Ministry of Health

Ministry of Health and Social Protection

Regulatory Authority

National Agency for Drugs and Medical Devices (AKBPM)

Medical Device Regulation

Law No. 89/2014 – On Medical Equipment

Law No. 21/2020 – For some additions and amendments to Law No. 89/2014

Official Language

Albanian

Classification

Class I, IIa, IIb and III

Registration Process

– 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

Documents Required

Declaration of Conformity.

Product Description

Technical File

Conformity Assessment certification

Post-market Requirements

Adverse Event reporting to Medical Device Management Sector. The medical care provider sends the report within 4 weeks from observation.

Applicable QMS

ISO 13485:2016

Registration Timeline

Class I – 5 working days

Class II & III – 30 working days.

Authorized Representative

Yes

License Validity

Class I – Lifetime, until they comply

Class IIa, IIb, III – 5 years

Special Notes

Labels in the Albanian language.

IFUs not required for Class I & II devices.