NMPA Announcement: Suspension of Import, Distribution, and Use of Three Avinger, Inc. Products

On August 25, 2026, China's National Medical Products Administration issued Announcement No. 80 of 2026, ordering the suspension of import, distribution, and use of three medical device products manufactured by Avinger, Inc.

Products affected:

l Pantheris Catheter (Registration No.: National Medical Device Registration (Import)20263010082)

l Pantheris SV Catheter (Registration No.: National Medical Device Registration (Import)20253010610)

l Lightbox 3 OCT Imaging Console (Registration No.: 国National Medical Device Registration (Import)20263010131)

According to the announcement, NMPA planned to conduct overseas on-site inspections of these products as part of its 2026 overseas inspection program. However, Avinger, Inc. failed to submit the required authorization letters, product information forms, and site master files within the prescribed timeframe.

Pursuant to Article 28 of the Regulations on Overseas Inspection of Drugs and Medical Devices, this constitutes a violation of China's Medical Device Quality Management Practices. To ensure the safety of medical device users, and in accordance with the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Production, NMPA has decided to suspend the import, distribution, and use of the above three products effective immediately.