MEDICAL DEVICE REGISTRATION AND APPROVAL IN Romania

MEDICAL DEVICE REGISTRATION AND APPROVAL IN Romania

General country-specific regulatory information is provided on this page for medical device registration and approval in Romania
Last update: December 2022

Medical Device Regulations and Classification in Romania

REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Romania, devices are regulated by the National Agency for Medicines and Medical Devices (NAMMD).

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.

TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

LICENSE VALIDITY: Licenses issued in the EU are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.

ADDITIONAL INFORMATION: On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

On market placement of the following types of medical devices, NAMMD registration of manufacturers, or their authorized representatives established in Romania, is mandatory: Class I medical devices, including sterile and / or measuring devices; Custom-made medical devices and custom-made active implantable medical devices; Systems and procedure packages & In-vitro diagnostic medical devices.

In Romania, NAMMD notification by manufacturers, their authorized representative, importers or distributors established in Romania/other Member State is mandatory when placing into service the following types of medical devices:

(a)          Class IIa, IIb and III medical devices;

(b)          In-vitro diagnostic medical devices covered by Annex II

(c)           In-vitro diagnostic medical devices for self-testing;

(d)          Active implantable medical devices.

 

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