NMPA Announces Results of National Medical Device Supervision and Inspection (Announcement No. 42 of 2024)
The National Medical Products Administration conducted a national inspection on 7 categories of medical devices, finding 11 batches/units that did not meet quality standards, including issues with ultrasound therapy equipment, high-frequency electrosurgical units, nebulizers, limb compression therapy equipment, dental cements, and dental products. The administration has ordered provincial authorities to take enforcement actions, require the manufacturers to assess risks, recall the non-compliant products, investigate the causes, and implement corrective measures.
China's NMPA Announces Results of Medical Device Quality Inspection (Notice No. 35 of 2024)
The National Medical Products Administration (NMPA) of China has released the results of its latest quality inspection of medical devices. The inspection, covering 17 categories of products, found 24 batches (units) that failed to meet the required standards on September 12, 2024.
Read MoreChina's NMPA Reports Five Cases of Illegal Medical Device Sales Online (Batch Six)
On May 31, 2024, the National Medical Products Administration (NMPA) released information about five recent cases of illegal online sales of medical devices. The NMPA has taken stern actions to regulate the online sale of medical devices to protect public health and ensure device safety.
Read MoreRecent Enforcement Actions in China’s Medical Device Sector Highlight Regulatory Compliance
The National Medical Products Administration of China has unveiled six significant cases of regulatory violations within the medical device sector, emphasizing its dedication to enforcing stringent safety and legality standards. These instances involve various infractions, including the production and distribution of unregistered and expired medical devices, discrepancies in manufacturer information, and submission of falsified documents. Notable cases include Shanghai Youya Pharmaceutical Technology Co., Ltd., which faced hefty fines and confiscation of illegal gains for unauthorized production, and Chongqing Hexi Medical Beauty Clinic, which incurred a major penalty for using non-compliant Class III medical devices. These actions reflect China's proactive approach to ensuring compliance in the medical device industry, aiming to safeguard public health through rigorous regulatory oversight.
Read MoreChina's NMPA Reports on the Fifth Batch of Illegal Online Sales of Medical Devices
China's NMPA has escalated its efforts against illegal online sales of medical devices, announcing the fifth batch of enforcement actions on March 27, 2024. This initiative focuses on enhancing online sales supervision and utilizing a national monitoring platform to identify and address illegal activities. Recent investigations have led to penalties for unauthorized sales and sales of unregistered medical devices on various platforms, emphasizing the need for compliance with medical device regulations. The NMPA's strict measures aim to ensure the safety and legality of medical device usage, reinforcing public health protections by penalizing non-compliant practices in the industry.
Read MoreChina Strengthens Medical Device Quality with 2024 Spot Check Inspection Initiative
China's National Medical Products Administration (NMPA) has launched the 2024 Medical Device Spot Check Plan, targeting a wide array of devices for quality and safety inspections, mandating provincial drug regulatory authorities and relevant authorities to conduct thorough inspections, address non-compliance with immediate risk control measures and legal actions, and ensure the medical device sector meets the highest safety and efficacy standards, underscoring the country's commitment to public health and regulatory compliance.
Read MoreNew Measures to Support the Development of the Modern Life Sciences and Biotechnology Industry in Xiong'an New Area
Xiong'an New Area introduces comprehensive measures to support the life sciences and biotechnology sectors, including financial incentives for the industrialization of medical devices, support for international registration and certification of drugs and devices, subsidies for public service platform establishment, encouragement of special medical food industry development, and promotion of pharmaceutical clinical application and research, aiming to foster innovation and position the area as a leading hub in these fields.
Read MoreChina Enhances Medical Device Registration and Supervision in 2023
In 2023, China significantly advanced its medical device regulatory framework, innovation approval rates, and international standardization efforts, while also enhancing clinical trial, registration, and standard quality management.
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