General country-specific regulatory information is provided on this page. Become a LICENSALE.COM
user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.
Medical devices are regulated by the Medicines and Medical Devices Agency of the Republic of Moldova.
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.
Licenses issued in Moldova expire after five years.
An authorized representative is required.
Last updated on March 17 2015.
Interested in obtaining fast market approval for your medical device or IVD in Moldova? REQUEST A FREE QUOTE>