Purpose: To facilitate the rapid introduction of unapproved medical devices that address high medical needs in Japan.

Designation Process: Submission of a request form (by academia/patient groups) → Deliberation by the Needs-based Working Group (WG) → Official designation by the parent committee → "Request for Development" by the MHLW to companies.

Regulatory Benefit: Designated devices qualify for Priority Review, which targets a reduction in the standard review timeline from 12 months to 9 months.

Purpose: To optimize the balance between pre-market and post-market data collection for devices that undergo frequent iterations, where conducting full clinical trials for every change is difficult.

PMDA Pre-submission Consultation: The feasibility of utilizing this framework is determined through PMDA's pre-sub consultations, specifically utilizing Pre-development Consultation (KaihatsumaeSoudan) and Clinical trial Necessity Consultation (RinshoshikeYouhiSoudan).

Example of Rebalancing: Includes the "Two-stage Approval" approach. For example, initial approval may be granted for a limited intended use based on calculated parameters, which is later expanded based on the clinical significance validated through post-market data.

Purpose: To prioritize the review of innovative products developed first in the world and initially applied for in Japan.

Designation Process: Initial consultation with the MHLW (Initial Consultation) → (PMDA Pre-development Consultation) → Submission of Sakigake designation application → Official designation (decided through Bukai deliberation). All four (4) designation criteria must be met.

Regulatory Benefit: Provides intensive support including prioritized PMDA consultations, Priority Reviews, and the assignment of a PMDA Concierge to guide the development process.

Purpose: To promote the R&D of devices where medical needs are significantly unmet, such as those lacking pediatric dosage or usage settings.

Designation Process: Submission of a request to the MHLW → PMDA Pre-development Consultation and evaluation by the Needs-based WG → Official designation via Council deliberation.

Regulatory Benefit: Access to prioritized consultations and Priority Reviews to enhance pre-evaluation for early approval.

Purpose: To grant early approval for devices intended for rare diseases where completing standard clinical trials would take an excessively long time due to small patient populations.

Designation Process: PMDA Pre-development Consultation (Confirming eligibility) → Clinical Trial Necessity Consultation (including the evaluation of the Risk Management Plan: RMP).

Post-market Requirements: Approval is linked to a Risk Management Plan (RMP), requiring a "Use Results Evaluation" (post-market surveillance) after the product is on the market.

Regulatory Benefit: Waiver of clinical trial requirements if specific criteria of Type 1 & 2 are met.

Purpose: A system that approves the "Improvement/Change Plan" itself for devices expected to undergo frequent post-market modifications.

Designation Process: PMDA Pre-development Consultation (functioning as a consultation on eligibility for the time being) → Submission of Application or Notification for the change plan → Post-market updates via Minor Change Notification in accordance with the pre-confirmed plan.

Regulatory Benefit: If changes are made according to the pre-confirmed plan and achieve the expected results, a full Partial Change Application (Ichihen) is not required for each update.

This is particularly applicable to Software as a Medical Device (SaMD).