Aesthetic Treatment Medical Devices in Japan

[Anders01]

Hi All,

I have a medical device that is used for aesthetic treatments only, which means that is is classified as a medical device in the US but not the EU. Can anyone tell me if it is subject to medical device regulations in Japan? I cannot seem to find much information on this topic. Thank you for any assistance.

[sreenu927]

The attached Pharmaceuticals Affairs Law (PAL) may be helpful to you in deciding whether registration is required or not.

Regards,
Sreenu

[Anders01]

Thanks for the response Sreenu. Do you know if there is any English guidance specifically for Medical Devices in Japan? I appreciate your response.