China recently drafted the “Principles of Medical Device Nomenclature” to standardize medical device names. Medical device nomenclature is currently unregulated, which has led to confusion and misrepresentation. Medical devices which are essentially the same may have completely different names, while different medical devices might use the same name. Also, some medical device companies choose names which exaggerate their product’s benefits. By establishing guidelines on nomenclature, the SFDA hopes to eliminate confusion and exaggeration.
The SFDA has already established a medical device category directory to help medical device companies in naming their products. In addition to this directory, medical device companies would have to follow national or industrial standards in naming their devices. However, if the device is highly innovative and does not fall into an existing category, the naming is to be based on the device’s structure and basic function.
Among other stipulations, the same product produced by one manufacturer must maintain the same name. Names must also be in Chinese, though an English name can be included if there is one.
These guidelines are to apply to medical devices marketed in China, including foreign imported devices. Medical device distributors would also have a responsibility to follow these rules, even if they do not manufacture the product themselves.
The SFDA is currently seeking public comments on this proposed draft until December 10, 2006. When the guidelines are made official, applicants still waiting for approval may be required to fill out additional forms to ensure compliance.