Another Chinese Ophthalmic Surgical Knife Approved: What Are Companies Competing On in This Category?

In October 2026, a single-use sterile ophthalmic surgical knife developed by Aili Medical Technology (Suzhou) Co., Ltd. received a Class II medical device registration certificate from the Jiangsu Medical Products Administration.

The registration number is Jiangsu MPA 20262161511, with the certificate valid through October 23, 2031. Its intended use is stated as: “for cutting or puncturing ocular tissue during clinical ophthalmic surgery.”

The product consists of a blade, handle and blade holder. It is sterilized with ethylene oxide and intended for single use.

Ophthalmic surgical knives are already a mature category of medical devices. As the number of domestic products continues to increase, what opportunities remain for technological innovation in this seemingly simple segment, and what are Chinese manufacturers actually competing on?

Where Does the Technical Challenge Lie in an Ophthalmic Surgical Knife?

Ophthalmic microsurgeries such as cataract surgery place relatively high requirements on the shape, size and stability of surgical incisions.

The sharpness of the blade, puncture resistance, cutting-edge geometry and batch-to-batch consistency can all affect the surgeon’s operating experience.

In cataract surgery, for example, the corneal incision serves as the entry point for surgical instruments into the eye. Its shape and sealing performance are also related to postoperative recovery. Surgeons therefore need stable and controllable cutting performance across different tissue conditions.

Aili Medical’s newly registered product uses a stainless-steel blade. According to the company, it developed a grinding-force model for miniature surgical blades during R&D and sought to improve blade performance through cutting-edge angle design and precision grinding processes.

The product is available in multiple models and specifications, including 1.6–3.0 mm main-incision knives, side-port knives with different angles, as well as crescent tunnel knives and spear-point knives, covering different incision configurations and procedural requirements.

For precision consumables of this type, the technical challenge is not simply producing a sufficiently sharp blade. Manufacturers must also maintain stable dimensions, edge geometry and mechanical performance during mass production.

Micron-level manufacturing capability ultimately needs to translate into consistent product quality.

Domestic Supply Is Increasing, but Registration Is Only the Starting Point

Public registration information shows that there are now nearly 20 domestic registrants of ophthalmic surgical knives in China.

Selected domestically registered ophthalmic surgical knives

The intended-use descriptions for these products are not identical.

The registered intended use of Gausch Precision Ltd. is specifically limited to the main limbal incision, while Aili Medical’s product is registered for cutting or puncturing ocular tissue. The surgical scenarios covered by the two registrations are therefore different.

Registration certificates held by Jiangsu Beifeng Medical Technology Co., Ltd. have appeared in consumable procurement records from the Second Affiliated Hospital of Fujian Medical University and Nan’an Hospital.

Shaoxing Shouren Medical Health & Technology Co., LTD received registration for an ophthalmic surgical knife in October 2026.

Registration information reflects the supply-side product landscape. Publicly available information on hospital access and surgeon feedback varies considerably between companies.

Regulators Are Already Applying Another Set of Screening Criteria

On August 26, 2026, China’s National Medical Products Administration ordered the suspension of the import, distribution and use of an ophthalmic surgical knife manufactured by Laurus Optics Limited, registration number NMPA Registration (HK/MO/TW) 20252160016.

The action followed a remote inspection that identified serious deficiencies in the company’s quality management system, including issues involving the performance of key personnel, design and development, production management, quality control and product release. The regulator determined that the product presented potential quality and safety risks.

There is no causal relationship between this regulatory action and Aili Medical’s new registration.

Placed side by side, however, the two developments point to a clear issue for precision ophthalmic consumables: regulatory scrutiny is extending beyond whether a product holds a registration certificate to whether the underlying quality management system operates reliably.

The areas cited in the Laurus Optics case — key personnel, design and development, production management, quality control and product release — are also closely related to the batch-to-batch consistency of precision surgical knives.

The clinical space left by suspended imported products is real. But for domestic manufacturers to capture that opportunity, hospitals and surgeons will need confidence that product performance remains predictable over repeated use across different batches.

EyeFuture Observation

Competition in ophthalmic surgical knives is increasingly centered on whose consistency can withstand scrutiny.

Aili Medical’s registration certificate provides market access, while the precision-manufacturing investments described in its company materials are directionally aligned with this requirement. However, manufacturing-process descriptions still need to be followed by evidence from real-world hospital use.

Several specific questions are worth tracking in the next stage of this market.

For domestic products that have already entered hospital procurement, such as those from Jiangsu Beifeng, how do surgeons evaluate incision quality and batch consistency?

Will newly registered companies such as Aili Medical and Shouren launch or publish comparative clinical data against reference products over the next 12–18 months?

And will regulatory inspections of quality management systems become a more routine part of post-registration supervision in this category?

EyeFuture will continue to follow the development of China’s domestic supply chain for precision ophthalmic consumables and the accumulation of supporting clinical evidence.

Companies with relevant product data or clinical feedback are welcome to contact us.

November 5, 2026