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.