🇦🇱 Albania medical device regulatory data

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 they will trade online; sale criteria are set by order of the minister responsible for health; failure to give the information is fined 200,000 lekë.

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 functions or features the device does not actually have; creates a false impression regarding treatment, diagnosis, functions or features; fails to inform the user or patient of a possible risk linked to use per the indication; or suggests uses other than those for which conformity assessment was obtained; violation is fined 200,000 lekë.

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 wholesaler is found to have been registered in breach of the law; (c) by order of the minister if the device is found to present a risk to the health or safety of patients, users or other persons; cancellation is effected within 30 days.

The device registration certificate (classes II and III) is valid for 5 years from the date of issuance.

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 and adverse-event reporting; it is subordinate to the minister responsible for health.

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 of risky devices on AKBPM proposal, and may authorize placing devices into service for special cases by special order.

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 in the register (if the approved change requires amendment of the registration decision) or refuses it depending on its type, within 30 days of receipt of the change documentation; implemented via e-Albania service No. 15129 (30 working days, free of charge).

In a conflict between the manufacturer and the approved (notified) body over application of the classification rules, the matter is referred to the minister responsible for health for decision.

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; clinical data may be based on existing scientific literature (demonstrating equivalence of the device), a critical evaluation of all clinical investigations carried out, or a combined critical assessment of both.

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 complete documentation and approval of the ethics committee; the minister grants or refuses within 60 days of receipt of the request and documentation; silence within the 60-day period counts as authorization granted; the ethics committee may propose to the minister revocation, suspension/termination of the investigation, or modification of any of its aspects.

Since Law 21/2020, specified products without an intended medical purpose are regulated as devices, including products introduced into the body to modify anatomy (except tattoo/piercing products), subcutaneous dermal/mucosal filling substances, liposuction/lipolysis/lipoplasty devices, intense electromagnetic-radiation skin devices (laser, IPL for skin renewal, tattoo or hair removal) and transcranial brain-stimulation devices.

'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 of pharmacological, immunological or metabolic means, intended for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury, investigation, replacement or modification of anatomy or a physiological process, or control of conception. Accessories (aksesor), in vitro diagnostic devices (pajisje mjekësore e diagnostikimit in vitro), self-test devices, active devices, active implantable devices and custom-made devices (pajisje me porosi) are separately defined; accessories are treated as devices.

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 as that device.

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 with data specific to the device classification and/or the CE certificate; (d) for custom-made and clinical-investigation devices, the declaration per Annex VIII of VKM 731/2015; (e) proof of the 500 lekë application fee paid at a second-tier bank. The form must be completed in Albanian and collects the customs nomenclature code, GMDN or UMDN code, device category, description/intended use, manufacturer and model, notified-body name/number, CE certificate number, link to the certificate on the official company or notified-body website, issue/expiry dates and the standards met; for class I devices, the Declaration of Conformity plus link and standards list.

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 holding the manufacturer's authorization; the wholesale trader performs import and export.

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 for its obligations within the territory of Albania.

All subjects placing class II and III devices on the market must appoint a person responsible for medical devices (person përgjegjës) holding a degree in law, biomedical/clinical engineering, electronic/chemical/physical/mechanical/electrical engineering, general medicine, dentistry, pharmacy or similar medical sciences.

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 updates; AKBPM sends the device register and monthly updates (by the 20th of each month) to Customs.

Entities importing class II and III devices already registered in the National Register must submit an electronic self-declaration within 10 days of release for free circulation of each registered device, stating imported quantity, series/lot and expiry dates; implemented through e-Albania service No. 15366 (free of charge); failure to declare is fined 100,000 lekë.

Domestic manufacture of devices requires a licence: application via the National Business Center; conditions include self-declaration of essential requirements and safety, dedicated production premises of at least 100 m2 plus at least 50 m2 for labelling/storage/distribution, a responsible person for the production line holding a second-cycle degree in biomedical/clinical/electronic/electrical/chemical/physical/mechanical engineering or medicine/dentistry/pharmacy with at least 3 years' experience; verification by physical inspection within 25 days, recommendation within 5 days, publication of the minister's decision within 30 days; the licence has no expiry.

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 + 1 year; class IIa: second-cycle degree + 1 year; class IIb/III/IVD/AIMD: second-cycle degree + 3 years), premises of at least 100 m2 (reception/sale, storage, recalled-products areas) and internal rules on storage conditions; application via the National Business Center; physical-inspection verification within 25 days, recommendation to the minister within 5 days, minister's decision published in the National Register of Licences within 30 days; the licence has no expiry date; appeal per Article 30 of Law 10081/2009.

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 patient per point 13 of Annex I of the technical rule must be in Albanian, whether the device is intended for professional or other use.

Labels must contain the manufacturer's name or trade name and address; for devices imported into Albania the label, outer packaging or instructions for use must also carry the name and address of the responsible person, the manufacturer's authorized representative established in Albania, or the importer in Albania.

Instructions for use (instruksione për përdorim) are not required for class I and class II devices.

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 (EU) 2017/745 (MDR). Three Council-of-Ministers technical rules implement the EU directives: VKM No. 508, 10.6.2015 (active implantable devices), VKM No. 731, 2.9.2015 (essential requirements, conformity, classification, CE of general devices) and VKM No. 189, 9.3.2016 (IVD devices).

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 device manufacturers and wholesalers are set by VKM No. 227, 13.4.2022.

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 guarantee quality and functioning, per definitions in the order of the minister responsible for health.

Current official submission channels are the e-Albania government portal electronic services: 'Aplikim për regjistrim pajisje mjekësore' (No. 15128; business identification required), 'Aplikim për ndryshim regjistrimi' (No. 15129), 'Aplikim për anullim regjistrimi' (No. 15130) and 'Autodeklarimi i importit për pajisje mjekësore' (No. 15366); the registration form is annexed to Order 360/2016 and class I applications are made in electronic form to AKBPM.

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 VII self-declaration for class I); AKBPM device inspectors inspect the manufacturer's quality assurance system and may order device tests, take samples and order proper labelling.

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 to failure to meet essential requirements, incorrect application of standards, or deficiencies in the standards themselves); the competent authority must require the manufacturer or its representative to take all corrective actions to bring the device into compliance, to restrict its availability on the market, to retrieve or withdraw it within a defined reasonable period communicated to the manufacturer/representative; non-compliance with such requirements is fined 1,000,000 lekë, and retail sale of unregistered devices 200,000 lekë.

Custom-made devices and clinical-investigation devices must be registered before being put into use and are exempt from CE marking, filing instead the special declaration per Annex VIII of VKM 731/2015; a single group registration is allowed for devices of the same manufacturer placed on the market by the same wholesaler when covered by the same conformity certificate.

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 application is filed by the manufacturer, the manufacturer's representative in Albania, or a wholesale trader holding the manufacturer's authorization, and AKBPM issues a registration certificate. For class I, any subject placing the devices on the market applies electronically and AKBPM notifies the subject electronically of registration within 5 working days.

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 again for the same device for each import. Domestic manufacturers apply within 15 days of CE certificate issuance (Order 360 point 5).

Under the original Order 360/2016 point 4, the application was filed with AKBPM within 15 working days starting from the date of customs clearance of the devices.

If a registration, amendment or cancellation application is incomplete, AKBPM invites the applicant in writing to remedy the deficiencies and submit the required data and documents within 30 days of receipt of the application; under Article 15(2) that 30-day period does not run until the applicant provides a verbal or written explanation; under Order 734 point 11 (2018) the request is refused if the documentation is not completed within the 30 days.

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 followed, provided use is absolutely necessary for the protection of public health (Art. 17(4)); (2) the minister may, by special authorization order, allow the putting into service of medical devices for special cases defined by his order (amended Art. 13(8)). Custom-made devices are exempt from CE marking and follow the Annex VIII declaration procedure.

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 licensing decisions are appealable under Article 30 of Law No. 10081/2009 on licences, authorizations and permits; appeals against measures under the law follow the inspection legislation.

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 additional documents to be completed, issuance of the registration certificate, or the official justification for non-issuance of the requested document.

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 customs nomenclature code and the GMDN or UMDN nomenclature code for each device; AKBPM publishes the device register as open data and shares it with Customs.

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 device's characteristics and/or performance, and any inadequacy of the labelling or instructions for use, that led or could lead to the death of a patient or user or to serious deterioration of their health; (b) any technical or medical reason relating to device characteristics or performance leading to systematic withdrawal from the market by the manufacturer of devices of the same type. AKBPM records and evaluates the information and notifies the responsible structure, which ensures the manufacturer or its Albanian representative is informed; the reporting procedure and format are set by order of the minister responsible for health.