1. China Optimizes Approval Process for High-End Medical Devices
The National Medical Products Administration (NMPA) passed the Measures on Optimizing Full Lifecycle Regulation to Support Innovation in High-End Medical Devices on June 20, introducing 10 key initiatives, including:

• Special Innovation Review Procedure: For domestically pioneered and globally leading products (e.g., surgical robots, AI medical devices), evaluation is advanced to the R&D phase. An exploratory "conditional approval" mechanism aims to shorten time-to-market.

• Standardization System Development: Accelerated formulation of standards for novel materials (e.g., medical exoskeletons, brain-computer interface flexible electrodes) and establishment of an AI Medical Device Standardization Committee.

• Goal: Accelerate commercialization of R&D achievements and boost overseas expansion of domestic high-end devices (projected market size: $312B by the 15th Five-Year Plan period, capturing 28% of global share).

2. Global Regulatory Dynamics

• FDA:

• Upgraded cardiac radiofrequency ablation catheters to Class III devices, requiring PMTA submissions.

• Streamlined 510(k) pathways for Class II devices (e.g., glucose meters, blood pressure monitors).

• EU:

• Mandated cybersecurity compliance for wearables (effective 2026).

• Extended IVDR transition period to 2027.

• Japan/Saudi Arabia:

• Required reporting of severe adverse events within 24 hours.

• Enforced 40% localization rate for foreign manufacturers.