Recently, the British Standards Institution (BSI) officially approved Infer Vision’s TB UKCA certification, which is the first TB UKCA certification approved for a Chinese AI medical company. As of July 2023, Infer Vision is the first and only Chinese AI medical technology company in the world whose products have received regulatory approvals in the five major markets of China, the US, the EU, the UK, and Japan, gaining access to the vast majority of the world’s major healthcare markets, and with its products covering over 1,000 healthcare organizations in more than 20 countries around the world.
Less than two weeks ago, Infer Vision’s DR Chest Disease Assisted Screening product officially passed the MDR CE certification, which, up to now, is the first MDR CE certification passed by a Chinese AI healthcare company globally that focuses on TB screening and diagnosis. Together with Infer Vision’s current UKCA certification for its TB AI products, Infer Vision’s TB AI products have now received dual certification from the EU’s MDR CE and the UK’s UKCA.
As medical products are related to human life and health, they are subject to extremely stringent regulatory measures in all countries around the world, and the AI medical industry is also characterized by a high barrier to entry. UKCA (UK Conformity Assessment) is a product certification system launched by the UK government to ensure that products sold in the UK market comply with the relevant technical standards and requirements. The UK is considered one of the major markets for medical devices globally due to its highly developed healthcare system, innovative R&D environment, international cooperation and exports, as well as government support and regulation, which makes the UK an important market for attracting both domestic and foreign manufacturers and suppliers of medical devices, and occupies an important position in the global medical device market.
From 2021, the UK officially leaves the European Union and exits the European Single Market and Customs Union. As a result, for products planned to be sold in the UK market, they need to comply with the new UK market access requirements, and UKCA certification has become a necessary condition for legally selling products in the UK market. By taking the lead in obtaining UKCA certification for tuberculosis products, presumptive has already grabbed a head start in the UK market, laying a solid foundation for the subsequent commercialization process.
Not only the UKCA certification in the UK market, Infer Vision has previously been successfully included in the commercial service catalog of the National Healthcare System in the UK, and has established offices in both London and Birmingham to further penetrate into the UK and other overseas markets.
As early as 2021, Infer Vision’s self-developed InferRead CT Lung was included in the UK’s NHS Shared Commercial Services (NHS SBS) framework, providing early screening testing services for lung nodules for UK patients and helping the NHS to reduce the cost of lung cancer prevention and treatment.In May 2023, Infer Vision’s AI solution was once again selected for the NHS SBS framework. The successive renewals of NHS SBS are of great significance to Infer Vision, not only does it mean that the solution is recognized and affirmed by the NHS, but also that our services and deployment capabilities have stood the test of the international market.
In 2020, Infer Vision’s AI-assisted diagnostic products have been awarded the EU CE, US FDA, Japan PMDA, China NMPA, and UKCA medical device registration certificates, making Infer Vision the world’s first, and still the only, Chinese AI medical technology company to have received regulatory approval from all five healthcare markets and authoritative organizations, officially opening the “Five Certificates in One” process. Opening the “five certificates complete” era, prying the global AI medical market! Behind this is a huge investment in research and development, which is also the best proof of the ability of Nano’s products. Infer Vision’s “five certificates” cover the world’s most important markets with the highest level of medical care and the most stringent access audits, and also provide an important reference for market access in other countries and regions around the world.
Infer Vision has always been the main force in the internationalization of China’s AI medical enterprises, and since the successive establishment of Infer Vision’s Japanese, North American, and European teams in 2018, its products have been widely acclaimed in the international arena. What’s more, Infer Vision is one of the few AI medical companies that have business teams overseas and really carry out international cooperation, and it has continued to make new progress and good news in product registration, overseas commercialization, and international standard development.