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Pre-Submission Consultation (PMDA Meetings)

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PMDA operates a structured, fee-based pre-submission consultation system that allows applicants to meet with PMDA reviewers before and during the development and application process. Early PMDA engagement is strongly recommended β€” and for novel or complex devices, effectively essential β€” to align on data expectations before committing to costly studies.

Types of PMDA consultation​

RS Strategy Consultation (RS戦η•₯相談) The most important consultation type for innovative or complex devices. Allows discussion of:

  • Overall regulatory strategy (classification, pathway choice)
  • Non-clinical and clinical study design
  • Technical documentation requirements
  • Application timeline planning

RS Strategy Consultations require a fee and are scheduled in advance. They typically involve a face-to-face or video meeting with PMDA reviewers.

Pre-application consultation (申請前相談) Focused consultation closer to submission, covering:

  • Specific data gaps or borderline evidence issues
  • Labelling draft review
  • Manufacturing/QMS issues to resolve before submission

Electronic consultation For less complex questions, PMDA offers a written consultation service where questions are submitted in writing and PMDA responds in writing. Less interactive but faster to arrange.

How to request a consultation​

  1. Prepare a consultation briefing document in Japanese describing the device, the regulatory question, and the current status of development
  2. Submit the consultation request through PMDA's consultation booking system
  3. PMDA confirms the appointment and sends the agenda template
  4. Submit the briefing document to PMDA at least 2–4 weeks before the meeting
  5. Attend the meeting; PMDA provides a written meeting record (θ­°δΊ‹ιŒ²)

What to prepare for a PMDA meeting​

A productive consultation requires:

  • Clear device description with draft intended use statement
  • Proposed JMDN code (even if not finalised)
  • Summary of non-clinical work completed or planned
  • Specific questions for PMDA β€” numbered, concise, and answerable
  • Summary of how you intend to address each question (to enable PMDA to respond substantively)

PMDA meeting records​

PMDA provides written minutes of consultations. These are important documents β€” they represent PMDA's formal position at the time of the meeting and can be referenced in the later application. Note that PMDA's position can change if new guidance is issued or if the device/data changes significantly.