Japan Combination Medical Device Product Regulations and Requirements

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Nidhi V

Hi.

I am working on a Class III combination product that is not implantable and in which the primary mode of action is that of the drug's. I have been getting mixed inputs from several sources on the regulatory pathway for product approval.

I would appreciate any help in this regard!

Thanks,

Nidhi
 
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Nidhi V

Re: Combination product regulation in Japan

Thank you so much, Steve! Its definitely a start!
 
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