As of January 2026, the administrative system has undergone a terminology refresh to align with international standards. The previous “Medical Device Control Office” has been renamed the Medical Device Division (MDD), and the overarching system now refers to “Medical Devices” rather than “Instruments”.

This update (Version GN-00:2025-3(C)) primarily focuses on clarifying definitions that have become ambiguous with the rise of new manufacturing technologies like 3D printing and AI-driven design.

1. Major Shift: Personalized Medical Devices

The most impactful change for R&D teams is the granular breakdown of “Personalized Medical Devices.” The guidance now strictly separates truly unique items from batch-produced, patient-specific ones.

• Custom-Made Device: A device intended for one specific individual based on a written request from a medical professional, who takes responsibility for the design characteristics.

Constraint: It is for cases where mass-produced alternatives are insufficient.

• Patient-Matched Device: A device matched to a patient’s anatomy (e.g., using medical imaging) but produced using a specified design range and a validatable, reproducible process (mass production).

Key Difference: Unlike custom-made devices, these are designed and produced under the manufacturer’s responsibility.

• Adaptable Medical Device: A mass-produced device intended to be adjusted, assembled, or shaped at the point of care (e.g., by a clinician) to fit a specific patient.

2. Updated Safety Reporting Standards

The guidance replaces “Reportable Medical Incident” with “Reportable Medical Event” and clarifies the threshold for reporting.

What constitutes a “Serious Injury”? The definition has been expanded and now explicitly includes:

1. Life-threatening illness or injury.
   
   
2. Permanent impairment of a body function or structure.
   
   
3. Preventative Intervention: A condition requiring medical/surgical intervention to prevent permanent impairment.

The “Near Miss” Rule Under section 2.47.3, manufacturers must report an event even if no one was dead or seriously injured this time, provided that a recurrence of the same event could lead to death or serious injury.

3. Operational Clarity: “Use Error” vs. “Abnormal Use”

To assist in root-cause analysis, the guidance distinguishes two types of user-related issues:

• Use Error: A slip, lapse, or mistake where the result was not intended by the manufacturer or the user (e.g., misinterpreting an icon).
  
  
• Abnormal Use: An act or omission that is intentional and beyond the manufacturer’s reasonable risk control (e.g., deliberately ignoring a warning label to replace a filter).