How OMC Medical can assist you with the process

  1. Act as your Romanian AR
  2. Help you with the Romanian registration by filling in the form and registering the medical device with the NAMMD authorities.
  3. Translate your documents to Romanian for submission.

Regulatory Authority: National Agency for Medicines and Medical Devices of Romania

Link for MoH: https://www.anm.ro/en/

Local Listing or Registration: Yes, Local listing is required.

Local regulation: Romanian law

Medical devices concerned:

  1. Class I medical devices, including sterile and / or measuring devices;
  2. Custom-made medical devices and custom-made active implantable medical devices;
  3. Systems and procedure packages referred to in Article 29 of Government Decision no. 54/2009;
  4. In-vitro diagnostic medical devices.

Data to be communicated to NAMMD:

  1. Notification Identification data
  2. Manufacturer Identification data
  3. Identification data of the authorized representative
  4. Medical device identification data
  5. Attached documents

Who should make this communication:

  1. Manufacturers
  2. Authorised representatives