Mr. Wu Haizhou, General Manager of Yaoshi Medical; Mr. Yin Yong, Director of SGS Connectivity & Products Medical Devices for East China North; Mr. Luo Heng, Director of SGS Connectivity & Products Cybersecurity for China; along with representatives from all parties, jointly attended this certification ceremony.
In response to the urgent need for fundus screening driven by aging populations and the high incidence of chronic diseases, Yaoshi Medical leads the high-end ophthalmology赛道 with its self-developed electronic scanning laser ophthalmoscope (SLO) ultra-wide-angle ophthalmoscope. Meanwhile, with the deep integration of medical digitalization and artificial intelligence technology, cybersecurity has evolved from an auxiliary consideration to a core safety pillar in the full lifecycle management of medical devices.
IECEE CB Certification — The “Passport” for Global Product Deployment
As a global mutual recognition mechanism under the International Electrotechnical Commission (IECEE) system, CB certification serves as a key credential for medical devices entering international markets. By unifying technical language and standard recognition, this mechanism significantly simplifies the market access pathways for key target markets such as the European Union, the United States, and Japan. It not only effectively avoids cumbersome repetitive testing but also substantially shortens the time-to-market for manufacturers in multi-country registration processes and greatly reduces compliance-related economic costs.
Cybersecurity Assessment Process: Comprehensive Security Checks Covering the Product Lifecycle
In this project, SGS strictly adhered to the principle of assessment independence, conducting a systematic review of the Yetsea 300 series products, ranging from technical verification to system audits. On the technical front, the SGS team performed threat modeling and risk assessment, and examined the underlying security risks of the device through penetration testing, vulnerability scanning, code auditing, and software bill of materials. On the process front, the SGS team systematically conducted a compliance review of Yaoshi Medical’s cybersecurity management system documents and the actual activity records of the Yetsea 300 product. It verified that security activities have been integrated into all aspects, including quality requirements, secure development, testing and verification, as well as post-market vulnerability monitoring and emergency response. After confirming that all records met the requirements of the IEC 81001-5-1 standard, the cybersecurity CB test certificate was formally issued.
Group photo of representatives from all parties at the certification ceremony
Mr. Yin Yong, Director of SGS Connectivity & Products Medical Devices for East China North, stated that Yaoshi Medical’s successful passing of SGS’s rigorous audit and obtaining multiple CB certificates fully demonstrates that the safety performance and technical indicators of Yaoshi Medical’s SLO products have reached international IEC standards, highlighting the hardcore quality and compliance strength of domestically produced high-end ophthalmic equipment. As an “international passport” for products entering global markets, the CB certificate can significantly reduce the costs of multi-country certification overseas and shorten the market access cycle, further accelerating the expansion of overseas ophthalmic medical markets. We look forward to using this certification as an opportunity to deepen strategic cooperation with Yaoshi Medical. Leveraging SGS’s global network and technical resources, we will continue to provide Yaoshi Medical with one-stop solutions ranging from product testing and compliance certification to international market access, jointly promoting the high-quality, global development of domestically produced ophthalmic medical equipment.
Mr. Luo Heng, Director of SGS Connectivity & Products Cybersecurity for China, stated that congratulations to Yaoshi Medical for the successful CB certification of its Yetsea 300 series products and for obtaining multiple CB certificates. Yaoshi Medical and SGS collaborated efficiently and closely throughout the certification project. This achievement fully confirms Yaoshi Medical’s execution capability in strictly adhering to international standards, as well as its product quality and corporate quality management capabilities. It also reflects SGS’s professional expertise in the cybersecurity field. In the future, SGS will continue to provide compliance verification assurance for Yaoshi Medical and more medical device companies based on objective technical evidence, helping enterprises confidently navigate global regulatory challenges.