Japan is the second largest medical device market in the world. Getting through the registration process and selling your product on the market is not an easy task. This webcast will focus on key steps including PMDA consultation sessions, how to maximize foreign clinical data, and how to expedite product registration. This is a very detailed and informative webcast. The presenter is Ames Gross, president of Pacific Bridge Medical. Mr. Gross has been doing business in Japan for 30 years. There will be a 60-minute presentation followed by a 30-minute Q&A session. This presentation includes: PMDA Consultations – What they are, how they work, and how much they cost. Device Classification – How classification is determined and the criteria that must be met for each classification. Product Registration – More third party inspections and the best ways to succeed. FMA – Recent changes. QMS – Recent changes. Overseas Clinical Data – Can it be used for medical device approval and what factors to consider. Japanese GCP – How to ensure your clinical trials meet Japanese GCP requirements. New Device Regulations – Changes regarding raw materials, cellular and gene therapy, and software. Device Reimbursement – Don’t register unless you can get decent reimbursement. Who should attend: This webcast is designed for medical device professionals in regulatory affairs, business development, international sales and marketing, and anyone who wants to be current on Japanese regulatory issues. Presenter: Ames Gross, President and Founder of Pacific Bridge Medical.
Overview The PMDA pre-meeting isa) to obtain explanation from PMDA about the Japanese Pharmaceutical Affairs Law (PAL)b) to discuss which PMDA consultation category is appropriate and what
information/document you have to prepare for the PMDA meeting. This consultation is also to have a follow-up discussion for topics that is not substantive issues such as minor changes after the PMDA clinical trial consultation, etc.
Document to be prepared for the meeting
Document related to the question
Length of meeting a) 10 minutes (Face-to-face or on a phone)b) 30 minutes (Face-to-face or on a phone)
