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japan, medical device standards and regulations, medical devices (general), vigilance system and requirements
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  #1  
Old 25th February 2013, 03:52 AM
alexandra_b alexandra_b is offline
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Please Help! Japan Medical Devices Vigilance Regulations or Guidelines

Hello all,

I'm looking for guidances or regulations, in English, about vigilance in Japan.
What are the manufacturer's responsibilities? What is the role of the legal agent?

Many thanks for your answers.

Regards,

Alexandra

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Old 25th February 2013, 04:03 AM
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Re: Japan Medical Devices Vigilance Regulations or Guidelines

Welcome to the Cove.

Please check the two related threads in the 'similar discussions threads' box below this page (just scroll down)
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Old 25th February 2013, 04:19 AM
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Re: Japan Medical Devices Vigilance Regulations or Guidelines

Thanks Harry,
But, the posts you referred concern principally European requirements et refer to Meddev.
I know Japanese regulations are very different from European.
Actually, we are currently in the registration process of our devices in Japan, and I want to make sure I'm aware of all specific requirements. In case of incident, how is responsible? How must report incidents?
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Old 25th February 2013, 04:27 AM
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Re: Japan Medical Devices Vigilance Regulations or Guidelines

Japan Medical Devices Regulations

Japan Combination Medical Device Product Regulations and Requirements

??
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Old 25th February 2013, 04:45 AM
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Re: Japan Medical Devices Vigilance Regulations or Guidelines

Will this help - Good Vigilance Practice (GVP) - Japan - English translation and explanation of ............

Otherwise, you will have to wait for further response.
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