Algeria
Algeria is the largest African country and the third-largest Arab economy. It has one of Africa's largest economies, due mostly to its large oil and gas reserves (it is a major supplier of natural gas to Europe).
Algeria has a population of around 46 million inhabitants, with 20 million people under the age of 24. Up to 99% of the Algerian population is either from Arab or Amazigh ethnicity, while Europeans make up less than 1% of the entire population. The Islamic Sunni Faith is the dominant religion.
The right of all citizens to health care is embodied in the country’s constitution. In 1974 the system of free health care in public facilities came into effect. This has resulted in a predominantly public service delivery system with limited but increasing private participation, especially during the last two decades.
The Ministry of Health, Population and Hospital Reforms is responsible for the overall management of the public health system and regulates the provision of private health services as well as the NGOs. However, several other ministries are technically involved in managing the healthcare sector, usually complicating the decision-making process and overall health policy. For instance, the Ministry of Industry & Pharmaceutical production is responsible for managing continuous supply to the local market of drugs and medical devices and their regulation, the Ministry of Labour & Social security is responsible for the national health insurance schemes, while the Ministry of Education & Scientific research governs all physicians and other healthcare professionals training.
The Algerian healthcare system consists of over 242,000 healthcare professionals in the public sector, 23,563 private offices, 9,751 specialized centres and 7,298 general practices, as well as 6,514 dental practices.
Public Sector structure
The Algeria public healthcare system is divided into 185 health districts that are each tasked with addressing the healthcare needs of the residents within their jurisdictions. Each district aims to include at least one general hospital and several polyclinics, health centres and treatment rooms, which administer primary and secondary care.
Private healthcare
The private health sector in Algeria is filling in the gaps not addressed by the public system. Private medical facilities are becoming prominent in Algeria. Today, there are over 250 private clinics operating, with plans to establish more. However, access to private medical care remains extremely limited as many of their services are typically not covered by the public health insurance plan. Although an increasing number of insurance agreements are implemented by different medical insurance institutions and private treatment centres, many more remain. Overall, few Algerians can afford full out-of-pocket payments for medical treatment in private facilities.
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Healthcare Business in Algeria
The Algerian healthcare sector continues to grow. With a good deal of patience and commitment, there are considerable opportunities for foreign companies in Algeria. Algeria’s healthcare sector relies heavily on imported goods. Press reporting suggests that cardiovascular diseases, cancer, hypertension, diabetes, respiratory illnesses and allergies are on the rise. The population is increasingly aware of cutting-edge medical procedures such as laser corrective eye surgeries, panoramic dental radiology, and plastic surgery. Algerian demand for quality medical equipment and disposables is considerable.
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Innovative Technologies offering distinctive advantages for patients and/or HCPs are highly regarded by local KOLs and usually find an easy entry in the local market. Therefore, SaMDs as well as AI-based SaMDs should relatively easy gain a considerable market share in the coming decade.
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Despite the government’s challenging fiscal situation, the share of the total national operating budget allocated to health increases every year with the objective to improve access to quality health services for all Algerians.
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All international companies must create a legal entity with a local partner in accordance with the 51/49 investment law.
Algerian government encourages local and foreign investors to invest in Algeria by offering various advantageous measures in terms of investments which include provisions related to financing, tax advantages, land advantages, etc. Tools that give food for thought, especially knowing that local production under certain conditions could result in a decision to ban the importation of products that are similar to the ones produced locally.
Medical Device and IVD registration
In Algeria, regulation of medical devices falls under the jurisdiction of the Algerian Ministry of Industry and Pharmaceutical Production and is operated under the National Agency for Pharmaceutical Products (L’Agence National des Produits Pharmaceutique - ANPP). This regulatory body oversees the registration and monitoring of medical devices to ensure their safety, efficacy and that the quality standards which are required by the Algerian Regulations are met before they enter the market. The agency also monitors the compliance of such medical devices with regulatory requirements once put into the market through means of direct reporting and regular post-approval inspections on the ground.
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PCH: Pharmacy Centrale des Hôpitaux (Central Pharmacy of Hospitals) is an independent body that falls under jurisdiction of the Ministry of Industry and Pharmaceutical Production that holds the responsibility to supply the government hospitals with all their medical devices and IVD requirements. Such a mission is made possible mainly through international tenders where national consumptions are gathered and put out for international medical devices manufacturers to compete on.
In accordance with the provisions of the legislation and regulations in force, the placing on the market of any ready-to-use medical device or IVD, locally manufactured or imported is subject to Registration at the Local Authorities of Regulation (NAPP) (Ref: Articles 212 and 213 of Law N°. 18-11 of 18th of Chaoual 1439 corresponding to the 2nd of July 2018, amended and supplemented, relating to health).
Medical device Classification
Medical devices are mainly classified in order of criticality, based on the potential risk to the patient, and fall into four main Classes as follows:
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Class I: MDs with Low potential risk
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Class IIa: MDs with moderate potential risk
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Class IIb: MDs with High potential risk
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Class III: MDs with Critical potential risk.
However, the final medical device classification must the evolution of international standards while the EU classification system of the Medical Devices Directive (MDD) 93/42/EEC is primary regarded and followed.
Special requirements
Special requirements for labelling are to be respected, while both Arabic and French languages are required.
Medical devices registration in Algeria involves thoroughly scrutinizing documentation, including technical specifications and clinical data, to assess compliance with established regulations.
All documents must be original documents and must be submitted in the French language (in case the original documents are issued in another language, an official translation in French has to be added to the registration dossier). The Legal manufacturer remains the only responsible for the conformity of the translated document with its original version.
Medical device regulations are continually evolving in Algeria and new changes and requirements are often published through individual notes. Such notes are usually applied for a short period of time before they become formal changes or disappear forever. Several issues are temporarily treated by case, which makes it difficult for foreign manufacturers to follow-up on the processing of their medical device registration without a well-skilled local AR.
By adhering to the regulations set forth by the Ministry of Industry and Pharmaceutical Production and keeping the right level of communication with the ANPP (?) agents, manufacturers can navigate the registration process smoothly and contribute to providing safe and effective medical devices to the Algerian market.
Certificate Holder and Local AR
Although the Legal Manufacture is the certificate holder, a local representative is required to process the registration of medical devices in Algeria. Whoever handles the Regulatory Affairs on behalf of the Legal Manufacturer is locally called the Registration Certificate’s Operator (RCO).
Registration of Medical devices in Algeria is made either through:
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The Legal Manufacturer in the case the manufacturer is legally established in the country
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The Local Authorized Representative whose role is mainly to operate as the Registration Certificate’s Operator.
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The local Distributor (when given the authorization by the legal manufacturer at its own risks). In this case, changing the distributor later could make the entire business under threat as the distributor is also the RCO. And changing the registration certificate might be impossible if the distributor isn’t fully cooperative.
The Registration Certificate will be issued with the names of all three business partners included, namely, the Legal Manufacturer, the RCO, and the Distributor.
Officially, product registrations are valid for 5 years from the date of issuance. All changes shall be notified. Changes that affect the assessment of the safety and/or performance of the medical devices require new registration.
Time-to-market
The officially timelines set forth within the official decrees are not enforced yet (??). However, upon submission of the registration dossier to the local Authorities of Regulation, namely ANPP, the local distributor can submit the request for Import license which would give him the right to start importing the goods to the market.
Import licence
An Import license is a must have document that allows the local distributor to import any medical device to the Algerian market. It’s usually delivered within 30 days.
Post Market Surveillance (PMS)/Vigilance:
The Algerian Authority of regulation, namely ANPP also conducts post-market surveillance to monitor the performance and safety of medical devices already in circulation. Healthcare professionals are required to report any disfunction and/or defect and/or non-compliance with the safety/performance requirements of a medical device they encounter in their everyday practice.
Direct reporting is a strong mean of post-market surveillance. The ANPP collects and evaluates post-market information on medical devices, with a particular focus on adverse events/incidents and post-market vigilance. The guidelines are similar to those in the EU. If a device is involved in an incident, the manufacturer is requested through its local AR to immediately notify the ANPP and then submit an incident report and furthermore comply with all decisions and directives given.
We prioritize keeping our clients informed about the evolving regulations and requirements particularly for medical devices and the opportunities to expand the business in the country. By navigating the complexities of regulatory frameworks and simplifying the registration process, we enable businesses to capitalize on opportunities for growth and success.
