Announcement on the Suspension of Production by Three Medical Device Manufacturers in Jiangsu Province (No. 12, 2024) by the Jiangsu Provincial Drug Administration

Recently, the Jiangsu Provincial Medical Products Administration discovered during the organization of supervisory inspections of medical device manufacturing enterprises thatChangzhou Nanxiang Medical Apparatus Co.,Ltd.(Su Medical Device Manufacturing Permit No. 20010691),XinRong Medical Group(Su Food and Drug Administration Medical Device Production License No. 20010410),Awakzon Medical (Jiangsu) Co., LTD(Su Medical Device Manufacturing Permit No. 20220172)Three companies have serious defects in their quality management systems, failing to comply with the relevant regulations of the "Good Manufacturing Practice for Medical Devices."The Jiangsu Provincial Drug Administration has acted in accordance with the provisions of Article 2, Paragraph 64 of the Measures for the Supervision and Administration of Medical Device Production and Article 25 of the Measures for Unannounced Inspections of Drugs and Medical Devices.Three companies have been ordered to halt production as a risk control measure.

Hereby announced.

Jiangsu Provincial Drug Administration

July 1, 2024