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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Moldova, to expedite the preparation of your medical device or IVD registration application.

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.

Last updated on March 17 2015.

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