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ANPP · structured requirements

🇩🇿 Algeria IVD regulatory data

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

3 facts3 dimensions2 official sourceslatest verification 2026-09-16

Changes after registration

Explore questions and sources →

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

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Publicity of medical devices is expressly named among the agency's activities

advertising.publicity-of-devices-is-an-agency-activity
Fact-level verified

Algerian statute names the publicity of medical devices expressly, alongside the publicity of pharmaceutical products, among the activities of the National Agency for Pharmaceutical Products (ANPP) from which the agency derives revenue: its resources include the fees (redevances) arising from 'l'enregistrement, l'homologation et la publicité des produits pharmaceutiques et des dispositifs médicaux, à usage de la médecine humaine', in accordance with the legislation and regulation in force. Device publicity is thereby placed on the same statutory footing as device registration and homologation as a regulated, fee-bearing agency activity.

Effective from 2018-07-29

Source is French; quoted verbatim with an English translation. The article is part of the chapter on the National Agency for Pharmaceutical Products. Its scope is what makes it device evidence: the statute distinguishes 'produits pharmaceutiques' from 'dispositifs médicaux' and names both in the same clause on publicity, so a device-specific advertising activity exists in Algerian law. The article states that publicity is a fee-bearing ANPP activity; it does not itself set out the publicity rules, and the substantive publicity provisions of Loi 18-11 are drafted for pharmaceutical products — see the unresolved note for D24.

Reliance & recognition

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

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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.

Algeria 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 Algeria (3 records)

AlgeriaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

Yes

Benefit

Usable as supporting technical evidence only, with no published reduction.

Timeline Savings

None published

Algeria décret exécutif n° 20-324 du 22 novembre 2020 — homologation: recevabilité 8 jours (Art. 22), avis de la commission 30 jours (Art. 27), décision 240 jours prorogeable de 90 jours (Art. 30), validité 5 ans (Art. 34)Algeria arrêté du 23 juin 2021 (JO 62) — homologation des DM fabriqués localement et destinés exclusivement à l'exportation: décision 90 jours prorogeable de 30 jours (Art. 9)Algeria arrêté du 23 juin 2021 (JO 62) — modification de la décision d'homologation: décision 90 jours prorogeable de 30 jours (Art. 12), demande corrigée traitée en 30 jours (Art. 15)Algeria arrêté (JO 62 du 15 août 2021) pris en application du décret exécutif n° 21-82 — agrément des établissements pharmaceutiques de fabrication: avis de la commission technique 8 jours, décision ministérielle 30 jours, levée des réserves 60 jours

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

AlgeriaNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence
Pending verification
Statement

Algeria's device regime (Décret exécutif n° 20-324 of 22 November 2020 and its implementing arrêté of 10 May 2021) requires an imported device to be documented by the competent authority of the country of origin: a certificate of free sale or equivalent and the origin-country marketing authorisation in the homologation dossier, and ongoing reporting of any prohibition or restriction imposed by the origin-country health authority, while the homologation decision itself rests on ANPP's own commission evaluation. For a China-manufactured device the NMPA registration certificate (or Class I filing) is the origin-country authorisation this evidence rests on, but neither text names NMPA or any foreign authority whose approval abridges the Algerian review.

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

algeria

China Classes In Scope

All device classes (I-III) subject to ANPP homologation

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Art. 19 (20-324): dossier must contain administrative, technical (design to finished product) and scientific/clinical data; composition fixed by arrêté (arrêté 10 mai 2021 Art. 4: CLV or equivalent from the pharmaceutical regulatory authority showing registration and marketing in the country of origin, origin-country AMM, CPP where applicable, copies of other countries' authorisations)
  • Art. 36 (20-324): holder must immediately declare to ANPP any prohibition or restriction imposed by the competent health authority of the country of origin or any other country where the device is marketed
  • Homologation decision issued after opinion of the commission d'homologation; full national review, no abridged route by reference to a foreign approval
  • 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 2020-11-22

Source passage: Art. 19. — La demande d'homologation déposée auprès de l'agence nationale des produits pharmaceutiques doit être accompagnée d'un dossier technico-administratif comprenant les renseignements d'ordre : — administratif sur le dispositif médical et le demandeur ; — technique, de la conception du dispositif médical jusqu'au produit fini ; — scientifique et données cliniques, le cas échéant. [...] Art. 36. — durant la période de validité de la décision d'homologation, il est fait obligation au détenteur et/ou à l'exploitant de la décision d'homologation de déclarer immédiatement à l'agence nationale des produits pharmaceutiques : [...] — toute interdiction ou restriction imposées par l'autorité de santé compétente du pays d'origine ou de tout autre pays où le dispositif médical est commercialisé et toute autre information nouvelle qui pourrait influencer l'évaluation du rapport de sécurité du dispositif médical concerné.

AlgeriaEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority

CE Mark (EU MDR)

Accepted

Yes

Benefit

Usable as technical and QMS evidence in the dossier. Algeria requires its own registration decision and publishes no recognition route or origin-based reduction.

Timeline Savings

None published

Algeria décret exécutif n° 20-324 du 22 novembre 2020 — homologation: recevabilité 8 jours (Art. 22), avis de la commission 30 jours (Art. 27), décision 240 jours prorogeable de 90 jours (Art. 30), validité 5 ans (Art. 34)Algeria arrêté du 23 juin 2021 (JO 62) — homologation des DM fabriqués localement et destinés exclusivement à l'exportation: décision 90 jours prorogeable de 30 jours (Art. 9)Algeria arrêté du 23 juin 2021 (JO 62) — modification de la décision d'homologation: décision 90 jours prorogeable de 30 jours (Art. 12), demande corrigée traitée en 30 jours (Art. 15)Algeria arrêté (JO 62 du 15 août 2021) pris en application du décret exécutif n° 21-82 — agrément des établissements pharmaceutiques de fabrication: avis de la commission technique 8 jours, décision ministérielle 30 jours, levée des réserves 60 jours

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

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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The only statutory exceptional-use route is limited to unregistered medicines

special-access.temporary-authorisation-limited-to-unregistered-medicines
Fact-level verified

The one statutory exceptional-use instrument in Algerian health law is the autorisation temporaire d'utilisation (ATU): it may be delivered by the minister charged with health, after the opinion of the National Agency for Pharmaceutical Products (ANPP), for médicaments non enregistrés — unregistered medicines — when those medicines are prescribed in the treatment of serious diseases, where no equivalent treatment exists on national territory and where they present proven therapeutic utility. The ATU is therefore defined by reference to medicinal products, and Loi 18-11 defines médicament (Art. 208) separately from dispositif médical (Art. 212), so the route does not extend to medical devices. Its implementing modalities are fixed by regulation.

Conditions
  • The ATU is delivered by the minister charged with health, after the opinion of the National Agency for Pharmaceutical Products.
  • It is available for 'médicaments non enregistrés' prescribed for serious diseases with no equivalent treatment available on national territory and with proven therapeutic utility.
  • Implementing modalities are fixed by voie réglementaire.
  • Search result recorded with this fact: Décret exécutif n° 20-324 (the device homologation decree, arts. 1–46 read in full) contains no emergency, compassionate, custom-made, humanitarian or unregistered-import route for devices — the decree's only use of 'à titre exceptionnel' concerns the director general's extension of the ANPP's 240-day decision deadline (Art. 30), and the words 'dérogation' and 'humanitaire' do not occur in it.

Effective from 2018-07-29

Source is French; the passage is quoted verbatim below with an English translation. The Journal officiel is printed in two columns, so a linear text extraction interleaves the columns; the excerpt below was de-interleaved against a layout-preserving extraction of the same official PDF, which reproduces the article word for word as one column. This fact states the express statutory scope of the ATU (unregistered medicines); the negative finding for devices is a search result recorded in the conditions and is not put forward as an express statement of the instrument. A device-specific special-access route was searched for in Loi 18-11 (the words 'dérogation' and 'humanitaire' do not occur in it) and in the device homologation decree; none was found.

Related structured datasets

Classification systems · 0 records

No maintained record.

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 Algeria registration →
Country

Algeria

Jurisdiction Id

algeria

Country Code

DZ

Flag

🇩🇿

Regulator

National Agency for Pharmaceutical Products

Regulator Abbrev

ANPP

Region

africa

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — EU-aligned

Classes
  • Id

    homologation

    Class Name

    Medical-device homologation

    Pathway

    ANPP registration

    Official Timeline
    Min

    240

    Max

    330

    Unit

    days

    Realistic Timeline
    Min

    9

    Max

    14

    Unit

    months

    Notes
    • Décret exécutif 20-324 Art. 30: the ANPP must decide within 240 days from the date the file is ruled admissible under Art. 22, and the director general may exceptionally extend that by up to 90 days, which is where the 330-day upper bound comes from
    • The clock is suspended whenever complementary information is requested, and an application lapses outright if the applicant misses the deadline set for supplying it
    • The decree states one homologation clock and does not allocate separate clocks by risk class
    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    Algeria décret exécutif n° 20-324 du 22 novembre 2020 — homologation: recevabilité 8 jours (Art. 22), avis de la commission 30 jours (Art. 27), décision 240 jours prorogeable de 90 jours (Art. 30), validité 5 ans (Art. 34)

    Url

    https://www.miph.gov.dz/fr/wp-content/uploads/2021/06/05-Decret-executif-n%C2%B0-20-324-du-22-novembre-20-relatif-aux-modalites-dhomologation-des-dispositifs-medicaux.pdf

    Effective Date

    2020-11-22

    Accessed Date

    2026-08-30

  • Id

    export-only-homologation

    Class Name

    Export-only homologation (locally manufactured)

    Pathway

    ANPP export-only homologation

    Official Timeline
    Min

    90

    Max

    120

    Unit

    days

    Realistic Timeline
    Min

    4

    Max

    7

    Unit

    months

    Notes
    • Arrêté of 23 June 2021 Art. 9: the ANPP must decide within 90 days from admissibility, exceptionally extendable by the director general by up to 30 days
    • Art. 8 places an internal 60-day step inside that window, within which the dossier and technical evaluation reports must reach the homologation commission, itself extendable by 30 days when complementary information is requested
    • This route exists because Décret 20-324 Art. 16 carved export-only local manufacture out of the general homologation regime and left it to a ministerial arrêté
    • A rejected applicant may appeal to the ANPP within 30 days of notification
    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    Algeria arrêté du 23 juin 2021 (JO 62) — homologation des DM fabriqués localement et destinés exclusivement à l'exportation: décision 90 jours prorogeable de 30 jours (Art. 9)

    Url

    https://www.joradp.dz/FTP/JO-francais/2021/F2021062.pdf?znjo=62#page=24

    Effective Date

    2021-08-15

    Accessed Date

    2026-08-30

  • Id

    homologation-modification

    Class Name

    Modification of a homologation decision

    Pathway

    ANPP variation

    Official Timeline
    Min

    90

    Max

    120

    Unit

    days

    Realistic Timeline
    Min

    4

    Max

    7

    Unit

    months

    Notes
    • Arrêté of 23 June 2021 Art. 12: the ANPP must decide within 90 days from receipt of the modification request, exceptionally extendable by the director general by up to 30 days, with the clock suspended while complementary information is outstanding
    • Art. 9 applies the same 8-day admissibility examination used for original homologation, and an incomplete modification file is declared inadmissible
    • Art. 14 and 15: after a rejection the holder has 30 days to file a corrected request, which the ANPP must then decide within 30 days
    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    Algeria arrêté du 23 juin 2021 (JO 62) — modification de la décision d'homologation: décision 90 jours prorogeable de 30 jours (Art. 12), demande corrigée traitée en 30 jours (Art. 15)

    Url

    https://www.joradp.dz/FTP/JO-francais/2021/F2021062.pdf?znjo=62#page=22

    Effective Date

    2021-08-15

    Accessed Date

    2026-08-30

Key Requirements
  • Only an agréé pharmaceutical establishment may hold a homologation decision (Décret 20-324 Art. 32), and the agrément itself is a separately clocked step: the technical commission has 8 days to give its opinion, the minister 30 days to decide on each of the agrément préalable de réalisation and the agrément d'ouverture, experts 10 days to return technical evaluation reports, and the applicant 60 days to lift any reserves
  • Segments inside the 240-day homologation clock: 8 days for the admissibility examination (Art. 22), up to 30 days for the clinical-expert committee report (Art. 26), up to 30 days for the commission's opinion once seized and a further 30 if complementary information is sought (Art. 27), and 8 days for the commission to transmit that opinion to the director general (Art. 28)
  • At the end of the technical evaluation the applicant has a maximum of 15 days to certify that nothing changed during the review (Art. 29), and missing that window stalls the file
  • Local Authorized Representative required for foreign manufacturers
  • Homologation is valid 5 years from signature (Art. 34) and renewal must be filed at the latest 90 days before expiry (Art. 35)
  • A homologated device not actually placed on the market or exported within 18 months of notification may have its decision withdrawn (Art. 37)
Prior Approvals
  • Authority

    CE Mark (EU MDR)

    Accepted

    Yes

    Benefit

    Usable as technical and QMS evidence in the dossier. Algeria requires its own registration decision and publishes no recognition route or origin-based reduction.

    Timeline Savings

    None published

  • Authority

    FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    Usable as supporting technical evidence only, with no published reduction.

    Timeline Savings

    None published

Local Rep Required

Yes

Local Rep Name

Algerian Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

5 years from the date the homologation decision is signed (Décret 20-324 Art. 34), renewable on request filed at least 90 days before expiry

Last Updated

2026-08-30

Verification Status

official-verified

Official Sources
  • Title

    Algeria décret exécutif n° 20-324 du 22 novembre 2020 — homologation: recevabilité 8 jours (Art. 22), avis de la commission 30 jours (Art. 27), décision 240 jours prorogeable de 90 jours (Art. 30), validité 5 ans (Art. 34)

    Url

    https://www.miph.gov.dz/fr/wp-content/uploads/2021/06/05-Decret-executif-n%C2%B0-20-324-du-22-novembre-20-relatif-aux-modalites-dhomologation-des-dispositifs-medicaux.pdf

    Effective Date

    2020-11-22

    Accessed Date

    2026-08-30

  • Title

    Algeria arrêté du 23 juin 2021 (JO 62) — homologation des DM fabriqués localement et destinés exclusivement à l'exportation: décision 90 jours prorogeable de 30 jours (Art. 9)

    Url

    https://www.joradp.dz/FTP/JO-francais/2021/F2021062.pdf?znjo=62#page=24

    Effective Date

    2021-08-15

    Accessed Date

    2026-08-30

  • Title

    Algeria arrêté du 23 juin 2021 (JO 62) — modification de la décision d'homologation: décision 90 jours prorogeable de 30 jours (Art. 12), demande corrigée traitée en 30 jours (Art. 15)

    Url

    https://www.joradp.dz/FTP/JO-francais/2021/F2021062.pdf?znjo=62#page=22

    Effective Date

    2021-08-15

    Accessed Date

    2026-08-30

  • Title

    Algeria arrêté (JO 62 du 15 août 2021) pris en application du décret exécutif n° 21-82 — agrément des établissements pharmaceutiques de fabrication: avis de la commission technique 8 jours, décision ministérielle 30 jours, levée des réserves 60 jours

    Url

    https://www.joradp.dz/FTP/JO-francais/2021/F2021062.pdf?znjo=62

    Effective Date

    2021-08-15

    Accessed Date

    2026-08-30

Reviewed On

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 ANPP. Appoint a Algerian Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

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

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    ANPP 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. ANPP may issue questions.

    Duration

    240-330 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, ANPP issues Algeria 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 Algeria fees →
Jurisdiction Id

algeria

Country

Algeria

Country Code

DZ

Authority

ANPP

Low Risk Local
Min

150000

Max

150000

Currency

DZD

Per Product

Yes

High Risk Local
Min

300000

Max

300000

Currency

DZD

Per Product

Yes

Details
  • Id

    homologation-modification

    Item

    Homologation (marketing-authorisation) modification

    Currency

    DZD

    Amount Local

    150000

    Amount Local Formatted

    DZD 150,000

    Frequency

    Per modification

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.miph.gov.dz/fr/wp-content/uploads/2022/01/Decret-executif-n%C2%B0-21-551-fixant-les-modalites-de-recouvrement-et-daffectation-du-produit-de-la-redevance-des-produits-pharmaceutiques-et-des-dispositifs-medicaux..pdf

    Source Title

    Algeria Executive Decree 21-551: redevance schedule for pharmaceutical products and medical devices

    Source Effective Date

    2022-01-05

    Verified On

    2026-08-25

  • Id

    homologation-renewal

    Item

    Homologation renewal

    Currency

    DZD

    Amount Local

    300000

    Amount Local Formatted

    DZD 300,000

    Frequency

    Per renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.miph.gov.dz/fr/wp-content/uploads/2022/01/Decret-executif-n%C2%B0-21-551-fixant-les-modalites-de-recouvrement-et-daffectation-du-produit-de-la-redevance-des-produits-pharmaceutiques-et-des-dispositifs-medicaux..pdf

    Source Title

    Algeria Executive Decree 21-551: redevance schedule for pharmaceutical products and medical devices

    Source Effective Date

    2022-01-05

    Verified On

    2026-08-25

  • Id

    homologation-transfer

    Item

    Transfer of homologation to another holder

    Currency

    DZD

    Amount Local

    100000

    Amount Local Formatted

    DZD 100,000

    Frequency

    Per transfer

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.miph.gov.dz/fr/wp-content/uploads/2022/01/Decret-executif-n%C2%B0-21-551-fixant-les-modalites-de-recouvrement-et-daffectation-du-produit-de-la-redevance-des-produits-pharmaceutiques-et-des-dispositifs-medicaux..pdf

    Source Title

    Algeria Executive Decree 21-551: redevance schedule for pharmaceutical products and medical devices

    Source Effective Date

    2022-01-05

    Verified On

    2026-08-25

  • Id

    pharmaceutical-establishment-expertise

    Item

    Pharmaceutical-establishment file expertise

    Currency

    DZD

    Amount Local

    300000

    Amount Local Formatted

    DZD 300,000

    Frequency

    Per file

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.miph.gov.dz/fr/wp-content/uploads/2022/01/Decret-executif-n%C2%B0-21-551-fixant-les-modalites-de-recouvrement-et-daffectation-du-produit-de-la-redevance-des-produits-pharmaceutiques-et-des-dispositifs-medicaux..pdf

    Source Title

    Algeria Executive Decree 21-551: redevance schedule for pharmaceutical products and medical devices

    Source Effective Date

    2022-01-05

    Verified On

    2026-08-25

Notes
  • Amounts are those fixed in Art. 2 of Décret exécutif 21-551 of 30 December 2021 (JO n° 02 of 5 January 2022), in force since publication.
  • The published schedule lists no separate initial-homologation fee line; only modification, renewal, transfer, and establishment-expertise amounts are published.
  • Fee receipts are allocated 70% to the special allocation account n° 302-096 'Fonds pour les urgences et les activités de soins médicaux' and 30% to the ANPP (Art. 2).
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Algeria Executive Decree 21-551: redevance schedule for pharmaceutical products and medical devices

    Url

    https://www.miph.gov.dz/fr/wp-content/uploads/2022/01/Decret-executif-n%C2%B0-21-551-fixant-les-modalites-de-recouvrement-et-daffectation-du-produit-de-la-redevance-des-produits-pharmaceutiques-et-des-dispositifs-medicaux..pdf

    Effective Date

    2022-01-05

    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 Algeria certifications →
Slug

algeria

Market

Algeria

Confidence

low

Schemes
  • Id

    anpp-technical-evaluation-and-conformity-certificate

    Name

    ANPP technical evaluation and conformity certificate

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Décret exécutif 20-324 Art. 25 runs a four-phase evaluation (technico-regulatory evaluation; evaluation of physical, chemical and biological tests; evaluation of the risk-analysis report; evaluation of clinical data where applicable); the arrêté of 10 May 2021 Art. 4 requires the dossier to contain the results of pharmaceutical and technical tests (physico-chemical, physico-mechanical, biological or microbiological) and a certificate of conformity of the device to regulatory norms.

    Source Urls
    • https://www.miph.gov.dz/fr/wp-content/uploads/2021/06/05-Decret-executif-n%C2%B0-20-324-du-22-novembre-20-relatif-aux-modalites-dhomologation-des-dispositifs-medicaux.pdf
    Source Binding

    candidate

  • Id

    import-technical-conditions-cahier-des-charges

    Name

    Import technical-conditions cahier des charges

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    Imported Product

    Note

    Arrêté n° 25 of 12 October 2025 sets the cahier des charges of technical conditions for importing pharmaceutical products and medical devices for human medicine (cited in the ANPP serialization-strategy references); an earlier arrêté of 14 February 2021 fixed the cahier des conditions techniques à l'importation (JO 2021 n° 15 p. 17).

    Source Urls
    • https://www.miph.gov.dz/fr/wp-content/uploads/2026/04/la-strategie-de-la-serialisation.pdf
    Source Binding

    candidate

Official Sources
  • Authority

    Ministère de l'Industrie Pharmaceutique (ANPP)

    Topic

    décret exécutif 20-324 Art. 25 homologation evaluation phases

    Url

    https://www.miph.gov.dz/fr/wp-content/uploads/2021/06/05-Decret-executif-n%C2%B0-20-324-du-22-novembre-20-relatif-aux-modalites-dhomologation-des-dispositifs-medicaux.pdf

  • Authority

    Ministère de l'Industrie Pharmaceutique (ANPP)

    Topic

    serialization strategy references — import cahier des charges Arrêté 25 of 12 October 2025

    Url

    https://www.miph.gov.dz/fr/wp-content/uploads/2026/04/la-strategie-de-la-serialisation.pdf

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Need to apply Algeria's requirements to a product?
Confirm the current ANPP pathway, evidence, and local-role details for the actual device before filing.
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