Algeria medical device registration resources

Competent authority

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…

Advisory homologation commission at ANPP

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, t…

Legal framework for device homologation

Décret exécutif n° 20 324 of 22 November 2020 (JO n° 69), adopted under Art. 230 of loi n° 18 11 of 2 July 2018 on health, governs device homologation; it is completed by ministerial arrêté…

Transition: regularization of non-homologated devices

Devices marketed without a homologation decision may continue to be supplied but their dossiers must be regularized within two years from 22 November 2022 (i.e. by 22 November 2024), per Ar…

Device definition and scope

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…

IVDs, custom-made and active implantable devices in scope

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…

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

Class I, Class IIa, Class IIb, Class III

Market-access route (homologation)

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,…

Eligible applicants

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 wit…

Origin-country registration evidence in dossier

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…

Renewal requires maintained origin registration

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 marketin…

Homologation holder/operator responsibility

The holder (détenteur) and/or operator (exploitant) of the homologation decision is responsible for placing the device on the market; only duly agréé pharmaceutical establishments can hold…

Application filed by pharmacist technical director

The homologation or renewal dossier must be deposited with ANPP by the pharmacien directeur technique of the pharmaceutical manufacturing and/or exploitation establishment.

Import establishment agrément valid 2 years

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, renew…

Premises minimum area for device import

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…

Dossier format: five parts

The dossier content (administrative data; technical summaries; chemical/physical/mechanical/biological information incl. sterilization validation and risk evaluation; performance and non cl…

Samples for quality control

On ANPP request the applicant establishment must submit the device and, where applicable, its raw materials, intermediates or other components, reagents and specific means needed for qualit…

DM appointment portal rdvdm.anpp.dz

Appointments for device (DM) filings are taken on the platform rdvdm.anpp.dz; the booking form opens every Tuesday from 10:00 to Thursday 10:00, and dossiers are received on Sunday, Monday…

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

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…

Packaging in Arabic and used foreign language

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…

Essential mentions on label and IFU

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 h…

GMP/ISO/GLP/GCP authorization evidence in dossier

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 de…

ANPP technical evaluation and conformity certificate

Electrical safety

Import technical-conditions cahier des charges

Import CoC / PVoC

Homologation (marketing-authorisation) modification

DZD 150,000

Homologation renewal

DZD 300,000

Medical-device homologation · ANPP registration

240-330 days

Export-only homologation (locally manufactured) · ANPP export-only homologation

90-120 days

Modification of a homologation decision · ANPP variation

90-120 days

Homologation valid 5 years

The device homologation decision is valid for five years from its date of signature (identical for export only decisions).

Renewal application at latest 90 days before expiry

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 ex…

Immediate declaration of changes and foreign restrictions

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);…

Modifications require prior submission; minor/major/moderate categories

Any modification of a homologation decision must be submitted to ANPP before implementation; modifications are categorised (administrative / technical / performance safety efficacy materiov…

Serialization strategy: separate rules for devices

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…

Clinical data or demonstrated equivalence

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 documentati…

No source-verified answer is published for this dimension yet.

Renewal dossier: materiovigilance and benefit/risk updates

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…

ANPP duty to act on device danger signals

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…

Recall duties of the holder on withdrawal

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…

Temporary withdrawal up to 12 months

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 a…

No source-verified answer is published for this dimension yet.

Refusals must be reasoned

A homologation application is refused after commission opinion on defined grounds (altered characteristics/performance, non conformity with the dossier, unfavourable safety report, inadequa…

30-day recourse against export-route rejection

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 modif…