Tuopai Medical Secures CE Certification Under EU MDR for Its OCT Devices, Officially Enters European Market Amid IPO Filing
TowardPi
High-end Ophthalmic Medical Device Developer
TowardPi Medical has recently officially passed the European Union (CE Certification under the EU's New MDR RegulationsTowardPi's self-developed and produced new generation OCT product will enter the European market.Unobstructed!
MDR: The EU's New Medical Device RegulationThe new MDR regulations have significantly raised the bar for medical device entry into the European market, substantially slowing down the application process for global manufacturers seeking access, with far-reaching impacts.
2023 ESCRS TowardPi Medical Booth
TowardPi's CE certification application came right after the MDR new regulations took effect. For TowardPi Medical, which is applying for the first time, the difficulty is imaginable.Adhering to the principle of following the highest standards and execution norms, and after undergoing stringent rounds of EU reviews targeting both the company and its products, TowardPi Medical has now successfully become one of the few new Chinese medical enterprises to pass under the new MDR regulations.Successfully obtained the pass to compete with international brands in the European market.
At the same time, during the application for certification, they did not forget to actively prepare.TowardPi has successfully signed up 17 distributors in the European market, covering 22 countries and regions. In key battlegrounds for world-leading ophthalmic brands such as France and Italy, TowardPi has attracted highly reputable local OCT distributors with experience handling thousands of devices to join its network, taking charge of local channel management and after-sales service.
TowardPi Booth at the 2023 World OCT Conference in Rome, Italy
The ophthalmic OCT device manufactured by TowardPi, a Chinese company, is even more expensive than many classic international brands. However, due to its outstanding performance advantages, users still flock to it.As of the press release date, commercial orders for TowardPi's self-developed and self-manufactured full-field swept-source OCT devices from Europe have covered France, Italy, Germany, Switzerland, the Netherlands, Spain, Greece, Turkey, Serbia, and more, with the numbers still growing continuously.
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