Medical Device Registration and Approval in Macedonia

General country-specific regulatory information is provided on this page for medical device registration and approval in Macedonia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Macedonia, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Macedonia

REGULATORY AUTHORITY: Medical devices are regulated by the Ministry of Health (MOH).

CLASSIFICATION SYSTEM: Medical devices are classified according to EU risk-based model into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The process takes approximately 90-180 days for all classes of devices.

LICENSE VALIDITY: The length of license validity depends on the class of the device: three years for Class I and IIa devices, two years for Class IIb devices, and one year for Class III and IV devices. Licenses for AIMDs are valid for one year, and licenses for IVDs range from one to three years depending on classification.

AUTHORIZED REPRESENTATIVE: A local authorized representative is required to register medical devices in Macedonia.

Last updated on January 29 2015.

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