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

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.



Interested in obtaining fast market approval for your medical device or IVD in Macedonia? REQUEST A FREE QUOTE>

For more information on registration in Macedonia, check out the following articles on our blog:
Country at a Glance: Macedonia
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