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.
The Taimenjogen program, launched in late November 2014 concurrent with the
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.