Introduction

In accordance with the requirements outlined in the 2023 National Medical Device Registration Review Guidelines, the Device Center has undertaken the revision of the "Guidelines for Technical Review of Ophthalmic Phacoemulsification and Vitrectomy Equipment and Accessories Registration (2023 Revised Edition)." Following extensive research and discussion, a draft for soliciting opinions has been developed and will be open for public feedback online.

01 Advantages

EastPoint Innovation possesses the Alcon Constellation Ultrasonic Emulsification and Vitrectomy Surgery Integrated Machine (including laser), which fulfills the prerequisites for pre-market research and comparative verification of similar products. Leveraging East Point's comprehensive solution for animal ophthalmology surgery, we deliver high-quality laboratory services to our customers.

02 About EastPoint

EastPoint Innovation Center Co., Ltd., operating as an independent third-party service platform driven by innovative technology for medical device research and development, stands as an advanced and leading domestic platform. Focused on functional and safety evaluations of large animal experimental medical devices, biological evaluations of medical devices, animal testing in medicine, material analysis and testing, clinical research (CRO), and registration consulting, we serve as an integrated comprehensive service platform for medical new technology training and exchange. Tailoring a personalized integrated service model from preclinical to clinical research and registration consultation, based on the unique characteristics of our customers and their medical device products, we aim to enhance the provision of basic preclinical research data, clinical research, and connection services for registration and application.