MMD-112 An Overview of 21 Japanese Pharmaceuticals & Medical Device Laws
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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.
Outline
- 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- Understand the impact on the withdrawn Chapter 3 and Chapter 4 of MO 169/2004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.
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Ampro believes that the key to a successful and rewarding career is continuous professional development. We have a flexible approach to your training needs with regardless of whatever your requirements, we promise you a high level of service with packages that meet the needs of your business.
As a forward thinking company we deliver training at all levels, thereby supporting your company at every stage of its development. Courses can be delivered onsite at a location of your choice, costs dependent upon location and numbers, or at hotel.
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We are determined in developing new programmes and staying on-point with industry's trend, while maintaining exceptional quality standards.
When we commit to something, we’re totally devoted. Whether it’s our dedication to our clients; or to maintain at the leading edge of training services we offer; we are always dedicated to our task.
Our People
All our staff are highly motivated professionals, experienced and qualified in their own specialist areas, who are committed to works towards common goals.
Our trainers and consultants are quality assure and have been tested on their ability to deliver top-quality programmes. ...
Our Company Values
We are determined in developing new programmes and staying on-point with industry's trend, while maintaining exceptional quality standards.
When we commit to something, we’re totally devoted. Whether it’s our dedication to our clients; or to maintain at the leading edge of training services we offer; we are always dedicated to our task.
Our People
All our staff are highly motivated professionals, experienced and qualified in their own specialist areas, who are committed to works towards common goals.
Our trainers and consultants are quality assure and have been tested on their ability to deliver top-quality programmes. ...
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