Issue with free sales certificate for implants from China

OPME Brazil

Registered
I’m helping a company in Brazil register Chinese orthopedic implants.
All is fine, except their FSC and I don’t know how to go about it…
The Chinese company’s free sales certificate issued by NMPA and certified by CCPIT will show a product’s name and model, and a range of measurements accepted for their manufacture and sale.
Issue with free sales certificate for implants from China

However, Anvisa will require that each measurement be linked to a specific code…
There’s been a lot of back-and-forth with the manufacturer about what the document needs to contain. We even worked together on the codes and approved the final document format, but they claim they have unsuccessfully tried every possible thing to get their FSC issued with the codes we needed… Any tips on how to work this out?
 

TimZhao

NMPAFocus
I’m helping a company in Brazil register Chinese orthopedic implants.
All is fine, except their FSC and I don’t know how to go about it…
The Chinese company’s free sales certificate issued by NMPA and certified by CCPIT will show a product’s name and model, and a range of measurements accepted for their manufacture and sale.
View attachment 28571
However, Anvisa will require that each measurement be linked to a specific code…
There’s been a lot of back-and-forth with the manufacturer about what the document needs to contain. We even worked together on the codes and approved the final document format, but they claim they have unsuccessfully tried every possible thing to get their FSC issued with the codes we needed… Any tips on how to work this out?
haha, i know the tricky thing. you only have the way to push the manufacturer to solve this issue. and i probably guess they do not have all codes approval :sneaky:
 
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