Tag Archives: Japan

New Japan Medical Device Regulations

By Ames Gross

The new PMD Act was based on previous ordinances implemented in the summer of 2014. Two of the main points of this revision are to increase safety measures for medical devices and introduce new cellular and tissue therapeutic product regulations.

The new PMD Act was based on previous ordinances implemented in the summer of 2014. Two of the main points of this revision are to increase safety measures for medical devices and introduce new cellular and tissue therapeutic product regulations.

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The Key to Successfully Selling Medical Devices in China and Japan – Good Distributors

By Ames Gross

One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.

One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.

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Worldwide Medical Device Regulatory Updates

By Stewart Eisenhart

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.

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Devine Guidance

MHLW MO 169 – Chapter Two – Quality Management System

By Dr. Christopher Joseph Devine

There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.

There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.

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Devine Guidance

MHLW Ministerial Ordinance 169

By Dr. Christopher Joseph Devine

There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.

There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.

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