Medical Device Regulations in South Africa - Company makes thousands of Products

K

karen12

Hello,

I am preparing the documents for the company registration in South Africa since it is due by Jan. 31st, 2017. For the company registration, I was asked to provide all product list (each item list, with dental products, it is over thousands of product) with classification and its justification. However, normally in the company registration, you do not provide a full list of products but rather provide the family or group of the medical devices because the product registration will be done anyway later on.

I wonder how other companies prepare the documents for the new regulation.

Thanks!

Best,
Karen
 

Ronen E

Problem Solver
Moderator
Hi Karen,

Are you / the company based in SA?
What is your reference? Is it an official regulation / guidance, or a requirement relayed by another party?

Ronen.
 
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