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.
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.
Last updated on March 17 2015.
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