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.
ARTG 412752 (Australia)
Listed on the Australian Register of Therapeutic Goods under ARTG entry 412752 as a home-use medical device that can slow the progression of myopia in myopic children aged 3 to 16 years old.
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 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.