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News

Japanese medical regulations webcast

Research And Markets : 15 January, 2014  (New Product)
Low cost Webcast available explaining regulations in the medical device market in Japan
Japanese medical regulations webcast


Research and Markets has announced the addition of the "2014 Japan Medical Device Regulatory Updates" audio conference to their offering.



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.



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.



The low-cost webcast can be purchased directly from the Research and Markets website for 244 pounds here: "2014 Japan Medical Device Regulatory Updates"



 


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