Insight into Requirements of PMDA for Marketing Medical Products in Japan 2017

Topics

• Why make an entry into this key market for your medical devices?
• A brief overview of the importance of the Japanese Market
• Determining the regulatory process for your device and the classification scheme
• Introduction to its healthcare system and regulatory requirements
• Basic compliance requirements of MHLW Ordinance #169
• The heavy responsibilities of the Marketing Authorization Holder(MAH)
• Submission pathway and completion to obtain the PMDA Certification to distribute your device in Japan

Who should Attend

Attendees from medical device companies:

• Business Managers
• Regulatory Managers and Associates
• Business Analysts
• Quality professionals who want to know about PMDA requirements for medical devices
• Strategic planners in the medical device industry at all levels
• Small and large fast growing medical device manufacturers