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. 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 |
| 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 |
| 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 dateWhat 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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