AKBPM · structured requirements

🇦🇱 Albania IVD regulatory data

Explore the IVD requirements currently available for Albania, organized by topic and linked to official sources.

1 facts1 dimensions1 official sourceslatest verification 2026-09-15

Changes after registration

Common questions about changing a registered IVD in Albania. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Albania approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Albania (3 records)

AlbaniaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Usable as supporting technical evidence. ABPM publishes no reduced period and no separate recognition route for US clearances.
Timeline Savings: None published

Albania Law 89/2014 as amended by Law 21/2020 — registration clocks (Neni 13)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

AlbaniaEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority: CE Mark (EU MDR)
Accepted: Yes
Benefit: 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.
Timeline Savings: None published

Albania Law 89/2014 as amended by Law 21/2020 — registration clocks (Neni 13)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

AlbaniaNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference

Pending verification

Statement: Albanian device registration with AKBPM rests on CE conformity: Law 21/2020 amending Law 89/2014 provides that conformity with the essential requirements is confirmed by a CE marking document or, equally, an FDA certification document (held fact), and the AKBPM registration dossier under Order 360/2016 as amended by Order 734/2018 requires a copy of the declaration of conformity and/or CE certificate issued under technical rules VKM 731/2015, 508/2015 and 189/2016. No provision refers to China, NMPA or certificates from the country of manufacture, so an NMPA registration has no documentary or procedural role.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: albania
China Classes In Scope: NMPA Class II/III certificates and Class I filings; target all Albanian classes
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Applicant must be a wholesale trader holding a Ministry of Health wholesale authorisation.
Dossier: self-declaration form, declaration of conformity and/or CE certificate, list of standards for the CE certificate, manufacturer/distributor authorisation, fee.
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2018-10-18

Source passage: Pas tërheqjes së Autorizimit, aplikanti plotëson dosjen për aplikim bazuar në Urdhrin nr. 360 date 22.08.2016 ndryshuar në Urdhrin nr. 734 date 18/10/2018, me dokumentacionin si vijon: [...] Fotokopje e deklaratës së konformitetit dhe/ose CE (bazuar në VKM nr. 731; 508; 189)

Related structured datasets

Classification systems · 1 record

Open General-device classes I, II and III (Law 21/2020 merged former Classes IIa/IIb into Class II). →

albania:medical-device

Jurisdiction Id

albania

Domains

medical-device
ivd

Name

General-device classes I, II and III (Law 21/2020 merged former Classes IIa/IIb into Class II).

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
ii
Label
Class II
Normalized Risk Level
medium
Id
iii
Label
Class III
Normalized Risk Level
highest

Regulator

AKBPM

Official Domains

akbpm.gov.al

Source Status

official-source-verified

Notes

Law 89/2014 originally used EU-style classes I, IIa, IIb, III; Law 21/2020 (Neni 3) replaced "klasat II a dhe II b" with "klasën II" throughout, in force from 2020.
VKM 731/2015 (point 7.1 and Annex IX) originally transposed Directive 93/42/EEC classification with classes I, IIa, IIb, III and the full 18-rule scheme; re-confirmed 2026-08-25.
Conflict to be aware of: VKM 227/2022 (wholesaler licensing) still uses risk classes I, IIa, IIb, III plus IVD and AIMD categories for responsible-person qualification levels, so the legacy four-class nomenclature persists in licensing practice alongside the statutory three-class scheme (qkb.gov.al).

Source Title

Ligj Nr. 21/2020, Neni 3 — amendment to Law 89/2014 “Për Pajisjet Mjekësore”

Source Url

https://akbpm.gov.al/wp-content/uploads/2020/05/Per-disa-shtesa-dhe-ndryshime-ne-ligjin-nr.-89.2014-Per-Pajisjet-Mjekesore.pdf

Verified On

2026-08-25

Source Supports

class-axis

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Albania registration →

Country

Albania

Jurisdiction Id

albania

Country Code

Flag

🇦🇱

Regulator

Albanian Drugs and Medical Devices Agency

Regulator Abbrev

AKBPM

Region

europe

Tier

Risk Classification

3-class (I, II, III) — Law No. 89/2018

Classes

Id
class-i
Class Name
Class I
Risk Level
low
Pathway
Registration with ABPM
Official Timeline
Min
5
Max
5
Unit
working-days
Realistic Timeline
Min
1
Max
3
Unit
months
Notes
Class I registration reviewed within 5 working days of a complete application (Law No. 89/2018 on medical devices)
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
Albania Law 89/2014 as amended by Law 21/2020 — registration clocks (Neni 13)
Url
https://akbpm.gov.al/wp-content/uploads/2020/05/Per-disa-shtesa-dhe-ndryshime-ne-ligjin-nr.-89.2014-Per-Pajisjet-Mjekesore.pdf
Accessed Date
2026-08-25
Id
class-ii
Class Name
Class II
Risk Level
medium
Pathway
Registration with ABPM
Official Timeline
Min
30
Max
30
Unit
working-days
Realistic Timeline
Min
2
Max
4
Unit
months
Notes
Class II registration reviewed within 30 working days of a complete application (Law No. 89/2018)
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
Albania Law 89/2014 as amended by Law 21/2020 — registration clocks (Neni 13)
Url
https://akbpm.gov.al/wp-content/uploads/2020/05/Per-disa-shtesa-dhe-ndryshime-ne-ligjin-nr.-89.2014-Per-Pajisjet-Mjekesore.pdf
Accessed Date
2026-08-25
Id
class-iii
Class Name
Class III
Risk Level
high
Pathway
Registration with ABPM
Official Timeline
Min
30
Max
30
Unit
working-days
Realistic Timeline
Min
3
Max
5
Unit
months
Notes
Class III registration reviewed within 30 working days of a complete application (Law No. 89/2018)
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
Albania Law 89/2014 as amended by Law 21/2020 — registration clocks (Neni 13)
Url
https://akbpm.gov.al/wp-content/uploads/2020/05/Per-disa-shtesa-dhe-ndryshime-ne-ligjin-nr.-89.2014-Per-Pajisjet-Mjekesore.pdf
Accessed Date
2026-08-25

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

Prior Approvals

Authority
CE Mark (EU MDR)
Accepted
Yes
Benefit
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.
Timeline Savings
None published
Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
Usable as supporting technical evidence. ABPM publishes no reduced period and no separate recognition route for US clearances.
Timeline Savings
None published

Local Rep Required

Yes

Local Rep Name

Albanian Authorized Representative

Mdsap Accepted

Mdsap Benefit

Not accepted

Registration Validity

Not published

Verification Status

official-verified

Official Sources

Title
Albania Law 89/2014 as amended by Law 21/2020 — registration clocks (Neni 13)
Url
https://akbpm.gov.al/wp-content/uploads/2020/05/Per-disa-shtesa-dhe-ndryshime-ne-ligjin-nr.-89.2014-Per-Pajisjet-Mjekesore.pdf
Accessed Date
2026-08-25

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by AKBPM. Appoint a Albanian Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to AKBPM including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
AKBPM reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. AKBPM may issue questions.
Duration
5 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, AKBPM issues Albania market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Albania fees →

Jurisdiction Id

albania

Country

Albania

Country Code

Authority

AKBPM

Low Risk Local

Min: 500
Max: 500
Currency: ALL
Per Product: Yes

High Risk Local

Min: 500
Max: 500
Currency: ALL
Per Product: Yes

Details

Id
medical-device-registration-application
Item
Medical-device registration application
Currency
ALL
Amount Local
500
Amount Local Formatted
ALL 500
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://akbpm.gov.al/wp-content/uploads/2019/09/Urdher-Pajisjet-734.pdf
Source Title
AKBPM Order 734: amended medical-device registration procedure and application fee
Source Effective Date
2018-11-01
Verified On
2026-08-25

Notes

Order 734 amended point 16 of Order 360 and sets the application payment at ALL 500.
The current e-Albania medical-device registration service also publishes ALL 500.
Zero-fee events per e-Albania: registration amendment (service 15129), registration cancellation (service 15130), and import self-declaration (service 15366) are all "Pa pagesë" — only the initial registration application carries the ALL 500 fee.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
AKBPM Order 734: amended medical-device registration procedure and application fee
Url
https://akbpm.gov.al/wp-content/uploads/2019/09/Urdher-Pajisjet-734.pdf
Effective Date
2018-11-01
Accessed Date
2026-08-25
Title
e-Albania medical-device registration service
Url
https://e-albania.al/ServiceDetails/15128
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Albania certifications →

Slug

albania

Market

Albania

Confidence

low

Schemes

Id
medical-electrical-and-emc-evidence
Name
Medical electrical and EMC evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Registration relies on the foreign CE certificate (or FDA certification per Law 21/2020) plus the Declaration of Conformity; presumption of conformity via Albanian harmonized standards (VKM 731/2015 points 6.1-6.2) with conformity routes per class (point 8); the registration form must list the standards met, with the notified-body certificate number for CE-certified devices (Order 360/2016 form).
Source Binding
unresolved
Id
akep-radio-equipment-conformity-notification-recognition
Name
AKEP radio equipment conformity notification/recognition
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Equipment
Source Urls
https://akep.al/e-konformiteti/
Source Binding
candidate
Id
radiation-and-legal-metrology-authorization
Name
Radiation and legal-metrology authorization
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Product And Use Site
Note
Law 89/2014 Art. 7(2)-(3): devices emitting ionizing or non-ionizing radiation may be placed on the market only if they meet the radiation-protection legislation in force, and devices that are also machinery must additionally meet machinery safety requirements; AKBPM inspectors may order device tests and take samples (Art. 27(1)(c)/(ç)).
Source Urls
https://akbpm.gov.al/wp-content/uploads/2019/09/ligj2.pdf
Source Binding
reviewed

Official Sources

Authority
AKEP
Topic
radio equipment conformity and registration
Url
https://akep.al/e-konformiteti/
Authority
ISHMT
Topic
electromagnetic compatibility
Url
https://ishmt.gov.al/perputhshmeria-elektromagnetike/?lang=en
Authority
AKBPM
Topic
VKM 731/2015 CE assessment rules for medical devices
Url
https://akbpm.gov.al/wp-content/uploads/2019/09/Vendim-nr.-731-dt.-02.09.2015-per-vleresimin-e-CE-se-pajisjeve-mjekesore.pdf
Authority
AKBPM
Topic
Law 89/2014 radiation and machinery overlay, inspector testing powers
Url
https://akbpm.gov.al/wp-content/uploads/2019/09/ligj2.pdf
Authority
AKBPM
Topic
Order 360/2016 registration form standards list
Url
https://akbpm.gov.al/wp-content/uploads/2019/09/urdheri-360.pdf