CHENNAI, India – August 25, 2025 — Morulaa HealthTech Pvt. Ltd. announced that Eyeonic, a leading innovator in ophthalmic diagnostics, has received CDSCO Class A registration from the Central Drugs Standard Control Organization, part of the Ministry of Health and Family Welfare of India. The approval covers Eyeonic’s online visual field test, now officially registered under the India medical device registration framework.
With a population of over 1.4 billion and significant need for scalable vision care, India represents a critical market for US and European manufacturers seeking compliant entry for their medical devices. Eyeonic’s cloud-based technology delivers reliable, hospital-grade visual field testing through standard web browsers—no proprietary hardware required—enabling faster adoption under India’s CDSCO approval process.
Regulatory Approval Highlights
Morulaa HealthTech Pvt. Ltd., a specialist medical device consultant in India, facilitated Eyeonic’s successful journey through India’s Medical Device Rules, 2017 (MDR 2017). As an experienced Indian regulatory consultant, Morulaa supports global companies—including manufacturers from the USA and Europe—through the CDSCO registration process, including regulatory filings, compliance documentation, and CDSCO import license application via Form MD-14/MD-15.
Their expert guidance ensured Eyeonic met CDSCO’s stringent requirements for Class A device registration, leading to nationwide market approval and distributor onboarding.
Trusted by India’s Leading Eye Institutions
To ensure clinical relevance and applicability in the Indian market, Eyeonic’s browser-based perimetry system was piloted across several prominent eye hospitals. The All India Institute of Medical Sciences (AIIMS) in New Delhi provided regulatory and clinical guidance, while the LV Prasad Eye Institute conducted field validation and diagnostic testing. Dr. Shroff’s Charity Eye Hospital supported implementation in clinical practice.
In parallel, Eyeonic’s authorized distributor and CDSCO-licensed partner, facilitated in-country logistics and Indian market access. These collaborations significantly strengthened Eyeonic’s foothold in India’s vision care sector.
Affordable, Accessible, and Hardware-Free Eyecare
Eyeonic’s hardware-free ophthalmic diagnostic platform eliminates the need for conventional, costly visual field analyzers. Designed for rapid deployment across diverse healthcare settings, the system empowers clinicians to conduct CDSCO-compliant diagnostics using just a tablet or laptop. This makes it a vital tool for screening in underserved rural regions.
“Our goal is to make visual field testing accessible for everyone, especially those who previously had no access to this essential service. Early detection saves sight,” said a spokesperson from Eyeonic.
The device’s approval under India’s CDSCO registration scheme highlights the country’s growing role in the global digital health landscape.
About Eyeonic
Eyeonic is an Australia-based health technology company pioneering digital eyecare diagnostics. Their flagship browser-based visual field test delivers accurate perimetry without proprietary hardware—enabling scalable vision screening across global markets. Learn more at www.eyeonic.com.au.
About Morulaa
Morulaa HealthTech is a regulatory consulting firm in India specializing in CDSCO registration, CDSCO approval process navigation, import licensing (Form MD-14/MD-15), and Indian distributor onboarding. Trusted by manufacturers across Europe, the United States, and Asia, Morulaa enables fast-track medical device registration in India under MDR 2017. Visit www.morulaa.com for expert support from an experienced CDSCO consultant in India. Also follow us on Facebook, LinkedIn, and Twitter
Forward-looking Statements
This document contains forward-looking statements regarding plans, expectations, and future events. Forward-looking statements involve risks and uncertainties that could cause actual outcomes to differ. Statements are based on current information as of this release date and are not guarantees of future performance.