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
