Medical Device Registration and Approval in Macedonia

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

Medical Device Regulations and Classification in 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.

Last updated on March 29, 2019.

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