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Albania medical device registration timeline

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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 2026-08-25
Class / pathwayReview clockPlanning totalWith prior approvalProvenance
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 days1-3 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 days2-4 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 days3-5 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)Technical documentation and QMS evidence reuse1-3 months
FDA 510(k)/PMASubmission content reuse as reference evidence
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
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Source-linked review clocks verified against ABPM publications · full review 2026-08-25 · row IDs are stable — cite as registration-timeline:albania:class-i