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Medical Device Registration and Approval in North Macedonia
General country-specific regulatory information is provided on this page for medical device registration and approval in North Macedonia.
Last updated on November 22nd, 2021.
Medical Device Regulations and Classification in North Macedonia
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.
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