MEDICAL DEVICE REGISTRATION IN ROMANIA
How OMC Medical can assist you with the process
- Act as your Romanian AR
- Help you with the Romanian registration by filling in the form and registering the medical device with the NAMMD authorities.
- 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:
- 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 referred to in Article 29 of Government Decision no. 54/2009;
- In-vitro diagnostic medical devices.
Data to be communicated to NAMMD:
- Notification Identification data
- Manufacturer Identification data
- Identification data of the authorized representative
- Medical device identification data
- Attached documents
Who should make this communication:
- Authorised representatives