Regulatory Approval
Approved in 30+ countries across Europe, Asia, and Oceania.
Quality & Certifications
The Eyerising Myopia Management Device is registered in more than 30 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 30 countries across Europe, Asia, and Australasia. 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 30 countries across three regions. Approvals are obtained through the relevant national regulatory authority in each market.
- United Kingdom
- Turkey
- France
- Spain
- Portugal
- Norway
- Poland
- Italy
- Netherlands
- Israel
- Saudi Arabia
- Australia
- New Zealand
- Japan
- Malaysia
- Philippines
- Vietnam
- South Korea
- India
- Thailand
Regulatory Bodies
Eyerising International has obtained approval from the following national regulatory authorities.
CE Marking
Europe (EU/EEA)
Therapeutic Goods Administration
Australia
Medicines and Healthcare products Regulatory Agency
United Kingdom
Medsafe
New Zealand
Thai Medical Device and Medical Equipment Authority
Thailand
Medical Device Authority
Malaysia
Pharmaceuticals and Medical Devices Agency
Japan
Central Drugs Standard Control Organisation
India
Ministry of Food and Drug Safety
South Korea
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.