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Romania

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:    

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

Want to know more about this registration process?