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Regulatory and registration
Registration without the guesswork
We prepare, file and hold registrations with the national regulator, so your product is legally on the market before the first shipment.
Scope
What we handle
A
Medical devices
Registration of medical devices with MALMED, with classification support and local representation.
B
Cosmetics and dermocosmetics
Product notification, review of safety documentation and label compliance.
C
OTC and supplements
The correct registration or notification route, depending on the product status.
Process
How a registration runs
Dossier review
We check what you have against local requirements and list the gaps.
Localisation
Labels, leaflets and declarations are prepared in Macedonian.
Submission
We file with the regulator and handle every follow-up question.
Approval and holding
We hold the registration and keep it current through its lifecycle.