We had over 300 models of products on offer. 3 and 61 of our products had been certified as Class III and Class II medical devices in China, respectively, and our key products had received FDA approvals for 7 products, CE Marks for 21 products and MDSAP recognitions for 11 products. We have also developed a robust new product pipeline, including a laparoscopic surgical robot, which we expect to launch in 2024, if approved. As of the Latest Practicable Date, we had 19 product candidates, including 6 potential Class III medical devices and 13 potential Class II medical devices. As of the same date, we had two products that had received CE Marks and were in product registration process in China. With our comprehensive product portfolio, we aim to provide an “all-in-one” surgical toolkit that can make MIS safer, simpler, faster and more affordable.
Regulatory Compliance
EC, ISO 2001, ISO 13485, ISO 11135, (ETO stelirization); FDA-510(K) USA, CMDCAS Canada, GMP; Australia TGA, South Korea KFDA, Russia registration license, Brazil ANVISA and registration licenses in more than 20 other countries.
Quality Control
Testing, control and tracking guarantees quality: every single stapler has to pass a firing test before being placed to the market. Moreover, every single stapler and cartridge is photographed and stored for tracking, to ensure that every single staple has been correctly positioned.
Research & Development
R&D capability represents one of the most important engines driving our growth. We master a number of industry-leading core technologies, which together form a MISIA technology platform. Based on these technologies, we have developed various advanced and cost-effective products.