Malawi MACRA concluded its consultation for new type approval and fees regulation

on Sept 10th 2021, MACRA concluded its public consultation process and issued a feedback on comments its received from stakeholders as well as a draft regulation has been published.

The main points are as follow:

1- Macra sets a 45 days to process the approval

2- Macra will issue identification mark for labelling of approved devices. It will be possible to use e-identification or affix the identification on the packaging under certain conditions

3- The fees are increased and depending on the category of the device.

The regulations, once promulgated by the Minister, shall become effective after its publication in the official gazette.

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