Comparison essential requirements EU compared to those of MDSAP countries

[KarlHeinz]

Hello,

I am looking for a comparison of the essential requirements according to 93/42/EEC with the essential requirements of all MDSAP-countries.
Does anyone have a corresponding comparison?

Are there essential requirements for medical devices in the USA? If so, where are they defined?

Thanks a lot in advance!

 

[kreid]

Australia, Canada, Brazil and Japan have ERs or equivalent, I do not think the US has any.

For Oz = essential-principles-checklist-medical-devices

Canada = §10-20 of SOR-98-282

Japan and Brazil = Brazil and Japan - Essential requirements

Sorry, I can only attach one link, so Google the others

 

[Sturmer1982]

Hi Karl, I have seen an MDD essential requirements matrix that incorporates MDSAP country ERs. Though I only saw it on an auditor's screen - since not been able to find it. The chap said it was available via GHTF/IMDRF website, though this is not the case as I have thoroughly searched it. Have you been able to locate such a comparative document?

 

[kreid]

I think you you go to the documents I listed in my earlier post, you should be able to build a matrix yourself