Innovation in Medical Devices Proceeds Hand in Hand with Industry Regulation!
On February 9, the National Medical Products Administration (NMPA) announced the approval of a new innovative medical device for marketing while also releasing the January 2026 filing information for imported Class I medical devices, injecting new vitality into industry development.
/01/
Transcatheter Aortic Valve System Approved for Marketing
On February 9, the 399th innovative medical device approved by the National Medical Products Administration (NMPA) was granted market approval ——Transcatheter Aortic Valve System.
Product Information Overview:
◆ Manufacturer: Kokai (Nantong) Life Sciences Co., Ltd.
◆ Registration Certificate No.: China Medical Device Registration Approval 20263130289
The product is composed of an aortic valve, delivery system, and loading device. The valve leaflets are made of bovine pericardial material, and the surface of the delivery system is coated with a hydrophilic coating.
Applicable to patients aged 70 years and above with symptomatic severe aortic regurgitation, and such patients are not suitable for conventional surgical valve replacement (requires assessment by a cardiac team in conjunction with a scoring system).
The drug supervision and administration department has made it clear that it will strengthen the post-marketing supervision of this medical device to ensure the safety of patients using the device.
/02/
January 2026 Import of Class I Medical Device Product Filing Information
On the same day, the filing information for Class I medical device products imported in January this year was officially announced, involving a total of 73 products covering multiple clinical subfields.
The filing status is mainly "valid" and "changed," with only a few products marked as "invalid." Overall compliance is good.
◆47 Changes:
◆21 Effective:
◆5 Ineffective
OFweekMedical Device TechnologyWill continue to track industry regulatory developments and technological innovation achievements, providing practitioners with timely and authoritative information references.
"Information Source"
Transcatheter Aortic Valve System Approved for Marketing:
https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20260209165846183.html
Product Filing Information for Imported Class I Medical Devices in January 2026:
https://www.nmpa.gov.cn/ylqx/ylqxjgdt/20260209141522187.html
