China Strengthens Medical Device Quality with 2024 Spot Check Inspection Initiative
China's National Medical Products Administration (NMPA) has taken a decisive step to enhance the safety and quality of medical devices across the nation. The NMPA has issued a directive to drug regulatory authorities at all levels.
The 2024 spot check targets a wide array of medical devices (66 products) including high-frequency electrosurgical units, surgical electrodes (for high-frequency monopolar use), breast implants, assisted reproductive egg retrieval needles, powder/liquid acid-base cement, electrocardiogram machines, medical pulse oximeters, medical protective masks, limb compression therapy devices, intracranial coils, dental cone beam computed tomography equipment, medical molecular sieve oxygen generators, injection pumps, otoacoustic emission devices, carbon dioxide laser therapy machines, arthroscopes, intense pulsed light therapy devices, soft contact lenses, corneal reshaping hard gas-permeable contact lenses, titanium and titanium alloy dental implants, ultrasonic soft tissue surgical devices, ophthalmic ultrasound diagnostic equipment, and hip joint prostheses - femoral stems, among others.
Inspection agencies are urged to meticulously collect data on instances where the complete range of applicable inspection items could not be conducted as per the inspection plan. Situations where the product registrant, record holder, or the import product agent fails to provide all necessary documentation and accessories required for the inspection, or where product technical requirements are incomplete, thereby hindering the completion of inspections, are to be formally reported. Provincial drug regulatory departments are tasked with investigating and addressing these issues promptly. They are also instructed to document investigation findings in the enterprise credit files and intensify supervision and inspection measures for the companies and products concerned.
Upon receiving a non-compliance report, medical device registrants, record holders, and sampled units are expected to immediately implement risk control measures. Drug regulatory departments are required to organize timely investigations and, where applicable, initiate legal proceedings; cases suspected of criminal activity are to be transferred to judicial authorities.
This initiative underscores China's commitment to ensuring the highest standards of medical device safety and efficacy, safeguarding public health, and maintaining regulatory compliance within the medical device sector.
Currently, some of TX Medical clients have received the unannounced inspection on quality management system as well. If any inquiries or further assistance, please reach out to contact@txcro.com.