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.