Medical Device Registration in
Ministry of Health
Medical Device Regulation
Law No. 89/2014 – On Medical Equipment
Law No. 21/2020 – For some additions and amendments to Law No. 89/2014
Class I, IIa, IIb and III
– Devices must be registered in the National Register of Medical Devices maintained by the Control Agency of Drugs & Medical Devices.
– Registration applications can be filled by manufacturers, ARs or wholesalers.
– Products with CE Mark can bypass the Conformity Assessment Procedure
Declaration of Conformity.
Conformity Assessment certification
Adverse Event reporting to Medical Device Management Sector. The medical care provider sends the report within 4 weeks from observation.
Class I – 5 working days
Class II & III – 30 working days.
Class I – Lifetime, until they comply
Class IIa, IIb, III – 5 years
Labels in the Albanian language.
IFUs not required for Class I & II devices.