October 2026 — The global medical device industry is seeing a wave of regulatory and market updates this month.
1. China's 7th National Consumables Procurement Launches
The national high-value consumables procurement office has officially issued the procurement documents for the 7th batch, focusing on gastrointestinal intervention consumables — covering 23 categories of single-use products such as polypectomy snares, stone extraction and hemostasis devices. More than 200 enterprises are expected to compete. The rules continue to shift toward clinical value, stable supply and optimized pricing.
2. New Medical Device GMP Enters Final Countdown
China's revised Good Manufacturing Practice for Medical Devices* takes effect on 1 November 2026 — the first major revision since 2014, with 15 chapters and 132 articles. Local regulators nationwide are holding training sessions and enterprise briefings to help manufacturers align their quality systems before implementation.
3. FDA Classifies Pulse Oximetry Monitoring Adjunct as Class II
The U.S. FDA has finalized a rule classifying the hyperoxia monitoring device adjunct to pulse oximetry into Class II with special controls, providing a clear regulatory pathway and reasonable assurance of safety and effectiveness for next-generation oxygen monitoring products. This is directly relevant to fingertip pulse oximeter manufacturers and exporters.
4. High-End Medical Equipment Innovation Continues
China's MIIT, NHC and NMPA have opened applications for the 2026 High-End Medical Equipment Promotion Program, supporting the large-scale deployment of imaging systems, surgical robots and other advanced devices.
Outlook: With tighter GMP enforcement, expanded centralized procurement and clearer global regulatory pathways, manufacturers are expected to focus on quality systems, innovation and international compliance.