The NMPA granted Innovation Approvals to three gastroenterology and urology devices in June 2022:
- Ultrasound diagnostic equipment for gastrointestinal endoscopy
- Disposable cryoablation balloon catheter
- Laparoscopic surgery system
China NMPA Innovation Approval June – What are the Devices?
Ultrasound diagnostic equipment for gastrointestinal endoscopy
This product is an ultrasonic diagnostic equipment used in conjunction with gastrointestinal endoscopy. When in use, the ultrasonic probe enters the human digestive tract through the working channel of the digestive tract endoscope. The ultrasonic image processor outputs a control signal, and the probe driver drives the flexible shaft in the ultrasonic probe to rotate, and drives the front-end single-array ultrasonic transducer to perform mechanical ring scanning.
It transmits ultrasonic pulses to the inspection site, and after obtaining ultrasonic echo signals, the ultrasonic image processor processes the signals to present a two-dimensional black-and-white image on the display for ultrasonic diagnostic inspection.
The echo signal sensitivity of the ultrasonic probe of this product has been increased by 20%, and the relative bandwidth has reached 40%. On the basis of ensuring the spatial size of the probe, the echo signal is increased, the weak tissue signal is enhanced, the single-receive imaging accuracy can be guaranteed, and the detection depth and resolution of the ultrasonic probe with two frequencies (12MHz, 20MHz) are increased.
Disposable cryoablation balloon catheter
The product consists of a balloon, catheter body (vacuum outer tube, vacuum inner tube, return gas tube, intake tube, buffer tube, protection tube) and handle (handle seat, loop connection tube, vacuum connection tube, joint). Used in conjunction with a specific cryoablation device for adjuvant cryoablation after first transurethral resection of the bladder tumor (TURBt) in adult patients with T1 non-muscle invasive bladder cancer (NMIBC).
At present, there is no bladder tumor cryo-medical device in China. Domestic probe-type cryo-medical device products are limited to the application of solid tumors, and imported balloon-type cryo-medical device products are limited to the application of cardiovascular system.
The core technology of this product is that the catheter tip adopts an innovative balloon structure design, and the distal end of the balloon is concave, which can effectively freeze the side and distal end of the balloon. A buffer unit is also designed at the distal end of the balloon to increase product safety and facilitate the delivery of the catheter.
Laparoscopic surgery system
The product consists of a doctor console, a patient operating table, surgical instruments and accessories. The physician uses the master-slave control system to control the minimally invasive surgery and is used for laparoscopic surgery of the upper urinary tract in urology.
The doctor console of this product is the core part of the laparoscopic surgery system. The doctor controls the 3D endoscope and surgical instruments through two main hand controllers and a foot pedal device to achieve surgical operations on patients. The patient operating platform is the operating part of the laparoscopic surgical system, and its main function is to support surgical instruments and laparoscopic equipment.
With the operation of the main hand controller and foot pedal device on the doctor’s console, the robotic arm system performs corresponding operations. The joints of each robotic arm have multiple degrees of freedom of movement, which can improve the flexibility and precision of surgery and filter out Human hands tremble naturally. Surgical instruments assist in the completion of surgical cutting, suturing, clipping, etc.
Key Takeaways for Overseas Manufacturers
Overseas manufacturers need to bear in mind that:
- The NMPA gives overseas manufacturers equal opportunity for the fast-track channels. No difference as to the qualifications for domestic manufacturers vs. overseas ones
- “Conditional Approval” applies for urgently needed medical devices. NMPA issue the “Guideline on Conditional Approval for Medical Devices” on December 20, 2019. It specifies that devices and IVDs indicated for life-threatening illnesses can be granted “Conditional Approval”, if the benefits of the products overweigh the risks, and the manufacturers are committed to do further clinical research
- They can initiate innovation approval applications at same time when applying China Patent & Trade Office coverage. Application does not have to be made after getting the patent
- Having been granted “status” does not mean “approval”. With ‘front-of-queue’ priority, they still need to go through the normal review process.
China Med Device has translated “Innovation Approval Procedure for Medical Devices” and other official NMPA documents into English as a service for its clients. Email info@ChinaMedDevice.com for details or for any other related China NMPA Innovation Approval June 2022 questions.