Are IVDs regulated in Mozambique?

Fro, October 2020 the Mozambican government requires all companies importing health products to either register their company to get a Pharmaceutical license or use any of the already listed companies that have that Pharmaceutical license. The “Portuguese guideline” which is a Pharma guideline is the only one they have and Medical devices and IVDs will fall under it as they do not have resources to implement IVD and Medical Devices specific guidelines.

One of the main requirements for the application of this Pharmaceutical license is to have a Technical Director/Medical Doctor that is local to be the “Local Representative/Responsible Person. This license is used at customs and the Technical Director is responsible for Post Market requirements.

This Article Also Answers the Following Questions :

  • What should I do to register a product in Mozambique?
  • Regulations Mozambique

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