How to change the Manufacturing Site to another Contract Manufacturer

J

Jennifer0711

#1
Hi all,

I got a question that,

Our company is outside of Japan. We recently find a Japanese company who has already got a medical device license and also sell the product in japan. And he want us to be his contract manufacturer.

I know we need to apply "Foreign Manufacturer Accreditation", but no idea what to do next? Does anyone know how to notify PMDA that we would like to be a contract manufacturer? what document and how long it will take?

Thanks

Jennifer
 
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somashekar

Staff member
Super Moderator
#2
Hi all,

I got a question that,

Our company is outside of Japan. We recently find a Japanese company who has already got a medical device license and also sell the product in japan. And he want us to be his contract manufacturer.

I know we need to apply "Foreign Manufacturer Accreditation", but no idea what to do next? Does anyone know how to notify PMDA that we would like to be a contract manufacturer? what document and how long it will take?

Thanks

Jennifer
~~~ Welcome to the Cove Jennifer0711 ~~~
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