Japan’s PMDA Now Offers Pre-Consultations for Medical Device Registrants

In conjunction with the recent implementation of the Pharmaceutical and Medical Device Act (PMD Act), Japanese regulators have launched a new pre-consultation program to assist registrants as they begin their device certification application processes.

PMDA pre-consultation for medical device certification and approval in JapanThe Taimenjogen program, launched in late November 2014 concurrent with the PMD Act’s implementation, includes six different pre-certification PMDA consultation options at various price points, and is intended to further clarify Japanese registration requirements for manufacturers.

The PMDA’s pre-consultation options include:

  • General Introduction Consultation (Zenpan Sodan): introduces relevant MHLW guidance notifications and regulations to applicant and suggests which further pre-consultation pathways for applicant to take
  • Pre-Meeting for Pre-Consultation (Taimen Jogen Junbi Mendan): PMDA confirms and organizes materials and issues to be discussed during formal Pre-Consultation
  • Pre-Development Consultation (Kaihatsumae Sodan): Consulting on applicant’s expected data package framework, including any required device testing and clinical investigation
  • Clinical Trial Necessity Consultation (Rinsho Yohi Sodan): Determining whether additional clinical trials based on existing clinical or non-clinical data will be necessary
  • Protocol Consultation (Protocol Sodan): Consultations on specifications for safety, quality, performance testing, pilot studies and clinical trial protocol validity
  • Simple Consultation (Kani Sodan): Consultation to determine applicant’s appropriate submission route, and whether applicant can register an entire product family through a single registration application

Although not as straightforward as the US Food and Drug Administration’s Pre-Submission consultation system for registrants, the PMDA’s pre-consultation program nonetheless allows manufacturers unfamiliar with Japanese pre-market certification and approval requirements to get a better idea of the steps necessary for obtaining market authorization.

 

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