MMD-120    Understanding MHLW Ministerial Ordinance No. 169 (Japan) - Quality
​                      Management System for Medical Devices

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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Japan's PMD Act ("Act on Securing Quality Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics") was issued by the Ministry of Health, Labour, and Welfare (MHLW) in 2014. Among other things, it defines quality management system (QMS) requirements for medical device manufacturers selling their devices in Japan. It also introduced specific requirements for domestic and foreign manufacturers and harmonized QMS requirements with ISO 13485:2016.
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By the end of this course, participants will be able to:

• Gain a clear overview of the MHLW Ministerial Ordinance No. 169 (MO 169) and its role in Japan’s medical device regulatory framework.
• Develop a working knowledge of the requirements under MO 169 and understand how these requirements are applied within a Quality Management System.
• Understand the key expectations of Japanese regulatory authorities during regulatory inspections and audits.
• Prepare effectively to host and support regulatory audits in accordance with MO 169 requirements.

• Module 1: Introduction to MHLW MO 169 and Japan Regulatory Framework
• Module 2: Key Requirements of MHLW MO 169
  
• Module 3: Application and Implementation of MO 169 Requirements
  
• Module 4: Regulatory Audits, Case Study and Discussion
  

This course is designed for anyone who may involve in the implementation and execution of this Quality System Regulation.

This is a 1 day programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.