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Medical Software Regulatory Requirements for South America and Middle East



With the changes to the MDD last year, medical software got a lot more guidance and attention in terms of regulatory requirements. However, in the cursory research that I have done into emerging markets this hasn't followed through in other countries.

I am looking for advice on whether a medical software product which is a clinical information system would require regulatory approval in the following countries. I should add that the company has recently attained ISO13485:2003 and has had the product CE certified as a Class 1 device in Europe (even though this wasn't necessary, it was done more for marketing purposes due to some of the national comments on such systems in Sweden).

From reading other threads, there doesn't seem to a lot of clarity on this area.

Do these countries actively consider such software as a medical device or is either software exempt or ignored?

Saudi Arabia

South Africa


I know it is a long list but any assistance would be appreciated.


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Hi All,

I would like to know if it is mandatory to register MD in chile or EC marking certificates are enough.

thanks !!!
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