Three Medical Devices Receive NMPA Innovation Approval

The NMPA granted Innovation Approval to three medical devices in September 2021:

• Dental implant surgery navigation and positioning equipment
• Ultrasonic diagnostic equipment for endoscope
• Transcatheter aortic valve and retrievable delivery system

NMPA issued the list of 121 innovation approvals since the pathway established in 2014. For an English copy of the list, please email us at info@ChinaMedDevice.com

To download the NMPA Innovation Approval Procedure please click HERE

Why They Are Approved

NMPA gives explanations for each approval:

Dental implant surgery navigation and positioning equipment

“The product consists of a motor holder, an implant cart, a vision and display cart, and surgical navigation software; it is used in conjunction with supporting accessories for the navigation and positioning of implants during adult oral implant surgery.

The core technologies include spatial mapping, surgical path planning and surgical path positioning, and have patents for the registration method and electronic equipment of dental implant surgery visual navigation, implant mobile phone holding device, dental implant surgery positioning device and surgical path planning method. The clinical advantage of this product is mainly to ensure the accuracy of implant placement.”

Ultrasonic diagnostic equipment for endoscope

“This product is composed of a host, a probe driver, a small ultrasound probe, a foot switch, and a trolley. It is combined with the upper gastrointestinal endoscope and used for ultrasonic diagnostic examination of the upper gastrointestinal tract. This product is based on the direct observation of the lesions on the mucosal surface of the digestive tract with the conventional endoscope, and the ultrasound probe can be used to perform ultrasound scanning observation on the submucosal tissues of the lesion, which enhances the diagnostic effect of conventional endoscopy. Not only can the surface image of the human digestive tract wall be obtained, but also the tomographic images of the surrounding organs can be obtained at the same time, and multiple information can be obtained through one inspection.

The product adopts self-developed high-frequency ultrasound hardware, miniature imaging probes, high-performance software architecture and new image processing technologies, which can greatly improve the quality of endoscopic ultrasound images and help to find early gastrointestinal tumors and improve the survival rate of patients.”

Transcatheter aortic valve and retrievable delivery system

“The product is composed of valve, delivery system, loading tool and guide wire. The valve is made up of three leaflets (bovine pericardium), skirt (PET), clip (nickel-titanium) and self-expanding stent (nickel-titanium) sutured by sutures (PTFE). The delivery system is mainly composed of catheters and handles, including batteries. It is used for patients with symptomatic, calcified, and severe degenerative aortic stenosis after being evaluated by the heart team combined with the scoring system and are not suitable for routine surgery to replace the valve, and patients who are older than or equal to 70 years old.

The delivery system of the product can realize the re-recovery, positioning and release of the valve when the valve is not completely released in the body. The design of the circumferential spiral loop stiffener and the hollow groove make the delivery system have the ability to bend in multiple directions and improve its ability in the blood vessel, thereby reducing the risk of vascular complications.”

Source: https://chinameddevice.com/innovation-approval-for-three-medical-devices/