Practical notes on medical device registration, localization, and audit support.
March medical device review data shows synchronized progress across registration review, acceptance, supplementary materials, expert consultation, quality system verification, innovation review, and priority approval.
The 2026 national medical device sampling inspection plan further clarifies inspection requirements, re-inspection procedures, nonconforming product handling, and enterprise responsibilities.
The guideline clarifies requirements for medical device Periodic Safety Update Reports, covering vigilance data, product exposure, risk analysis, conclusions, and attachments.
A March 2026 summary table lists medical device registration review termination notices and related product information.
The trial guideline clarifies core requirements for medical device vigilance plans, covering risk management, data collection, risk analysis, risk control, reporting, and plan review.
A total of 15 medical devices entered the innovative medical device special review application results summary in April.
Ten products are proposed to enter China's innovative medical device channel, covering AI-assisted diagnosis, surgical robotics, 3D-printed implants, and deep brain electrodes.
The new plan gives industry stakeholders an early view of upcoming review guideline priorities for Class II and Class III medical devices.
A flight inspection highlights quality system gaps, weak entrusted manufacturing control, and unreliable production records in medical device manufacturing.
Reposted article: CMDE released draft review guidelines for three medical device categories, further clarifying scope and review focus areas.