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Insight into Requirements of PMDA for Marketing Medical Products in Japan

Friday, Mar 31, 2017 at 10:00AM - 1:00PM

Online Event

  • Mar 2017

    31 Fri

    10:00AM

  • Mar 2017

    31 Fri

    1:00PM

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Insight into Requirements of PMDA for Marketing Medical Products in Japan

Friday, Mar 31, 2017 at 10:00AM - 1:00PM

Fremont

No tickets available

Description
In this important presentation you will gain a thorough understanding of how to make a market entry and sustain your medical device in the second largest medical device market that is worth over 35 billion Euros per year. Gaining this insight will help you to overcome the challenges associated with the fact that regulatory clearance in Japan is through PMDA (Pharmaceutical and Medical Device Agency), which is considered as one of the most difficult in the world.

The Japanese regulatory process, device classification scheme, accreditation of foreign manufacturers, in-country representation and conformance requirements to MHLW Ordinance 169 will be discussed along with tips on the possibility of simplifying your Japanese entry through certification bodies in Europe.

Objectives of the Presentation
Key Learning Objectives of this important topic are:
  • Understanding Japan's Medical Device System
  • Its Regulatory Outlook: Overview of the regulatory process
  • Why Japan despite the challenges posed by this market?
  • Japan's device classification model
  • Accreditation by foreign manufacturers
  • Compliance to MHLW Ordinance 169 and its correlation to other standards and regulations
  • In country representation and maintenance of the ongoing market share
  • Time and cost associated with this key entry for your company
Why Should you Attend
Japan imports over 35% of its medical devices from abroad and this has been growing due to the steadily increasing aging population in Japan. The market is competitive, demands a high quality product and to add to this, is the tough regulatory process of PMDA within the Japanese Ministry of Health, Labor and welfare, (MHLW). You should attend this webinar so you can get an insight into how you can fulfill the PMDA requirements and legally sell your medical device in Japan by understanding their classification scheme, product codes and challenges associated with breaking through this financially enticing medical device market.

Areas Covered
  • A brief overview of the importance of the Japanese Market
  • Why make an entry into this key market for your medical devices?
  • Introduction to its healthcare system and regulatory requirements
  • Determining the regulatory process for your device and the classification scheme
  • The heavy responsibilities of the Marketing Authorization Holder(MAH)
  • Basic compliance requirements of MHLW Ordinance #169
  • Submission pathway and completion to obtain the PMDA Certification to distribute your device in Japan
Who will Benefit
Representatives from growing medical device companies interested in expanding their geography into Japan. Specifically,
  • Regulatory Managers and Associates
  • Business Managers
  • Quality professionals who want to know about PMDA requirements for medical devices
  • Business Analysts
  • Small and large fast growing medical device manufacturers
  • Strategic planners in the medical device industry at all levels
For Registration
http://onlinecompliancepanel.com/webinar/PMDA-MARKETING-MEDICAL-PRODUCTS-505236/MARCH-2017-ES-EZEVENT
Note: Use Promo code PTY2D and get 10% off on registration (Valid till MARCH 31st 2017)

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