Medical Device Registration in Romania

Ministry of Health    

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 of Medical Devices 

Class I, IIa, IIb and III

Registration Process

1. Determine the device classification

2. Appoint an Authorized Representative and Notified Body

3. The medical devices must be registered in the NAMMD database

4. For class, I, custom-made and System packs – NAMMD registration should be made by the manufacturer or authorized representative

5. 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    

1. Application Form

2. CE certificate

3. Declaration of Conformity

4. Technical File

5. QMS Certificate

6. Labels, IFU

7. Letter of Authorization for Authorized Representative

8. Conformity Assessment Report from Notified Body

Post-Market Surveillance 

Adverse event report,

1. Serious public health threats – 2 day

2. Death or serious health deterioration – 10 days

3. 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