Medical Device Registration in
Romania
Ministry of Health:
Regulatory Authority:
National Agency for Medicines and Medical Devices of Romania (NAMMD)
Medical Device Regulation:
EU MDR 2017/745
EU IVDR 2017/746
Official Language:
Romanian
Classification:
Class I, IIa, IIb and III
Registration Process:
- Determine the device classification
- Appoint an Authorized Representative and Notified Body
- The medical devices must be registered in the NAMMD database
- For class, I, custom-made and System packs – NAMMD registration should be made by the manufacturer or authorized representative
- For Class II, III, IVDs and active implantable – NAMMD notification should be submitted within 3 months of the medical device putting into service.
Documents Required:
- Application Form
- CE certificate
- Declaration of Conformity
- Technical File
- QMS Certificate
- Labels, IFU
- Letter of Authorization for Authorized Representative
- Conformity Assessment Report from Notified Body
Post-market surveillance:
Adverse event report,
- Serious public health threats – 2 day
- Death or serious health deterioration – 10 days
- Other serious incidents – 15 days
Applicable QMS:
ISO 13485
Authorized Representative:
Yes
License Validity:
- Years
Special Notes:
Record of medical devices in the national database is free of charge