AKBPM · Europe

Albania medical device regulatory resources

Every Albania dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

12,609 registration records10 free resources24/25 requirements covered3 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official AKBPM device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official AKBPM regulations and guidance documents.

AI medical device classifier

Describe your device and get a preliminary AKBPM risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Albania requirements.

AI similar registered product finder

Describe a device and find comparable products in the AKBPM registration database.

Medical device regulation news

Follow recent AKBPM / Ministry of Health policy, guidance, safety, and compliance updates.

Government registration fees

Review current AKBPM medical-device fee evidence and official tariff availability.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare official and realistic ABPM approval times by device class and pathway.

Structured regulatory requirements

Explore all 42 source-linked facts →

24 of 25 research dimensions currently covered · 11 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified

Competent authority: AKBPM (Agjencia Kombëtare e Barnave dhe Pajisjeve Mjekësore, National Agency of Medicines and Medical Devices) is the specialized institution for registration of medical devices, inspection…
Minister of Health licensing and risk powers: The minister responsible for health takes the final decision on licences for domestic manufacture and wholesale trading of devices, may suspend or revoke them, orders withdrawal/restriction…

2 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Primary legislation: Law No. 89/2014 'Për pajisjet mjekësore' (On Medical Devices), as amended by Law No. 21/2020, is the primary statute; Law 21/2020 states it was drafted in partial alignment with Regulation…
Registration orders and licensing decision: Registration procedure is set by Order of the Minister of Health No. 360, 22.08.2016 (procedures, documentation and costs), as amended by Order No. 734, 18.10.2018; licensing conditions for…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Medical device definition and related terms: 'Medical device' (pajisje mjekësore) is any instrument, apparatus, material or other item, used alone or in combination, whose intended action on/in the human body is achieved with the aid…
Software as device: Standalone software is considered an active medical device under the classification rules; software that drives a device or influences its use is automatically classified in the same class…

3 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

General-device classes I, II and III (Law 21/2020 merged former Classes IIa/IIb into Class II).: Class I, Class II, Class III

1 maintained scheme · 1 related fact

Checked 2026-08-25

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D05

Registration pathways

Verified

Registration route by class: All devices placed on the market must be registered in the National Register of Medical Devices (Regjistri Kombëtar i Pajisjeve Mjekësore) kept by AKBPM. For classes II and III the applicat…
Application before first customs clearance: The registration application is filed with AKBPM before the first customs clearance of the device; after registration the subject has no obligation to obtain the registration certificate ag…

4 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Accepted foreign conformity evidence: Conformity of a device with the essential requirements is confirmed by issuance of the CE marking document or, equally, by an FDA certification document; for CE the manufacturer follows the…
Harmonized standards presumption: A device conforming to all applicable Albanian harmonized standards (reference list published in the Official Gazette) is presumed to conform to the essential requirements; if it conforms o…

2 source-linked facts

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Local applicant roles: For classes II and III the local applicant is the manufacturer established in Albania, the foreign manufacturer's representative established in Albania, or a wholesale trader of devices hol…
Manufacturer's representative: A 'representative of the device manufacturer' is any natural or legal person established in Albania, clearly designated in writing by the manufacturer, who acts in place of the manufacturer…

3 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Wholesale licence: Wholesale of devices is carried out only by licensed legal persons. Licensing conditions (VKM 227/2022): an employed responsible person qualified by risk class (class I: first cycle degree…
Import performed by wholesalers: Import and export of devices are performed by the authorized/licensed wholesale traders; the Ministry of Health sends the General Directorate of Customs the list of wholesale traders and up…

4 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Registration dossier and form data: Registration dossier (Order 734 point 5, reformulating Order 360 point 16): (a) request letter to AKBPM; (b) application form; (c) photocopy of the manufacturer's Declaration of Conformity…

1 source-linked fact

Checked 2026-08-25

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D10

Official forms & portals

Verified

Official forms and portals: Current official submission channels are the e Albania government portal electronic services: 'Aplikim për regjistrim pajisje mjekësore' (No. 15128; business identification required), 'Apli…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Albanian-language labelling: Every device placed on the market and put into service must bear the label in the Albanian language, presented in visible and legible form; information made available to the user and patien…
IFU exemption for classes I and II: Instructions for use (instruksione për përdorim) are not required for class I and class II devices.

3 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

QMS/certificate scope accepted and inspection: Registration evidence includes the foreign CE or FDA certificate, with conformity routes for CE set by VKM 731 point 8 (e.g. Annex II full quality assurance for classes III and IIb, Annex V…

1 source-linked fact

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

Medical electrical and EMC evidence: Electrical safety
AKEP radio equipment conformity notification/recognition: Wireless / radio
Radiation and legal-metrology authorization: Radiation

3 maintained overlays

Checked 2026-08-29

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D14

Fees

Verified

Medical-device registration application: ALL 500

1 maintained fee line

Checked 2026-08-25

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D15

Review clocks

Verified

Class I · Registration with ABPM: 5 working days
Class II · Registration with ABPM: 30 working days
Class III · Registration with ABPM: 30 working days

3 maintained pathways · 1 related fact

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

Registration certificate validity: The device registration certificate (classes II and III) is valid for 5 years from the date of issuance.
Cancellation of registration: AKBPM cancels a device registration from the National Register: (a) at the request of the certificate holder; (b) ex officio if the manufacturer, the manufacturer's representative or the wh…

2 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Change notification and amendment: After registration, the certificate holder must notify AKBPM of any change to the documentation on which registration was based and file an amendment request; AKBPM registers the amendment…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

No UDI; nomenclature-based national register: The opened legislation contains no UDI requirement: the National Register of Medical Devices assigns an identification number to each operator, and the registration form requires the custom…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical investigation authorization: Clinical investigations require authorization by the minister responsible for health, granted to the manufacturer or its representative that has registered activity in Albania, based on com…
Clinical evaluation requirements: Confirmation of conformity under normal conditions of use and assessment of undesirable side effects must be supported by clinical data, particularly for implantable and class III devices;…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Special access derogations: Two derogations exist: (1) the minister may, on a reasoned request, allow the placing on the market and use of particular devices for which the conformity assessment procedures were not fol…

1 source-linked fact

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Lifecycle controls (no PMS plan duty): The opened legislation imposes no PMS plan, PSUR, PMCF/PMPF or trend reporting duty; instead, devices are subject during their life cycle to periodic controls by notified bodies to guarante…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Adverse event reporting to AKBPM: Any natural or legal person placing devices on the market or putting them into service must inform AKBPM of every adverse event concerning: (a) any malfunction or deterioration of the devic…

1 source-linked fact

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Withdrawal, restriction and corrective action: AKBPM, by order of the minister responsible for health, withdraws from the market or restricts the use of a device that may endanger the health or safety of patients, users or others (due t…

1 source-linked fact

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Advertising (publiciteti) rules: Advertising rules for devices are adopted by Council of Ministers decision, consistent with the device's characteristics summary; advertising must not contain information that: describes fu…
Internet sales notification: Wholesale and retail traders may buy and sell devices over the internet under the law and sub legal acts, but must communicate in advance to AKBPM the necessary information on the devices t…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Written appeal to the Ministry of Health: The applicant may file a written appeal with the Ministry of Health against refusal of registration, amendment or cancellation in the National Register of Medical Devices; ministerial licen…
Submission communications during review: After an online application, responsible officers verify the documentation and the applicant is notified by e mail and in the 'Dokumentet e mia' section of their e Albania account about add…

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (1 lines) →

AKBPM registration fees in ALL · reviewed 2026-08-25

Fee line	Amount	Provenance
Medical-device registration application	ALL 500	Verified

Registration timeline

Full registration timeline →

Albanian Drugs and Medical Devices Agency (ABPM) review clocks and planning ranges · 3-class (I, II, III) — Law No. 89/2018 classification

Class / pathway	Review clock	Planning total	Provenance
Class I(Registration with ABPM)	5 working days	1-3 months	Verified
Class II(Registration with ABPM)	30 working days	2-4 months	Verified
Class III(Registration with ABPM)	30 working days	3-5 months	Verified