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ANPP · structured requirements

🇩🇿 Algeria medical device regulatory data

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

46 facts23 dimensions13 official sourceslatest verification 2026-09-16

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.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Renewal application at latest 90 days before expiry

renewal.request-90-days-before-expiry
Fact-level verified

The homologation decision is renewable on request of the holder and/or operator, after commission opinion; the application with its dossier must be filed at the latest 90 days before the expiry date of the decision (renewal dossier in consolidated two-part form per annexe III; ANPP may require the full five-part dossier and may initiate quality control or performance expertise).

Effective from 2020-11-22

Withdrawal if not marketed within 18 months

validity.18-months-marketing-requirement
Fact-level verified

If the homologated device is not effectively placed on the market or exported within 18 months following notification of the homologation decision, ANPP reserves the right to withdraw the decision.

Effective from 2020-11-22

JO text contains the typographical error 'dix-hui (18) mois'.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority

authority.competent-authority
Fact-level verified

The Agence Nationale des Produits Pharmaceutiques (ANPP), a public institution under the tutelle of the Ministère de l'Industrie Pharmaceutique, issues the homologation decision required to place medical devices on the Algerian market, after opinion of the device homologation commission.

Conditions
  • Applies to all device classes and to industrially manufactured, imported and exported devices.

Effective from 2020-11-22

Advisory homologation commission at ANPP

authority.homologation-commission
Fact-level verified

A commission d'homologation des dispositifs médicaux created at ANPP gives its opinion on applications submitted by the ANPP Director General, including renewal, modification, withdrawal, transfer and cession of homologation decisions and any question of quality, safety, innocuity and performance; it includes representatives of the pharmaceutical-industry and health ministries and the national pharmacovigilance and materiovigilance centre.

Conditions
  • Commission meets in ordinary session once every 3 months (Art. 7).

Effective from 2020-11-22

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Immediate declaration of changes and foreign restrictions

changes.immediate-declaration-duty
Fact-level verified

During the validity of the homologation decision, the holder and/or operator must declare immediately to ANPP: any modification of the elements of the initial declaration (Art. 19 dossier); and any prohibition or restriction imposed by the competent health authority of the country of origin or of any other country where the device is marketed, plus any new information that could influence the safety assessment of the device.

Effective from 2020-11-22

Modifications require prior submission; minor/major/moderate categories

changes.prior-submission-categories
Fact-level verified

Any modification of a homologation decision must be submitted to ANPP before implementation; modifications are categorised (administrative / technical / performance-safety-efficacy-materiovigilance, each requiring a distinct application) and graded minor, major or moderate by risk impact; minor modifications not affecting the decision's details and not requiring continued surveillance may be submitted within 12 months following implementation. Modification filing requires payment of a redevance.

Conditions
  • Characteristics, presentation conditions and documentation per category are set by the ANPP Director General (Art. 4 al. 3).

Effective from 2021-08-15

Classification rules

What local class follows from which rules and decisive product facts?

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Classification detail 2

classification.detail-2
Fact-level verified

Applicant self-classification: the homologation dossier must state the classification of the device and the classification rules applied (arrêté 10 May 2021, Art. 4, same requirement in renewal and regularization dossiers); admissibility of export-route files includes verification of the positioning and classification of the device.

Classification scheme (full axis)

classification.scheme-classes
Fact-level verified
Axis

Classes I, IIa, IIb and III by order of criticality (décret exécutif 20-324).

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

MIPh (Ministère de l'Industrie Pharmaceutique)

Notes
  • Art. 17 décret 20-324: Classe I faible / IIa modéré / IIb élevé / III critique; classification takes account of the evolution of international consensus; no local GHTF/MDR rule annex is referenced beyond the class labels.
  • The homologation dossier must state the device classification and the classification rules applied (arrêté 10 May 2021, Art. 4; same requirement in renewal and regularization dossiers).

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical data or demonstrated equivalence

clinical.data-or-demonstrated-equivalence
Fact-level verified

For devices requiring clinical studies, clinical data must appear in the homologation dossier, unless use of existing clinical data can be justified through available scientific documentation where the applicant demonstrates proven equivalence of the device with the device to which those data relate.

Effective from 2020-11-22

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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IVDs, custom-made and active implantable devices in scope

scope.ivd-custom-made-active-implantable
Fact-level verified

The single dossier format applies to all device types, explicitly including IVDs (dispositifs médicaux de diagnostic in vitro) and active implantable devices; the dossier must designate the device as, where relevant, a device containing a medicinal product, blood component, animal-origin material, latex or phthalates, an active implantable, an IVD, or a custom-made (sur mesure) device.

Effective from 2021-07-14

Device definition and scope

scope.statutory-device-definition
Fact-level verified

Décret 20-324 applies to dispositifs médicaux à usage de la médecine humaine as defined in Articles 212 and 213 of loi n° 18-11, covering every ready-to-use industrially manufactured device, whether imported or exported.

Conditions
  • Locally manufactured devices destined exclusively for export follow a separate arrêté procedure (Art. 16 al. 2).

Effective from 2020-11-22

The text of arts. 212-213 of loi 18-11 itself was not opened; scope is taken from the decree's own reference.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Payment proof attached to dossier

dossier.fee-quittance
Fact-level verified

Filing a homologation or renewal dossier is subject to payment of the droit/redevance by the applicant establishment; a quittance evidencing payment must be attached to the dossier (ANPP Note N°47-2025 of 4 December 2025 specifies the payment proof documents for registrations and device homologations).

Effective from 2021-07-14

Dossier format: five parts

dossier.format-five-parts
Fact-level verified

The dossier content (administrative data; technical summaries; chemical/physical/mechanical/biological information incl. sterilization validation and risk evaluation; performance and non-clinical reports; clinical reports) is presented in five parts per the annexes to the 10 May 2021 arrêté, with a strictly defined numbering system; the same format applies to homologation, renewal and modification applications.

Effective from 2021-07-14

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Import establishment agrément valid 2 years

establishment.import-agrement-validity
Fact-level verified

Import establishments for pharmaceutical products and medical devices require a ministerial agrément (under décret n° 21-82 of 23 February 2021); the agrément is issued for two years, renewable; applications are filed by the pharmacist technical director via secure electronic channel.

Conditions
  • Arrêté of October 2025 sets dossier elements, processing and substantial modifications; arrêté number illegible in the official scan.

Scanned official text (OCR): 'L'agrement est delivre pour une duree de deux (02) annees renouvelables.'

Annual import report by 31 January

establishment.import-annual-report
Fact-level verified

The agréé import establishment must keep purchase and sales documentation and submit an annual statement of import operations to the competent ministry services at the latest by 31 January of the following year, on a pre-established template.

Scanned official text (OCR).

Premises minimum area for device import

establishment.import-premises-device
Fact-level verified

Where the import activity concerns medical devices, the establishment's premises must be fit for that activity and at least 90 m²; where it concerns both pharmaceutical products and devices simultaneously, premises must be at least 390 m² (pharmaceuticals alone: 300 m²).

Scanned official text (OCR).

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Packaging in Arabic and used foreign language

label.arabic-and-foreign-language
Fact-level verified

The dossier must include a mock-up of the primary and secondary packaging in clear, easily legible characters in Arabic and in any foreign language in use in Algeria, per annexe I of the 10 May 2021 arrêté; ANPP Note N°42-2026 of 11 May 2026 addresses conformity of mandatory packaging mentions for pharmaceutical products and devices.

Effective from 2021-07-14

Essential mentions on label and IFU

label.essential-mentions
Fact-level verified

The homologation decision carries the obligation to indicate on the labelling (étiquetage) and the instructions for use (notice d'instruction) all mentions essential for the protection of health; the decision itself states commercial name, designation, classification, characteristics, holder and operator names/addresses, manufacturers and manufacturing sites, storage conditions and duration, and certifying bodies.

Effective from 2020-11-22

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Renewal dossier: materiovigilance and benefit/risk updates

pms.renewal-materiovigilance-summary
Fact-level verified

The renewal dossier must include a summary of the materiovigilance system, the benefit/risk evaluation of the device in Algeria and in the country of origin, and the chronological detail of post-homologation modifications submitted to ANPP (approved or under approval).

Effective from 2021-07-14

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Digital-format DM dossiers (Note N°28-2026)

portal.digital-dossier-note28
Fact-level verified

ANPP Note N°28-2026 of 15 March 2026 sets the modalities for depositing device homologation dossiers in digital format; Note N°06-2026 of 14 January 2026 makes reception forms available for pharmaceutical products and devices.

Effective from 2026-03-15

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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GMP/ISO/GLP/GCP authorization evidence in dossier

qms.gmp-iso-glp-gcp-evidence
Fact-level verified

The dossier must include a document showing that all actors involved in manufacture and, where applicable, clinical trials of the finished product are authorized in their country for the declared activities, notably as regards compliance with good manufacturing practices (BPF), ISO standards, good laboratory practices (BPL) and good clinical practices (BPC); the renewal dossier must show these authorizations remain in force.

Effective from 2021-07-14

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Recall duties of the holder on withdrawal

recall.holder-lot-duties
Fact-level verified

When a homologation decision is withdrawn (temporarily or definitively), the holder and/or operator must take all useful measures to stop distribution of the device, must withdraw, destroy or re-ship the marketed lot(s), and must comply with all measures taken by ANPP; withdrawal, destruction or re-shipping of non-conforming devices are at the holder's/operator's cost, with modalities set by ministerial arrêté.

Effective from 2020-11-22

Temporary withdrawal up to 12 months

recall.temporary-withdrawal-12-months
Fact-level verified

For reasons of health security and/or quality, ANPP can pronounce temporary withdrawal of the homologation decision for a period not exceeding 12 months; the withdrawal becomes definitive at the end of that period if the holder has not lifted the reservations that motivated it; withdrawal requests can originate from the ministers, ANSS, national health institutions, national and international pharmaceutical regulation bodies, and materiovigilance establishments; withdrawal decisions must be motivated and may be publicised.

Effective from 2020-11-22

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Eligible applicants

registration.applicant-establishments
Fact-level verified

Only agréé pharmaceutical manufacturing and/or exploitation (distribution) establishments, as defined in Articles 218 and 219 of loi n° 18-11, may file a device homologation application with ANPP; the homologation decision can likewise only be granted to such establishments.

Effective from 2020-11-22

Export-only homologation route

registration.export-only-route
Fact-level verified

Locally manufactured devices destined exclusively for export must also be homologated, after opinion of the homologation commission, under a dedicated arrêté procedure (arrêté of 23 June 2021): application must state the exclusive-export destination, follows the standard dossier, with a 90-day decision (extendable 30 days) and a decision valid 5 years.

Conditions
  • Export-only route; placing on the Algerian market remains subject to the standard route.

Effective from 2021-08-15

Market-access route (homologation)

registration.homologation-route
Fact-level verified

Route to market is the national homologation procedure before ANPP: dossier deposited by an agréé pharmaceutical establishment (appointment via rdvdm.anpp.dz; reception days Sunday, Monday, Wednesday), admissibility check, technical evaluation, commission opinion, decision of the ANPP Director General. Since 15 March 2026, homologation dossiers are deposited in digital format per ANPP Note N°28-2026, and Note N°39-2026 governs lifting of reservations on DM dossiers.

Conditions
  • Applies to all device classes; no separate IVD route - IVDs use the same dossier format.

Baseline market-access fact upgraded: appointment platform and 2026 digital-dossier note verified on ANPP official pages.

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 (6 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.

AlgeriaSource authority not specified

Regulatory reference

Renewal requires maintained origin registration

reliance.renewal-maintained-origin-registration
Fact-level verified

The renewal dossier must include a CLV or equivalent proving that registration and commercialization of the device are maintained in the country of origin, a renewed origin-country marketing authorization (and CPP where applicable), and a benefit/risk evaluation of the device in Algeria and in the country of origin.

Effective from 2021-07-14

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

AlgeriaSource authority not specified

Regulatory reference

Origin-country registration evidence in dossier

reliance.origin-country-evidence
Fact-level verified

The homologation dossier must include a certificate of free sale (CLV) or equivalent document from the pharmaceutical regulatory authority (or other recognized authority) showing the device is registered and marketed in the country of origin, plus the origin-country marketing authorization and CPP where applicable, and copies of marketing authorizations obtained in other countries.

Conditions
  • CPP 'le cas échéant'; applies to all classes.

Effective from 2021-07-14

AlgeriaSource authority not specified

Regulatory reference

Reliance on strict authorities for modifications

reliance.strict-authority-modifications
Fact-level verified

ANPP may take into account evaluations performed by a 'strict' pharmaceutical regulatory authority or by an authority recognized by ANPP when approving device modification applications.

Conditions
  • Modification route only; no equivalent provision opened for initial homologation.

Effective from 2021-08-15

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Clock suspension and lapse of application

clocks.stop-clock-and-lapse
Fact-level verified

In all cases the review clock is suspended when additional information is requested; if the applicant establishment fails to provide the requested supplements within the time allotted, the homologation application lapses (devient caduque).

Conditions
  • Stated identically for the standard route (Art. 30), the export-only route (arrêté 23/06/2021, Art. 9) and modifications (Art. 12).

Effective from 2020-11-22

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.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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30-day recourse against export-route rejection

appeal.export-recours-30-days
Fact-level verified

Against a rejection of an export-only homologation application, the establishment may file a recourse (recours) with ANPP within 30 days of notification of the rejection decision; for modifications, a corrected application addressing the rejection motives may be filed within 30 days of receipt, decided within 30 days.

Conditions
  • Export-only route: Art. 11 of the 23 June 2021 arrêté; modification route: Arts. 14-15 of the same arrêté.

Effective from 2021-08-15

Refusals must be reasoned

appeal.motivated-refusal
Fact-level verified

A homologation application is refused after commission opinion on defined grounds (altered characteristics/performance, non-conformity with the dossier, unfavourable safety report, inadequate manufacturing/control processes, insufficient documentation); any refusal notified by the ANPP Director General must be motivated.

Effective from 2020-11-22

Lifting of reservations on DM dossiers (Note N°39-2026)

appeal.reservation-lifting-note39
Fact-level verified

ANPP Note N°39-2026 of 22 April 2026 governs the lifting of reservations raised on device homologation dossiers; Note N°47-2025 of 4 December 2025 governs the payment-proof documents due for registration and device homologation requests.

Effective from 2026-04-22

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Serialization strategy: separate rules for devices

traceability.serialization-devices-separate
Fact-level verified

The Ministry of Pharmaceutical Industry's serialization strategy (version 1.0, published April 2026, based on Art. 319 of loi 18-11) states that medical devices will be subject to separate (différentes) serialization regulations from medicines; adopted technical standards include ISO/IEC 16022:2024, ISO/IEC 15418:2016, ISO/IEC 15459-3/4, ISO/IEC 15434:2019 and ISO/IEC 15415:2024.

Conditions
  • Strategy document, not yet a binding device UDI obligation; no implementation dates for devices are set in the document.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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ANPP duty to act on device danger signals

vigilance.anpp-danger-powers
Fact-level verified

ANPP must act when a pharmaceutical product or medical device presents, or is suspected of presenting, a danger; its missions include quality control and expertise of devices, inspection of sites against device norms, and suspension of homologation decisions.

Related structured datasets

Classification systems · 1 record
Open Classes I, IIa, IIb and III by order of criticality (décret exécutif 20-324). →
Id

algeria:medical-device

Jurisdiction Id

algeria

Domains
  • medical-device
Name

Classes I, IIa, IIb and III by order of criticality (décret exécutif 20-324).

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

MIPh (Ministère de l'Industrie Pharmaceutique)

Official Domains
  • miph.gov.dz
  • joradp.dz
Notes
  • Art. 17 décret 20-324: Classe I faible / IIa modéré / IIb élevé / III critique; classification takes account of the evolution of international consensus; no local GHTF/MDR rule annex is referenced beyond the class labels.
  • The homologation dossier must state the device classification and the classification rules applied (arrêté 10 May 2021, Art. 4; same requirement in renewal and regularization dossiers).
Source Status

official-source-verified

Source Title

Décret exécutif n° 20-324 du 22 novembre 2020, Art. 17

Source 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

Verified On

2026-08-25

Source Supports
  • class-axis
Registration pathways, prior approvals and planning · 1 record
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
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
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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