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Quality is always the result of excellent work without compromise.​

MMD-112    An Overview of 21 Japanese Pharmaceuticals & Medical Device Laws

  • Overview
  • Course Objectives
  • Course Content
  • For Whom
  • Schedule and Hours
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In Japan, pharmaceuticals and medical devices are controlled by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). The PMDA is an independent agency that works closely with the MHLW to assess the safety and efficiency of medical products. Japan uses a risk-based classification system to categorize medical devices into four classes based on the associated risk (i.e. Class I – lowest potential risk; Class IV – highest potential risk).

In November 2014, the Japanese pharmaceutical and medical device market experienced major changes due to replacement of the Japanese Pharmaceutical Affairs Law (JPAL) with the new Pharmaceutical and Medical Device Act (PMD Act). The PMD Act upsets main areas of medical device regulations, including quality management system compliance, device registration, the regulation of medical software, and third-party certifications.  In order to market medical devices in Japan, manufacturers must be compliant with the current PMD Act.
The program examines the revised medical device legislative framework on medical devices, followed by a detailed explanation on the Quality Management System (J-QMS) requirements placed on foreign manufacturers vide Ministerial Ordinance 169/2004 (amended by Ministerial Ordinance 87, issued on July 30, 2014) launched as of November 25, 2014 and Ordinance 2 under the JPMDL (Japanese Pharmaceutical and Medical Devices Law). 

Participants will gain the knowledge needed to effectively manage changes under the amended J-QMS Ordinance and learn how to apply these changes to achieve & maintain compliance with JPMDL requirements.
  • Understand changes to the Japanese law on Medical Devices
  • Understand GMP requirements within the new JPMDL
  • Understand requirements and implementation strategies under Ministerial Ordinance 169 (general QMS - Medical Devices as amended by Ministerial Ordinance 87) and Ministerial Ordinance 2 (Buildings and Facilities)
  • Obtain an in-depth gap analysis between ISO 13485 and MO 169
  • Understand the impact on the withdrawn Chapter 3 and Chapter 4 of MO 169/2004
  • Gain an overview of the new Chapter 3 – Additional Requirements and its impacts on MAH
  • Learn how to integrate JPMDL compliance with existing QMS
  • Understand the role of risk analysis under JPMDL and implementation requirements in J-QMS.
This course is designed for those whom need to develop and implement GMP according to the revisions to the Japanese Pharmaceuticals & Medical Device Law which has replaced the JPAL, Quality Managers, Regulatory Affairs Managers, Auditors of Medical Device manufacturing firms (internal and external) and Cross functional team members of implementation project
 
Participants will be led by an experienced trainer whom, in addition to being a medical device quality systems auditor and product approval reviewer, has nearly 3 decades of assessment, training and quality assurance as well as management system development experience.
This is a ​2-days programme.
​

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

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©  Ampro Solutions Sdn Bhd 2021
  • Home
    • About Us
    • Authorized Training Partner
  • Our Services
    • On-Site Training
    • Off-Site Training
    • Coaching
    • Audit Support
    • Consultation Services >
      • Energy Management >
        • Remote Power Management Services
      • Management Systems >
        • ISO 50001 Energy Management System
        • ISO 9001 Quality Management System​
        • ISO 14001 Environmental Management System
        • ISO 45001 Occupational Health and Safety Management System
        • IATF 16949 International Automotive Task Force
        • ISO/IEC 17025 Testing and Calibration Laboratories
        • ISO 13485 Quality Management for Medical Devices
        • AS 9100 Quality Management System for Aerospace Industry
        • ISO 20000 IT Service Management
        • ISO 22301 Business Continuity Management
        • ISO 31000 Risk Management
        • ISO 37001 Anti-Bribery Management System
        • ISO 55000 Asset Management
        • TL 9000 The Telecom Quality Management System
        • Food Safety Management System
        • Integrated Management System (IMS)
      • The Malaysian Standard for Sustainable Palm Oil Production (MSPO) >
        • General Differences between MSPO and RSPO
        • Deadlines for MSPO Certification
        • MSPO Certification Process
        • Photo Gallery
      • Business Continuity Management >
        • How We Can Assist You
      • Halal Certification >
        • Certification Scheme
      • Safety and Health Officer Support
  • Training Courses
    • Soft Skills >
      • Leadership & Supervision Skills
      • Motivation & Teambuilding
      • Communication & Interpersonal Skills
      • Presentation & Public Speaking Skills
      • Clerical & Administrative Skills
      • Customer Relationship Management Skills
      • Negotiation Skills
      • Sales & Marketing
      • Creative Thinking & Problem Solving
      • Human Resource
      • Microsoft Office
    • Business Management >
      • Purchasing & Logistic
      • Supply Chain Management
      • Process Improvement & Core Tools
      • Responsible Business Alliance (RBA)
      • Lean & Six Sigma
      • Electrical & Electronics
      • Project Management
      • Industry 4.0
    • Manufacturing Operations >
      • ISO 50001 Energy Management System / Energy System
      • ISO 9001 Quality Management System
      • ISO 14001 Environmental Management System
      • ISO 45001 Occupational Health and Safety Management System
      • ​IATF 16949:2016 International Automotive Task Force
      • ISO/IEC 17025 Testing and Calibration Laboratories
      • ISO 13485 Quality Management System for Medical Devices
      • AS 9100 Quality Management System for Aerospace Industry
      • ISO 22000 IT Service Management
      • ISO 22301 Business Continuity Management
      • ​ISO 31000 Risk Management
      • ​ISO 37001 Anti-Bribery Management System
      • ​ISO 55000 Asset Management
      • Food Safety Management System
      • TL 9000 Telecom Quality Management System
      • Integrated Management System
    • Health & Safety >
      • Occupational Health & Safety
      • First Aid
      • Fire Safety
      • Transportation Safety
    • Malaysian Standard for Sustainable Palm Oil Production (MSPO)
  • Events
    • Remote Online Training
    • Public Training in Johor Bahru
    • Public Training in Kuala Lumpur
    • Online Registration
  • External Info
    • Human Resource
    • Environment
    • Health & Safety
  • Contact Us
    • Career Opportunities