Certifications & Compliance

Certifications & Compliance

Our Commitment to Quality and Safety

At Smile Tech Innovations (STI) , quality is the foundation of everything we do. Operating from our facilities in the Tangier and Casablanca Free Zones, we adhere to the highest international standards to ensure that every product we manufacture and distribute meets rigorous safety and performance requirements.

ISO 13485:2016 Certified
We are proud to hold ISO 13485:2016 certification for our Quality Management System . This international standard demonstrates our commitment to the design, production, and distribution of safe and effective medical devices. It ensures that our processes are continuously monitored, improved, and aligned with global regulatory expectations .

CE Marking & European Compliance
Our products are manufactured in accordance with European Medical Device Regulation (MDR) and bear the CE mark , signifying conformity with health, safety, and environmental standards required for the European market .

Moroccan Market Authorization (AMMS)
As a Morocco-based company, we are fully compliant with the requirements of the Moroccan Directorate of Medicine and Pharmacy (DMP). We hold the necessary Marketing Authorization (AMMS) for our products, ensuring full legal compliance for distribution across the Kingdom . Our status as a local operator allows us to navigate the regulatory landscape efficiently, serving as a trusted partner for international brands seeking access to the Moroccan and broader African markets.

Regulatory Recognition
Moroccan health authorities recognize the equivalence of key international certifications, including CE marking and FDA approval . This recognition allows STI to leverage its certifications to facilitate market access for our partners, ensuring that our products meet the stringent requirements of health systems worldwide.