On August 16th 2024, Beijing Tinavi Medical Technology Co., Ltd. announced that its orthopedic surgery navigation positioning system and orthopedic surgery navigation positioning toolkit have recently obtained CE MDR certification. The certified products can be sold in EU countries and countries that recognize EU CE certification. This is a milestone progress made by Tinavi in expanding its overseas market, marking the official opening of the door to the EU market for the TiRobot orthopedic surgical robot product which has the highest market share in the domestic market.

CE Certification is the "passport" for products in the EU market, and a key credential for products to enter the EU market and achieve free circulation within the EU. The CE certification under the MDR regulatory framework is one of the essential requirements for market access in the EU medical device market. It requires strict clinical evaluation of the safety and effectiveness of medical devices to ensure that they meet the quality standards and legal requirements of the EU market, in order to protect public health and patient safety.

TiRobot ® orthopedic surgical robot is the world's first and currently the only robot product that can perform orthopedic surgeries in the three major fields of spine, joint, and trauma on the same device. The product can enter the corresponding functional modules according to clinical surgical requirements, achieving "one machine, three uses". This TiRobot ® spinal function of the surgical robot has obtained CE certification this time, which could be used for navigation and positioning of surgical instruments or implants in open or percutaneous spinal surgery.

TiRobot ® technological innovation advantages and clinical application effects of orthopedic surgical robots have been fully tested in the domestic market for more than a decade, and have long occupied the main share of the domestic orthopedic surgical robot market. TiRobot® orthopedic surgical robots have performed over 24000 surgeries in 2023, an increase of nearly 90% compared to the same period last year. As of April this year, the company's orthopedic surgical robots have been routinely applied in more than 200 medical institutions in China, with a total of over 70000 surgeries performed.

According to Global Data data, Europe is the second largest revenue generating market for surgical robots in the world, second only to North America. The market size for surgical robots was $1.5 billion in 2021, with an expected compound annual growth rate of 7.5% from 2021 to 2030. The overall strong public awareness of healthcare, the increasing elderly population, and the number of surgical patients make the European surgical robot market have the potential for accelerated growth, which also contributes to the success of TiRobot providing broad development space for high-quality domestic surgical robot products to explore overseas markets.

Ms. Chen Zhaohui, Vice President of the Medical and Health Services Department of TÜV SÜD Greater China Group, presented a certificate to Tinavi and stated, "Surgical robots integrate various modern high-tech technologies such as medical and artificial intelligence, with high technical barriers, high precision, and high added value. Tinavi orthopedic surgical robots have successfully passed a series of rigorous product safety and effectiveness evaluations with their excellent technology and quality, as well as rich and profound clinical application accumulation. The issuance of this certificate marks TiRobot orthopedic surgical robots fully comply with relevant EU laws, regulations, and standard requirements, demonstrating their leading position in the international orthopedic surgical robot field. We look forward to TiRobot® Can bring more precise and safe services and experiences to the EU orthopedic medical market.

Xu Jin, General Manager of Tinavi, said, "We are honored to receive the first CE certificate for surgical robots issued by TÜV SÜD in China that complies with MDR regulations. The international version of the TiRobot® II orthopedic surgical robot has already obtained the CSA certification commonly used in North America. This CE certification is another important achievement of the company's internationalization strategy, which lays a solid foundation for Tinavi to accelerate its overseas market layout in the future. It also means that domestic surgical robots have the international leading technological level and the strength to participate in global market competition