Medical Device Definitions outside GHTF (Global Harmonization Task Force)

I have an view that non-medicinal consumer health products are more likely to be 'borderline' products (across e.g. cosmetics, articles, biocides) than health products intended to be used by professionals. In regions such as the EU, one can always go back to primary legislative definitions and guidance documents, but what about regions outside the GHTF domain? For example, in Russia, the registration process is reasonably well defined, if tortuous, but is there a functional definition of what a medical device is in Russia, or is this based on market precedent or local negotiation?

vikingwill said:

I have an view that non-medicinal consumer health products are more likely to be 'borderline' products (across e.g. cosmetics, articles, biocides) than health products intended to be used by professionals. In regions such as the EU, one can always go back to primary legislative definitions and guidance documents, but what about regions outside the GHTF domain? For example, in Russia, the registration process is reasonably well defined, if tortuous, but is there a functional definition of what a medical device is in Russia, or is this based on market precedent or local negotiation?

Click to expand...

Hello and welcome to the cove

Are you after Russia in particular, or was it just an example? I would say that outside the GHTF domain every territory has to be considered on its own, as there is a significant variance in availability of information.

Regarding Russia, there's some valuable information available in English on the web. Have you already researched it? If you did, and still confused, then I'd recommend contacting a Russian-speaking specialist, who could look into the full extent of regulatory documentation to help you find the answer. Please PM me if you're interested in locating such a consultant.

Cheers,
Ronen.

Thanks for the feedback; I've been researching the regulatory environment in Russia, but it does seem to be somewhat 'fluid' at this time - partly based on an absence (as far as I see) of a definition of what constitutes a medical device which leads to apparent arbitrary classifications of devices by different government agencies, and uncertainty for manufacturers of consumer medical devices which may have characteristics which straddle regulatory categories. Additionally, the formation of the customs union between the Russian Federation, Kazakhstan and Belarus will invariably change the regulatory requirements and processes.