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Mexico: Paths to approval for product that is CE-marked, but not FDA approved?

S

Start-Up Exec

#1
We are based in the US and do all of our manufacturing here. We have an implant that is Class IIb in Europe and has been CE-marked for a while, but we are still working on FDA approval. Since we cannot currently get a certificate of free sale from the country of origin, what options do we have for marketing approval in Mexico that would not involve a clinical study?

Some suggestions have been:
1. Establish a legal entity in Europe and do an OEM/PLM arrangement to have that European company be the legal manufacturer (per MDD) of the product - then get a CFS from the PLM country.
2. Have a company in a different country where we have marketing approval (e.g., Costa Rica) do the final packaging and perhaps sterilization, and call that the country of manufacture.

Any experience with this problem, and these or any other solutions?
 
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P

pourshams

#3
Hi,
We have CE mark for our medical devices (class I) and they are manufacturing in china (We do not have 510k), do you guys have any suggestion about a company that can represent us in Mexico and also does our registration?

we are willing to do the process ourselves but the COFEPRIS-04-001-B is Spanish and none of us know Spanish. anyone has gone through the process themselves?

Thanks
 
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