Japan Medical Devices Vigilance Regulations or Guidelines

A

alexandra_b

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
 
H

harry

Trusted Information Resource
Welcome to the Cove.

Please check the two related threads in the 'similar discussions threads' box below this page (just scroll down)
 
A

alexandra_b

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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