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Schedule:
May 20, 2009 at 11:00 am Central
Fee: $420 per computer
connection
Agenda:
Lecture - 60 minutes
Q&A - 30 minutes
How it
works:
Once your order is
processed, you will receive an email with a receipt for the credit card
transaction from our office. You will also receive an automatically generated
email with an invitation for you to register in the course. Please register, provide your
email address and create a password. Once your invitation is accepted, you
will receive an automatically generated email with the link to join the session. |
Changes in Japanese Shonin Regulations
Japanese Reforms for Device Approval (Shonin)
Your company is bound to want to sell its devices in Japan eventually. The
figure below, even though for drugs, shows Japan to be the second largest
healthcare market in the world. With an aging population, it is one of the
most desirable markets for medical devices.

http://www.morganlewis.com/pubs/Overview_Pharma_device_reg.pdf
But for foreign manufacturers, complying with Japan's
Pharmaceutical Affairs Law (PAL) can be challenging. Few English language
documents have been issued by the Ministry of Health, Labor and Welfare (MHLW)
and its division, the Pharmaceutical and Medical Devices Agency (PMDA).
Language barriers and a complex registration process make Japan one of the
most difficult and time consuming markets for medical device manufacturers
to enter.
Concerned that Japan’s reputation as a difficult market
might cause it to fall behind, the Japanese government made significant
revisions to PAL in 2005, but many people feel the changes have not been
enough. Shonin regulations, which control the process of approval to market
medical devices in Japan, have also been recently reformed.
Depending on the level of novelty, medical devices shall be
classified into three levels: new medical devices, improved medical devices,
and "me-too" medical devices (devices with a predicate technology already on
the market), with each evaluated by a specialized team. The new evaluation
system will simplify the application forms (including partial changes) and
may
shorten the evaluation process for minor modifications, such as changing
a raw material in a device that does not affect the function or efficacy of
the device.
Once part of a previous review process in Japan, the
three-track evaluation system was discontinued when the new regulatory rules
were implemented in 2005. Taking into account current criticism, MHLW/ PMDA
decided to revive the previous review method, which will be rolled out in a
step-by-step fashion beginning in April.
Learning
Objective
In this e-conference you will learn about the new submission categories,
overviews of each Shonin category, and the role of clinical trial data for
each of them.
Making a New
Submission Strategy
Two questions:
As a manufacturer of a Class II medical device with two facilities (a
headquarters and a manufacturing plant) what has to be done, and what is the
best way to enter the Japanese market?
[1] Register the manufacturing facility (Nintei)?
[2] Nominate a Market Authorization Holder (MAH) or A-MAH (Appointed MAH) in
Japan?
[2] Obtain Shonin (device approval) or Certification (device certification)?
As a manufacturer of a Class III medical device, what
is your best strategy for entering the Japanese market?
[1] Nominate a MAH or A-MAH in Japan who has a license to market your
product?
[2] Register the manufacturing facility(Nintei)?
[3] Obtain Shonin pre-market approval?
[4] Determine who can sell the devices in the Japanese market?
In this e-conference we’ll discuss how you decide which
strategy is right for you.
Because of the time difference between Chicago and Tokyo,
this e-conference will be pre-recorded. The audio will be broadcast by VoIP
on your computer speakers.
You will have a chance to submit questions during the
broadcast, which will be answered in writing by Ms. Matsunaga. When you
register you may submit questions before the e-conference if you like.
You will
receive
[x] Spreadsheet of application categories and requirements.
[x] Glossary of Japanese regulatory terms.
[x] PowerPoint slides
[x] An expert speaker
[x] Chance for QnA
[x] CEUs and certificate of attendance.
Who should
attend
[x] Regulatory professionals who are involved in Japanese
submissions.
[x] Clinical research professionals who design clinical trials for Japan.
[x] Device manufacturers planning to export to Japan.
[x] Marketing professionals who plan to market in Japan.
[x] Executives who are planning the future of their company.
Presenter
Nobuko Matsunaga is Chief Regulatory Officer at
Japan Medical Device Consulting. Before
founding Japan MDC with
Kunihiko Mitsuda, Ms. Matsunaga worked in the area of regulatory affairs
in the medical device field. At Japan MDC, she has worked on product
registration for various types of medical devices.
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 EBC (The
European Business Council in Japan).
She can be reached at nobuko.m@j-mdc.com
or www.j-mdc.com. |