Professional Empowerment Series (43): Hahe Bio Supports Euclid's "Orthokeratology Rigid Gas Permeable Contact Lens" in Securing China's Class III Medical Device Registration Certificate
Euclid
Orthokeratology Lens Manufacturer
Haihe Bio provided biocompatibility testing services for Euclid (Suzhou) Medical Technology Co., Ltd.'s self-developed "Rigid Gas Permeable Contact Lens for Orthokeratology" product, ensuring compliance with biosafety standards and facilitating its successful registration approval by the China National Medical Products Administration (NMPA). Throughout the project, Haihe Bio's technical team demonstrated exceptional professionalism and efficient work capability, earning the trust and recognition of the client.
Orthokeratology Rigid Gas-Permeable Contact Lenses (commonly known as OK lenses) are innovative medical devices that achieve clear daytime vision through overnight wear. As Class III medical devices that directly contact the cornea, their biological safety is a crucial aspect during the product registration process. To address this core challenge, Euclid, a global leader in the contact lens industry, has chosen to collaborate deeply with Haihe Biotechnology.
Haihe Bio, with its twenty years of profound accumulation and professional strength in the field of medical device testing, has joined hands with Euclid to jointly overcome a series of challenges in biological safety evaluation.The technical team, in strict accordance with the GB/T 16886 series of standards and based on the characteristics of the product, designed and implemented a systematic biological evaluation plan. The core work included conducting subacute and subchronic systemic toxicity tests (implantation method), scientifically evaluating the biocompatibility and toxicological responses of the material during short-term and medium- to long-term use through systematic implantation studies in rat models, providing critical and reliable data support for the clinical safety of the product.
During the project execution, both teams demonstrated highly efficient collaboration. HAIHE BIO ensured the accuracy and reproducibility of experimental data through rigorous and standardized operations. With its deep product knowledge and efficient feedback mechanism, Euclid provided strong support for the smooth progress of the project, ensuring high-quality completion of the testing phase while establishing a solid relationship of mutual trust.
Haihe Bio and Euclid's strategic collaboration has achieved a key breakthrough in synergistic innovation within the high-end ophthalmology field. Building on this foundation, both parties will continue to deepen their strategic partnership, jointly lead industry standards and innovation, and contribute value to the cause of eye health.
Euclid Group
Euclid Group is a leading R&D and manufacturing enterprise in the field of corneal contact lenses and a global frontrunner in vision care products. The Euclid China R&D and production base project was established in the Jiangsu Medical Device Park in August 2021, with a total investment of 200 million yuan. It is the first global production base built by Euclid Group outside its U.S. headquarters and also the first foreign-funded orthokeratology lens company to enter the Chinese market.
Engaged in standardization and customized testing and monitoring services for medical devices, pharmaceuticals, drug-device combination products, and biopharmaceutical environments, Haihe Biotechnology's medical device and pharmaceutical testing business, particularly in medical device testing, holds advanced domestic and international testing standard-related qualifications. It can achieve a single test that meets the requirements of different regions and markets.
ToCustomers provide full lifecycle regulatory policy consultation, registration certification guidance, post-market adverse event handling, technology transfer, training, and related services for medical devices, pharmaceuticals, and combination products in China, the United States, the European Union, Brazil, Canada, and Southeast Asian countries.
Haihe Biotechnology's Medical Device Contract Development and Manufacturing Platform is established in accordance with China's NMPA Good Manufacturing Practice for Medical Devices, U.S. FDA QSR, and ISO13485 standards. It serves as a platform for medical device industry-academia collaboration, medical-engineering transformation, and startup teams, undertaking custom medical device product development, outsourced R&D, and outsourced production. The production capabilities cover IVD diagnostic reagents, IVD diagnostic equipment, medical devices, and high-value surgical consumables.
