MEDICAL DEVICE REGISTRATION AND APPROVAL IN North Macedonia

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 Macedonia
Last update: December 2022

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:  BelarusBosnia & HerzegovinaIcelandLiechtensteinMoldovaNorwaySerbiaSwitzerlandTurkeyUkraine

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