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