Regulatory Requirements for Medical Device Registration in Algeria

As the largest nation in Africa, Algeria is home to around 40 million people. Its strong public healthcare system provides free and readily available medical services to all residents. This has positioned Algeria as a notable contributor to pharmaceutical exports, especially in the Middle East and Africa. Nonetheless, the country's capacity for manufacturing high-end pharmaceuticals is somewhat restricted, resulting in a significant dependency on imported medical devices. In this blog post, we aim to furnish a detailed manual on registering medical devices in Algeria, outlining crucial elements and prerequisites.

The regulatory requirements for medical device registration in Algeria are governed by the Ministry of Health, Population, and Hospital Reform (MHPHR). The primary law regulating medical devices in Algeria is Ordinance No. 05-03 of January 5, 2005, which outlines the general framework for the regulation of medical devices. This ordinance is supported by several decrees and circulars that provide more detailed guidelines for the registration and approval of medical devices.

The process of medical device registration in Algeria is governed by stringent regulations enforced by different regulatory bodies. This guide provides an in-depth breakdown of these regulations, requirements, classification of medical devices, and necessary documentation to help manufacturers ensure compliance and facilitate market entry.

Who Regulates Medical Devices in Algeria?

Medical devices in Algeria fall under the jurisdiction of the Directorate of Pharmacy (Direction de la Pharmacie et du Médicament or DPM), a division within the Ministry of Health and Population (MOHP). Working in tandem with the National Laboratory for the Control of Pharmaceutical Products (LNCPP), the DPM oversees the registration and regulatory procedures.

Regulatory Authority

The primary regulatory bodies in Algeria responsible for medical device regulations are:

1. Directorate of Pharmacy: Direction de la Pharmacy et du Medicament (DPM)
2. National Laboratory of Control of Pharmaceutical Products (LNCPP)

Medical Device Regulation

Medical devices in Algeria are regulated under the Article 7 – Executive Decree No. 11-380, dated November 21, 2011. This decree sets forth the requirements for the registration, marketing, and monitoring of medical devices within the country.

Official Language

Documentation and submissions must be prepared in the official languages:

1. Arabic
2. French

Classification of Medical Devices

Medical devices in Algeria are classified according to a four-tier system which is aligned with international standards:

1. Class I
2. Class IIa
3. Class IIb
4. Class III

How to Register Medical Devices in Algeria?

To obtain approval for selling medical devices in Algeria, the MOHP must grant its consent. All pertinent documents need translation into either French or Arabic, Algeria's official languages. These documents must be submitted to both the Directorate of Pharmacy and the National Laboratory for the Control of Pharmaceutical Products.

Registration Procedure

Following is the standardized process for medical device registration in Algeria:

1. Appoint a Local Authorized Representative: Foreign manufacturers must appoint a local representative in Algeria who will handle all correspondences with the DPM.
2. Prepare Registration Application: The application must include all necessary documentation detailing the device's compliance with Algerian regulations.
3. DPM Approval: The DPM reviews the application and, upon approval, grants registration which allows the device to be marketed in Algeria.

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What Documents are Required for Medical Device Registration in Algeria?

To register a medical device in Algeria, the following documents are typically required:

1. Information on the Manufacturer:

• Application form
• Manufacturer and distributor details
• Declaration of conformity
• CE certificate or equivalent

2. Information on the product documents required as follows:

• Instruction for use
• Label
• Product description
• Details on the biological product
• Risk class
• Storage conditions
• Device life cycle
• Device composition
• Device images
• Mechanism of action
• Indications, contraindications, warnings
• Method of sterilization
• The material used in the packaging
• Description of the inspections made on raw materials
• Report on the manufacturing process
• Report on the test mode on the device
• Clinical data

Required Documentation

Here is a detailed list of the documents required for registration:

Document Type	Description
Application Form	A complete application form provided by DPM.
Manufacturer and Distributor Information	Details about the manufacturer and the local distributor.
Declaration of Conformity	A statement that the device complies with all applicable regulations.
CE Certificate or equivalent	Proof that the device meets European safety, health, and environmental protection standards.
Product Information Documents	Includes instructions for use, product description, risk classification, storage conditions, device life cycle, composition, images, mechanism of action, clinical data, and reports on test mode, manufacturing process, and inspection on raw materials.

Post-market Surveillance

Post-market requirements are critical to ensure the ongoing safety and efficacy of the medical device:

Adverse Event Reporting: Any adverse events or irregularities must be reported back to the DPM.

What are the Post-Approval Requirements for Medical Devices in Algeria?

After receiving approval and entering the market, manufacturers or authorized agents must adhere to post-approval requirements, which may include:

• Preparation of incident, 
• Adverse event, and 
• Recall reports associated with the use of the medical device.

Submission of these reports to the Directorate of Pharmacy for evaluation and potential removal of the device from the market if necessary.

Legalized/Notarized Documents

Certain documents might require legalization or notarization through the Chamber of Commerce and the Algerian embassy.

Applicable Quality Management System (QMS)

The Quality Management System applicable for medical devices in Algeria is: ISO 13485:2016

Registration Timeline and License Validity

1. Registration Timeline: The registration timeline is not explicitly defined by the DPM.
2. License Validity: The registration license is valid for three years.

Conclusion

Compliance with the specified regulatory requirements is essential for the successful registration and marketing of medical devices in Algeria. Manufacturers should ensure all documents are correctly prepared and translated, where necessary, into Arabic or French. Regular updates and continuous monitoring of regulatory guidelines are recommended to stay compliant with Algerian medical device regulations.

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