MEDTECH NEWS

On April 8, 2026, China's NMPA officially launched its 2026 National Medical Device Quality Sampling Inspection Program, covering 74 device categories spanning implantables, diagnostics, therapeutic equipment, and surgical consumables. Provincial and national testing institutions are mandated to conduct inspections against mandatory standards and approved product technical specifications, with non-compliant manufacturers required to immediately implement risk control measures — and cases involving potential criminal liability referred to judicial authorities. The program reflects China's continued commitment to strengthening medical device quality oversight and advancing patient safety across a broad spectrum of high-risk and high-value device categories.

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.

In a recent announcement, China's National Medical Products Administration (NMPA) revealed the results of its latest medical device quality inspection, examining 17 categories of products. Out of these, 24 batches failed to meet the required standards. Key issues were found in high-frequency electrosurgical units from Gebrüder Martin GmbH & Co.KG and a Chinese company, intense pulsed light therapy devices from ActiveOptical Systems Ltd., pulse oximeters from various Chinese manufacturers, and other products such as scar repair gel, arthroscopes by ConMed Corporation, soft contact lenses, hydrocolloid dressings from Paul Hartmann AG, and medical protective masks and clothing. The NMPA has directed local authorities to enforce administrative actions, requiring companies to conduct risk assessments, recall products if necessary, and implement corrective measures. This inspection underscores China's dedication to maintaining high standards of quality and safety for medical devices in the market, impacting both domestic and international companies.

The National Medical Products Administration (NMPA) has released the results of its national supervision and sampling inspection of medical devices, revealing that seven batches of products, including semiconductor laser therapy machines, medical pulse oximeters, and orthodontic wires, failed to meet required standards. The non-compliant items were found to have issues with input power, data integrity, and physical dimensions among others. The NMPA has mandated provincial regulatory authorities to enforce corrective measures, conduct risk assessments, and ensure public disclosure of product recalls.

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.

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.

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.

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.

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.

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.