Overview of the National Agency for Medicines and Medical Devices (AKBPM) and Medical Device Regulation in Albania

National Agency for Medicines and Medical Devices (AKBPM) - Overview

The National Agency for Medicines and Medical Devices (AKBPM) (Agjencia Kombëtare e Barnave dhe Pajisjeve Mjekësore) is the specialized state regulatory institution under the Ministry of Health and Social Protection of the Republic of Albania. AKBPM is tasked with protecting public health by ensuring that all pharmaceuticals and medical devices marketed within Albania meet stringent safety, efficacy, and quality standards.

Key Roles and Responsibilities

AKBPM manages the comprehensive lifecycle and distribution of medical devices through several core regulatory capabilities:

• National Registration: Mandates that all medical devices (Class I, IIa, IIb, and III) and in vitro diagnostic medical devices (IVDs) must be officially registered in the National Register of Medical Devices (Regjistri i pajisjeve Mjekësore) before they can be legally placed on the Albanian market.
• CE Mark Recognition: In alignment with European Union requirements, Albania relies on regulatory recognition and requires a valid CE mark for medical devices entering the country, removing the need for a separate, full local technical assessment.
• Economic Operator Licensing: Regulates the legal entities involved in the supply chain. Manufacturers, local authorized representatives, and wholesalers must obtain proper market authorization and licensing from the authorities to trade or import medical equipment.
• Market Surveillance and Inspection: Conducts inspections and audits of wholesale operators and healthcare providers to ensure compliance with technical file certifications, proper storage, distribution protocols, and mandatory Albanian language labeling.
• Vigilance System: Acts as the central node for tracking and evaluating adverse events, manufacturing defects, and medical device malfunctions, cooperating with international safety networks to execute necessary recalls or corrective actions.

Regulatory Framework

The legal basis for AKBPM's oversight includes:

• Law No. 89/2014 "On Medical Devices": Establishes the foundational regulatory rules for the manufacture, import, registration, and surveillance of medical devices.
• Law No. 21/2020 (Amending acts): Progressively updates the national execution standards.
• Progressive harmonization with the European Union's Medical Device Regulation (MDR) - Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) - Regulation (EU) 2017/746.