ALGERIA
Algeria – A Strategic Gateway to the North African Healthcare Market
Algeria provides a powerful entry point for healthcare and medical technology companies aiming to expand across North Africa. With a rapidly evolving regulatory environment, a strong demand for digital health solutions, and one of the region’s largest healthcare markets, Algeria is positioning itself as a central hub for medical innovation and regional growth.
At Simon MedTech Solutions, we support international manufacturers, software developers, and distributors through every regulatory and operational step required to enter and thrive in the Algerian market. From Medical Device homologation, local representation, quality compliance, digital health pathways, and post-market activities, we deliver end-to-end support tailored to your expansion strategy.
+46.8
Million in habitants
~ US $900 million
value of medical-device imports in 2023, placing Algeria among the top 5 African
+586
public health establishments
Our Services
Our services are designed to guide international manufacturers through every regulatory and operational requirement needed to bring medical devices to the Algerian market. From market entry to long-term compliance, we provide comprehensive, reliable, and locally aligned solutions to ensure a smooth and successful expansion.
Homologation
We manage the complete lifecycle of your medical device approvals in Algeria—from initial homologation to renewal of certificates and variations. Our team ensures full compliance with local regulations and smooth interactions with ANPP & MIP.
Local Representation
(Authorized Representative) We act as your official representative in Algeria, meeting all legal obligations for foreign manufacturers. This includes regulatory communication, vigilance reporting, and ongoing compliance oversight.
Importation Program
We design and manage your importation strategy, including annual program preparation, submission to the MIP, and coordination with local partners to secure uninterrupted market access.
Post-Market Surveillance (PMS & Vigilance)
We implement and operate your PMS system in Algeria, including incident reporting, trend analysis, field actions, and regulatory follow-up to ensure your products remain compliant throughout their lifecycle.
Import Permit Management
We handle the full process of obtaining import permits for medical devices, software products, and related equipment, ensuring rapid approvals and efficient market entry.
Training Offer
One-day masterclass covers the critical requirements of Executive Decree and the new 2025 decrees regarding establishment licensing and serialization. We provide a step-by-step guide to securing your "Décision d'Homologation" and navigating the technical visa process for seamless importation.
Additional Services
We provide tailored support including labelling compliance, technical file review, distributor qualification, quality system alignment, and strategic consultation for market access and expansion.
Latest Updates
Stay informed with the latest developments impacting medical device and in vitro diagnostic regulations in Algeria.
This section highlights key updates from the ANPP and MIP, new regulatory requirements, guidance revisions, standards updates, and important announcements to help you keep your compliance strategy aligned with the evolving Algerian regulatory framework.
