Albania medical device registration timeline

Source-linked clocks

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

3 pathways3 of 3 clocks verifiedvalidity Not publishedMDSAP not acceptedreviewed 2026-08-30akbpm.gov.al

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I(Registration with ABPM) Class I registration reviewed within 5 working days of a complete application (Law No. 89/2018 on medical devices)	5 working days	1-3 months	—	Verified
Class II(Registration with ABPM) Class II registration reviewed within 30 working days of a complete application (Law No. 89/2018)	30 working days	2-4 months	—	Verified
Class III(Registration with ABPM) Class III registration reviewed within 30 working days of a complete application (Law No. 89/2018)	30 working days	3-5 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Albania Medical Device Registration Process

Step-by-step ABPM registration process. Total estimated timeline: 1-3 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by ABPM. Appoint a Albanian Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to ABPM including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

ABPM reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

5 working days

In-depth technical assessment of device safety and performance. ABPM may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, ABPM issues Albania market authorization certificate.

Summary: The Albania medical device registration process through Albanian Drugs and Medical Devices Agency (ABPM) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Law No. 89/2014 as amended is built on the EU framework, so the CE certificate and the technical documentation behind it are the substance of the ABPM dossier rather than an optional extra. ABPM publishes no shorter period for CE-marked devices.None published

FDA 510(k)/PMAUsable as supporting technical evidence. ABPM publishes no reduced period and no separate recognition route for US clearances.None published

Key requirements

Local Authorized Representative required for foreign manufacturers
Deficiencies must be remedied within 30 days; applications lapse otherwise
Amendment or cancellation of a registration decided within 30 working days
Manufacturing/importation licence (VKM No. 227/2022): completeness 25 days, review 5 days, decision 30 days
Clinical investigation authorisation within 60 days, with tacit approval if no decision issues

Primary regulator sources

akbpm.gov.al · Albania Law 89/2014 as amended by Law 21/2020 — registration clocks (Neni 13)

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against ABPM publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:albania:class-i