NMPA Announces Results of National Medical Device Supervision and Inspection (Announcement No. 42 of 2024)
In order to strengthen the supervision and management of medical devices and ensure the quality, safety and effectiveness of medical device products, the National Medical Products Administration organized a product quality supervision and inspection on 7 categories of medical devices, including ultrasound therapy equipment and high-frequency electrosurgical units. 11 batches (units) of products were found not to meet the standard requirements. The specific situation is announced as follows:
I. Medical device products that do not meet the standard requirements in the inspection
(I) 1 unit of ultrasound therapy equipment: produced by Shanxi Xunmei Medical Technology Co., Ltd., involving samples that cannot be used normally during the normal inspection process.
(II) 1 unit of high-frequency electrosurgical unit: produced by Beijing Yingjiehua Technology Co., Ltd., involving the protection of radio business not meeting the standard requirements.
(III) 2 units of medical electric compression nebulizers: 1 produced by Foshan Shunde Good Life Electronic Technology Co., Ltd., involving input power not meeting the standard requirements; 1 produced by Sleada Medical Products (Huizhou) Co., Ltd., involving noise not meeting the standard requirements.
(IV) 1 unit of limb compression therapy equipment: produced by Changsha Longzhjie Technology Co., Ltd., involving pressure relief measures not meeting the standard requirements.
(V) 2 batches of powder/liquid acid-base water-based dental cements: 1 produced by Conamco S.A. de C.V. Beautiful Dentistry, 1 produced by Southern Dental Industries Limited (SDI Limited), involving compressive strength not meeting the standard requirements.
(VI) 3 batches of dental burs: 1 produced by Fuquan Zhuangqian Technology Co., Ltd., 1 produced by Huaxin Medical Devices Co., Ltd. of Huaxian County, 1 produced by Shofu Inc., involving dimensions not meeting the standard requirements.
(VII) 1 batch of orthodontic wires: produced by Dentos Inc., involving dimensions not meeting the standard requirements.
The specific situations of the above-mentioned products that do not meet the standard requirements are attached.
II. Regulatory requirements
For the products found not to meet the standard requirements in the inspection, the National Medical Products Administration has required the provincial drug regulatory authorities where the enterprises are located to make administrative decisions in a timely manner and publicly announce them in accordance with the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, and the Measures for the Administration of Medical Device Recalls. The provincial drug regulatory authorities should urge the enterprises to conduct risk assessments on the products that do not meet the standard requirements, determine the recall level based on the severity of the medical device defects, actively recall the products and publicly release the recall information; urge the enterprises to find out the reasons for the non-compliance of the products as soon as possible, formulate corrective measures and complete the rectification on schedule.
The administration has required provincial drug regulatory authorities to take timely administrative actions, urge the enterprises to conduct risk assessments, recall the non-compliant products, investigate the causes, and implement corrective measures.
Release date: October 25, 2024