Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

There are registration requirements: General points

 You can split other regulated markets into the following: ● Accept CE mark DoC (or top 5) (plus CFS) – Albania requires a CE marked product plus language ● Accept CE data plus other requirements ● Requirements vary (eg East African countries)  Other items often required

● Letter of Authorisation ● Distribution agreement

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Other considerations

 Regulator overload ● E.g Malaysia

● Proprietary Information ● E.g quantities of materials use range or note that this is proprietary.  Regulatory Information ● Changes can happen quickly!

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