China has implemented stricter requirements over medical device manufacturing and quality systems. Analyzing China’s 2024 inspection data for overseas manufacturers reveals three key developments: heightened post-pandemic scrutiny, the growing reliance on remote GMP audits, and enhanced interprovincial collaboration in quality inspections.
1. Stricter Post-Pandemic Oversight
Since COVID-19, China has reinforced its regulatory framework to ensure higher safety and compliance standards. The NMPA has taken decisive actions against overseas manufacturers with significant quality management system (QMS) deficiencies. Companies such as SAMO S.p.A and Jeisys Medical Inc. faced strict penalties, including import bans and market suspensions. For domestic quality inspection, overseas manufacturers were required to recall non-compliant products and implement corrective measures. For example, the Air Pressure Therapy Device was found to have therapeutic pressure inconsistencies, prompting regulatory intervention. These measures underscore China’s commitment to safeguarding product quality in a post-pandemic world.
2. Rise of Remote GMP Audits
Remote GMP audits have become the primary method for assessing overseas manufacturers. Of the six documented GMP inspections, five were conducted remotely—including those for SAMO S.p.A and Search Medical Co., Ltd.—while only one company, SDM Co., Ltd., underwent an onsite audit due to critical QMS concerns. While remote audits offer logistical and cost-saving benefits, they also present challenges in evaluating physical production processes. Meanwhile, domestic manufacturers continued to undergo in-person inspections, reflecting the regulators’ emphasis on hands-on verification for local facilities.
3. Increased Interprovincial Coordination in Quality Inspections
Domestic quality inspections on overseas manufacturers now frequently involve specialized testing units from different provinces, demonstrating a more collaborative regulatory approach. For instance, Beijing’s NMPA worked with Hebei’s testing institute to evaluate the Air Pressure Therapy Device, while Guangdong authorities partnered with Zhejiang’s institute for Diamond Bur inspections. By leveraging regional expertise, this decentralized model enhances technical rigor and resource efficiency, though it may also introduce logistical challenges. Consistently, provincial NMPA branches have relied on specialized institutes to conduct in-depth product evaluations.
China’s regulatory landscape has evolved to emphasize stricter oversight, leveraging remote audits for international manufacturers while enhancing domestic quality control through cross-provincial collaboration. These measures reinforce product safety and regulatory compliance, making China a more reliable market for high-quality manufacturers. As global supply chains continue to adapt, aligning remote audit standards with international best practices and fostering regulatory cooperation will be essential for accessing China medical device market.
For overseas manufacturers inspected (GMP audits and quality inspection), please see below table:
