Regulatory Approval
Approved in 40+ countries across Europe, the Middle East, Asia-Pacific, and Latin America.
Quality & Certifications
The Eyerising Myopia Management Device is registered in more than 40 markets worldwide and is manufactured under an ISO 13485:2016 certified quality management system. Regulatory approvals confirm the device's compliance with international quality and safety standards.
The Eyerising Myopia Management Device has been approved for use by health authorities in more than 40 countries across Europe, the Middle East, Asia-Pacific, and Latin America. Each approval means the device has successfully met the safety, quality, and performance standards set by local medical regulators.
ISO 13485:2016 Certified
Full compliance with ISO 13485:2016 - the international standard for quality management systems specific to medical device design, manufacture, and distribution. Certification demonstrates a commitment to consistent product safety and quality.
Class IIa Medical Device
Classified as a Class IIa medical device in most markets, reflecting the device's low-to-moderate risk profile. This classification requires conformity assessment by a notified body prior to market authorisation.
ARTG 412752 (Australia)
Listed on the Australian Register of Therapeutic Goods under ARTG entry 412752. Approved by the Therapeutic Goods Administration (TGA) for the management of myopia progression in children and adolescents.
Global Approvals
The Eyerising device has received regulatory approval in over 40 countries across four regions. Approvals are obtained through the relevant national regulatory authority in each market.
- European Union
- United Kingdom
- Turkey
- United Arab Emirates
- Saudi Arabia
- Australia
- New Zealand
- Malaysia
- Vietnam
- Hong Kong
- Colombia
- Ecuador
Regulatory Bodies
Eyerising International has obtained approval from the following national regulatory authorities.
CE Marking
European Union
Medicines and Healthcare products Regulatory Agency
United Kingdom
Turkish Medicines and Medical Devices Agency
Turkey
Ministry of Health and Prevention
United Arab Emirates
Saudi Food and Drug Authority
Saudi Arabia
Therapeutic Goods Administration
Australia
Medsafe
New Zealand
Medical Device Authority
Malaysia
Drug Administration of Vietnam
Vietnam
Medical Device Division, Department of Health
Hong Kong
National Food and Drug Surveillance Institute
Colombia
National Agency for Health Regulation, Control and Surveillance
Ecuador
Regulatory Enquiries
For questions about regulatory status in a specific market, or to request documentation for distribution or clinical use, please contact our regulatory affairs team.