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:    

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