Class III Medical Device (Contact Lenses) Registration Timescale in Japan

[flyjly]

Hi,

Our company is manufacturing and sales of soft contact lens which be classified as class III products in Japan.

We are applying Foreign Manufacturer Accreditation now. Does anyone know how long it will take for PMDA to approve? and also, how long it will take for PMDA to review our product registration documents (in STED format) after we get Foreign Manufacturer Accreditation?

Thanks
Eric

 

[Stijloor]

A Quick Bump!

Can someone help Eric?

Thank you very much!!

 

[Mondo 22]

Eric,

I have worked on all class registrations in Japan, you would be lucky to get registration within 2 years

 

[flyjly]

Dear Mondo 22,

Thanks so much for your information. Are you in Japan now? Can you recommend some companies to help to do the registration or to do the document translation? Thanks

 

[Mondo 22]

I am not based in Japan, to be honest you cant go wrong with emergo.

p.s. i dont work or have any association with emergo