Medical Device Registration in


Medical Device Registration in Albania

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



Class I, IIa, IIb and III

Medical Device Registration in Albania

– 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 by Albanian Health Authorities

– 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


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.

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