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 updated on November 24th, 2021.
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.
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