By Fineline Cube 
Gaush Meditech Ltd. (HKG: 2407) announced that its wholly‑owned subsidiary Gaush Tech Ltd. has been issued a Medical Device Registration Certificate by the Guangdong Provincial Medical Products Administration for its newly‑approved ophthalmic electrophysiological diagnostic system (Certificate No. Yue Xie Zhu Zhun 20252161439).
Product Overview
| Feature | Clinical Function | Typical Indications |
|---|---|---|
| Visual Evoked Potential (VEP) | Objective assessment of the optic nerve and entire visual pathway (retinal ganglion → visual cortex) | Intra‑operative monitoring during sellar‑region neurosurgery (pituitary adenoma, craniopharyngioma); patients unable to perform subjective acuity tests |
| Electroretinography (ERG) | Measures retinal photoreceptor and bipolar cell activity | Screening & diagnosis of retinal dystrophies, diabetic retinopathy, inherited retinal disease |
| Electrooculography (EOG) | Evaluates retinal pigment epithelium (RPE) and photoreceptor health | Differential diagnosis of retinitis pigmentosa, Best disease, other RPE‑related disorders |
The system combines all three modalities into a single, compact platform, enabling comprehensive, objective electrophysiological evaluation of both anterior (optic nerve) and posterior (retina, RPE) visual structures.
Regulatory Milestone
- Authority: Guangdong Provincial Medical Products Administration (GPMPA)
- Certificate Number: Yue Xie Zhu Zhun 20252161439
- Scope: Class II medical device – ophthalmic electrophysiology diagnostics for hospital and specialty eye‑care settings across mainland China.
Market & Strategic Implications
- Addressable Market: China’s ophthalmic diagnostics market is projected to exceed CNY 120 billion by 2028, driven by an aging population and rising prevalence of retinal disease.
- Competitive Edge: Integrated VEP/ERG/EOG platform reduces equipment footprint and workflow complexity, offering a single‑point solution versus fragmented multi‑vendor setups.
- Revenue Outlook: Gaush Meditech expects the device to contribute ≈ 15 % of FY 2026 total revenue, with initial sales targeting tertiary eye hospitals in Guangdong, followed by national rollout.
- Strategic Fit: The approval aligns with Gaush Meditech’s broader strategy to expand its medical‑device portfolio beyond its core pharmaceutical business, leveraging existing distribution channels and after‑sales service networks.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the commercial launch, market potential, and financial impact of Gaush Tech’s ophthalmic electrophysiology system. Actual results may differ due to risks including regulatory changes, market adoption rates, and competitive dynamics.-Fineline Info & Tech