MEDICAL DEVICE REGISTRATION AND APPROVAL IN Moldova

MEDICAL DEVICE REGISTRATION AND APPROVAL IN Moldova

General country-specific regulatory information is provided on this page for medical device registration and approval in Moldova
Last update: December 2022

Medical Device Regulations and Classification in Moldova

REGULATORY AUTHORITY: Medical devices are regulated by the Medicines and Medical Devices Agency of the Republic of Moldova.

CLASSIFICATION SYSTEM: Devices are classified according to the risk-based EU model of Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The approval process takes 45 days for Class I devices, and 90 days for all other classes of devices.

LICENSE VALIDITY: Licenses issued in Moldova expire after five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

 

 

Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Norway, Serbia, Switzerland, Turkey, Ukraine

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