Moldova – Medical Device Registration Guideline

PURPOSE

The purpose of this document is to provide orientation to the industry professionals in regard to regulatory requirements concerning market authorization of medical devices in Moldova. Furthermore, information provided might serve as starting point at investigating regulatory requirements for new product development planning. The information has been collected by reviewing the relevant laws and ordinances as well as in direct communication with officials of national bodies and trusted user’s experiences. The guideline has been also created for purpose of providing summary of regulatory information at single location in order to save time and effort of its users.

Regulamedica® is a consulting project for “unknown user” and does not act on behalf of any National Agency, therefore formal information concerning registration of medical device is only provided by relevant national authority sources of information.

SCOPE

The document provides regulatory information for registration of medical device (as defined by 93/42/EEC MDD and National Law) at Moldavian National Agency, in purpose of its placement to Moldavian market. The Guideline is applicable to medical devices with and without CE marking.

OTHER

Guidelines are continuously accessible online thru Regulamedica® user panel, also mobile compatible.