New List of Medical Device Harmonized Standards - MDD

[wrodnigg]

Today a new List of Harmonized Standards has been published.

[ScottK]

thanks wrodnigg, that might come in handy for me as we make some parts that are used in the in the medical gas industry.

[Al Rosen]

I'll attach the list.

[jkuil]

Up-to-date list of harmonised standards can be found here.

The FDA keeps a database of recognized stadards.

The Canadian list can be found here.

For the medical device company where I am working I maintain a list of applicable standards and inform functional area managers on changes or new standards. However, they are struggling with keeping the technical files up-to-date and assure that all products remain state of the art. Any suggestions, exemples of procedures from you folks. I have some ideas, but they like to benchmark.

[MIREGMGR]

Any similar info available for Asian countries?

The language barrier is tough for US suppliers into Asia--for me, anyway--when (sometimes, not always) regulatory and design/functionality guidance info is published only in the local language, and therefore is impossible for a non-local-language speaker to search for on websites, even though it's permissible to market devices that are labeled in English.

[jkuil]

Both China and Japan generate their own standards, based on international standards. Whereas in other regions standards are always voluntary, Japanese and Chinese standards are (partly) mandatory.

For china see their database of Chinese medical device industry standard (addition of /T means recommendation, without /T are mandatory standards).

For Japan see the JSA webstore.

For Australia the recognized standards are refrenced in the standards orders.