BEIJING—The National Medical Products Administration (NMPA) of China has issued a notification to immediately suspend the import, operation, and use of Nd:YAG laser surgery equipment manufactured by South Korea-based Jeisys Medical Inc. The decision comes in the wake of a remote non-site inspection, which revealed critical deficiencies in the company’s quality management system, particularly in production traceability and product inspection .
The NMPA’s action is a response to potential safety hazards associated with the equipment. It reflects the regulator’s commitment to ensuring the quality, safety, and efficacy of medical devices in accordance with the ‘Regulations on Supervision and Administration of Medical Devices’ and the ‘Provisions for Supervision and Administration of Medical Device Manufacturing’ .
The Jeisys Medical Inc.’s product in question, with the registration number ‘National Medical Device Registration 20143015997’, has been found to be lacking in effective corrective and preventive measures for non-conforming items identified during sampling. This suspension is a precautionary step to safeguard public health and maintain the integrity of the medical device market in China .- Flcube.com
