Understanding the Algerian Regulatory Framework
Algeria enforces strict regulatory standards for medical devices to protect public health and align with international best practices. Any medical device intended for commercialization must comply with national regulations and undergo evaluation by the competent authority.
Our expertise allows partners to navigate this complex process with confidence and efficiency.
Step 1: Medical Device Classification
- Class I – Low Risk: Devices with minimal potential risk to patients.
- Class IIa / IIb – Moderate to High Risk: Devices requiring extended safety and performance evidence.
- Class III – Critical Risk: Life-supporting or life-sustaining devices requiring the highest regulatory control.
Accurate classification is essential, as it impacts documentation requirements,review timelines, and approval procedures.
Step 2: Technical Documentation Preparation
A complete and well-structured technical dossier is mandatory for regulatory approval. This documentation demonstrates compliance with safety, performance, and quality standards.
- CE Certificate or equivalent international certification
- Declaration of Conformity
- User manual and product labeling
- Biocompatibility, safety, and performance reports
Advanced Med Pharma supports partners in preparing, validating, and aligning all documentation with Algerian regulatory expectations.
Step 3: Registration via E-TASDJIL
Once the technical documentation is complete, registration is initiated through the E-TASDJIL platform.
- Payment of regulatory fees
- Issuance of the Bordereau de Versement (BV)
Proper execution of this step prevents administrative delays or rejection.
Step 4: Submission to the National Authority (ANPP)
The full registration file is submitted to the National Agency for Pharmaceutical Products (ANPP) for regulatory review.
The authority conducts a detailed evaluation of safety, quality, and regulatory compliance. Additional information or clarification may be requested if needed.
Step 5: Market Authorization
Following successful review, market authorization is granted, allowing the medical device to be legally distributed and used by healthcare professionals in Algeria.
This final approval confirms full compliance with national medical device regulations.
Why Choose Advanced Med Pharma?
At Advanced Med Pharma, we are committed to delivering compliant, safe, and high-quality medical devices that meet Algerian regulations and international standards.
We support healthcare professionals and industry partners by ensuring regulatory compliance, faster market access, and reliable medical solutions.
Every step matters — and we are with you at each one.
