China NMPA suspends several foreign medical device manufacturers

China's National Medical Products Administration (NMPA) has implemented several import and distribution suspensions for prominent foreign medical device manufacturers following inspections. These enforcement actions stem from failures to meet the current 2014 Medical Device Production Quality Management Standard.

Notable companies affected by these suspensions include Germany’s Karl Storz and Eurocor GmbH, Japan’s Hoya Technosurgical, the United States’ Avinger Inc., and Denmark’s Coloplast. Other impacted entities include the UK’s Laurus Optics Limited. The suspensions cover various products, including high-frequency surgical equipment, surgical implants, and foam dressings.

These regulatory actions occur as China transitions to a revised Good Manufacturing Practice (GMP) framework. While current suspensions are based on the 2014 regulations, the new GMP, which takes full effect on November 1, 2026, will introduce more prescriptive requirements regarding documentation, design control, and quality assurance.