General country-specific regulatory information is provided on this page for medical device registration and approval in North Macedonia.
We review our Regulatory Information frequently; please check back often for updates
REGULATORY AUTHORITY: Medical devices are regulated by the Agency for Medicinal Products and Medical Devices | Ministry of Health.
CLASSIFICATION SYSTEM: Medical devices are classified according to EU risk-based model.
Medical Devices: Classes I, IIa, IIb and III.
IVD Devices: Same as the EU – List A or B, Self testing, all others
TIMEFRAME: The process takes approximately 90 days for devices.
Class I: The registration process takes about 90 days.
Class II: The registration process takes about 90 days.
Class III: The registration process takes about 90 days.
IVD Devices: The registration process takes about 90 days.
SPECIAL REQUIREMENTS:
Audits: An ISO 13485 Audit is required.
Technical Local Tests: There are no local testing requirements.
Clinical Evaluation/studies: There are no clinical studies requirements.
LOCAL FEES:
Application review fees: Fees depend on the number of devices, class, and if the devices hold CE certificates.
LICENSE VALIDITY: Devices with an EC Conformity certificate shall be valid until the date on which the conformity certificate expires.
LICENSE TRANSFER: Not applicable in Macedonia.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: A local authorized representative is required to register medical devices in Macedonia.
ADDITIONAL INFORMATION: The CE marking is mandatory, as is compliance with ISO standards.
Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine
For detailed device-specific compliance information for each market, including North Macedonia, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
