Faster Route to Japanese Market with New Standards

Can Ninsho get me to market faster?

In Japan a new PAL (regulatory affairs law) was implemented and some submission categories were established. Ninsho is one of these submission categories. It is applied for me-too medical devices and offers a faster route to market.

 

Applying Ninsho to your device

From this e-Conference you will get a clear image of the faster route of submission in Japan, and it will help you determine submission strategies for me-too devices. We will cover:
-- Submission categories of medical devices in Japan
-- What kinds of medical devices can be applied to the faster route
-- Details of the submission requirements  (Definitions, technical requirements, required documents, etc.)
-- Procedural flow from submission to approval
-- Current problems and trends of this category.

We will present:
-- Examples to explain what's required.
-- Facts and data to explain what kinds of medical devices can be applied for this category.
-- A flow chart to explain procedural flow.
-- Current problems and suggestions to solve the problems.
-- A check list of essential requirements
-- A list of RCBs

You will receive:
[x] PowerPoint slides
[x] An expert speaker
[x] CEUs and certificate of attendance

Audience suitability:
[x] Medical device professionals who work with Japanese clinical trials.
[x] Marketing managers who plan to sell devices in Japan.
[x] Executives who are planning their companies futures.

Presenter:
Nobuko Matsunaga is Chief Regulatory Officer at Japan Medical Device Consulting. In addition to the daily work of regulatory consulting, she also contributes to improving the regulatory environment in Japan as a member of the regulatory sub-committee of the European Business Council of Japan. You can reach Ms. Matsunaga at nobuko.m@j-mdc.com or www.j-mdc.com.

The purchase is $420 for OnDemand access and $470 for the CD. Event materials are available by download for OnDemand or are on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.