This year, the number of innovative medical devices on the market has increased to 5, and another domestic first innovation has emerged in Shanghai | Medical Devices | Domestic First
Another innovative medical device from Shanghai has been approved for market launch. The Shanghai Municipal Medical Products Administration announced today that it has approved the registration application for the innovative medical device produced by Shanghai Keci Medical Technology Co., Ltd., which is a disposable esophageal traction balloon catheter. This is the second Class II innovative medical device approved for market in Shanghai this year, increasing the number of innovative medical devices approved for market in Shanghai to 5, including 3 Class III innovative medical devices.
This product consists of a stretchable balloon component, a sheath kit, a sheath assist device, a three-way valve, and an extension tube, suitable for stretchable esophagus during cardiac ablation surgery. This innovative product is the first esophageal protection device in China that can be used through nasal approach. Its application can prevent the risk of esophageal burns that may occur during ablation surgery.
The fruitful research and development cannot be separated from institutional innovation.
The drug marketing license holder system and medical device registrant system, which Shanghai has pioneered nationwide, have relaxed the constraints on registration and production, allowing scientific research forces to break through environmental protection and land resource constraints. They are "light hearted" and entrust production enterprises to produce, focusing on innovation without worrying about "selling young crops". This has laid a solid foundation for a large number of innovation teams to gather in Shanghai.
The Jiefang Daily Shangguan News reporter learned that the disposable esophageal traction balloon catheter approved for marketing this time is completely independently developed by Keci Medical, and has obtained patent authorization in the United States, Europe, and Japan. It has been listed through the medical device registration system and entrusted to another subsidiary under the same group company, Kegang Medical, for production, greatly reducing the cost of innovative product launch.
![This year, the number of innovative medical devices on the market has increased to 5, and another domestic first innovation has emerged in Shanghai | Medical Devices | Domestic First](https://a5qu.com/upload/images/693333c0050b663744a4bbddbad7e84a.jpg)
In recent years, the field of medical device innovation in Shanghai has ushered in a "harvest period", with a total of 81 medical device products entering the national innovation review channel and 36 Class III innovative medical devices approved for listing.
Since the beginning of this year, the Shanghai Drug Administration has established a service innovation leadership group, launched 19 measures to strengthen integrated innovation and continuously optimize the business environment, formulated local standards for the "Shanghai Second Class Medical Device Registration Service Specification", issued the "Shanghai Innovative Medical Device Registration Guidance Service Work Specification", and carried out in-depth actions to continuously optimize medical device registration guidance services.
With the help of 12 biopharmaceutical product registration guidance service stations established throughout the city, the Shanghai drug regulatory department has carried out multiple "order based" training and "face-to-face" Q&A activities, providing personalized and convenient policy guidance and follow-up services to guide enterprises to avoid detours. In the first half of this year, 166 new Class II medical device registration certificates were approved in the city, a year-on-year increase of 97.6%; The overall registration cycle has been shortened by 8.2% year-on-year.