Regulatory Authority:  National Agency for Drugs and Medical Devices (AKBPM)

Link for MoH:http://akbpm.gov.al/ 

Local Listing or Registration: Yes, Local listing is required.

Local Regulation: Law No. 89/2014 On Medical Devices

Overview of Albania Medical Device Regulations

 In July 2014, the Albanian government ratified a new legislation on medical devices, aligning with European Union (EU) standards. Subsequently, in August 2016, specific provisions related to the registration and labelling of medical equipment, as outlined in the 2014 law, came into effect. This legislation mandates CE marking for all medical devices entering Albania. Manufacturers, whether domestic or foreign, along with registered wholesalers and retailers, must seek authorizations from the Ministry of Health (MoH) to operate in the market.

The law necessitates the registration of all medical equipment in the National Register of Medical Equipment, overseen by the National Agency of Drug Control and Medical Equipment. Moreover, compliance requires Albanian language labels on all medical devices. However, the limited number of local companies in the market influences the distribution of medical equipment.

Medical Devices Classes

• I class
• IIa class medical devices,
• IIb class medical devices,
• III class medical devices,

Medical Device Registration in Albania

Devices falling in the above classes has to be registered at the National Register of Medical Devices before placing in Albanian market.

Who should do the Registration?

• Manufacturer,
• Manufacturer’s representative in the Republic of Albania,
• Wholesaler(Authorized by Manufacturer).

When to make this Communication?

When a medical device is put into service into the French territory

Registration Certificate Validity

5 years from the date of its issuance.