Albania medical device regulations
Official sources linkedAKBPM rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Law No. 21/2020 | Amendments to the Albanian Medical Devices Law Ligj nr. 21/2020 amending Law 89/2014. Ingested Neni 1–21 of the amending law from the official AKBPM PDF. The text states the changes to Law 89/2014, including repeal of Neni 28. Approved 5 March 2020; promulgated by decree no. 11455 of 26 March 2020. | General | — | Official |
| Law No. 89/2014 | Law on Medical Devices Ligj nr. 89/2014 për pajisjet mjekësore. Ingested Kreu I–VIII and Neni 1–34 from the official AKBPM PDF. Approved 17 July 2014; promulgated by decree no. 8670 of 1 August 2014. Later amended by Law 21/2020; this expression is the original 2014 text. | General | — | Official |
| Order No. 734/2018 | Amendments to device registration procedure (Order 734 of 18 October 2018) Complete two-page official AKBPM-hosted original, with uncropped original page images and the qualified native PDF search layer. Amends Order 360/2016; the original distinguishes immediate entry into force from effects beginning 1 November 2018. Native text omits or garbles handwriting, so original images govern. Later amendments and current consolidated effect have not been established. | Registration | — | Official |
| Decision No. 227/2022 | Licensing of medical-device manufacturers and wholesalers (Decision 227 of 13 April 2022) Complete five-page official QKB-hosted decision, with uncropped original page images and qualified native PDF search text. Covers device manufacturer and wholesaler licensing; section III explicitly includes IVD-related responsible-person qualifications. This is the published decision, not a verified current consolidated expression. | Registration | — | Official |
| Decisions 731/2015, 508/2015 and 189/2016 | Medical Device, Active Implantable and IVD Technical Rules AKBPM technical rules covering essential requirements, conformity assessment, classification, and CE marking for general medical devices, active implantables, and IVDs. | Classification | — | Official |
Exports carry source + retrieval dateChanges after registration in Albania
Source-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.
Does changing a device brand name or logo require an update?
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
How do I update a manufacturer's name without changing the legal entity?
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
What changes when the manufacturer's office address changes?
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Does a catalogue or reference code change affect registration or UDI?
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
Can a registration transfer to a different legal entity?
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Can several changes be filed together?
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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