Insight into Requirements of PMDA for Marketing Medical Products in Japan

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

Event Details

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
Note: Use Promo code PTY2D and get 10% off on registration (Valid till MARCH 31st 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont 94536

Starts March 31, 2017 at 10:00AM - 1:00PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896