Your Vision. Our Responsibility.
CERTIFICATIONS & COMPLIANCE
Every Malā’ product is developed, manufactured, and packaged under strict international quality systems giving our customers and business partners full confidence in safety, authenticity, and compliance.
We don’t just meet standards.
We align with the highest medical, ethical, and regional regulatory benchmarks in the industry.
CE Certification (Europe)
- Certified to meet EU health, safety, and environmental protection regulations for medical devices.
FDA Registration (USA)
- All Malā’ lenses and solutions are registered with the U.S. Food and Drug Administration, validating their global clinical compliance.
ISO 13485
- Our manufacturing partners follow ISO 13485:2016 the international standard for medical device production and quality control.
HALAL Certification
- All raw materials and production practices are free from haram substances, ensuring full compliance with Islamic requirements.
GCC & Local Regulatory Status
OMAN
- MOH Status In Final Registration
- Labeling Language Arabic + English
- Customs-Ready Yes
QATAR
- MOH Status Distributor Required
- Labeling Language Arabic + English
- Customs-Ready No ( TBD )
SAUDI ARABIA
- MOH Status Pre-SFDA File Prep
- Labeling Language Arabic + English
- Customs-Ready No ( In Progress )
UAE
- MOH Status Packaging Aligned
- Labeling Language Arabic + English
- Customs-Ready Yes (2025 Q2)
GCC & Local Regulatory Status
We maintain all documentation for every product sold, ensuring full transparency for regulatory checks, distributor onboarding, and retail approvals.