Regulatory Open Forum

Greetings,

My company wishes to participate with another company in a humanitarian effort in Peru.  What steps need to be taken in order for this other company to donate product?  Do they need to register, even though it's a donation?  Their product happens to be CE marked, but not cleared by FDA.  Any guidance?

Thanks,

How will the devices get from your company to physicians/patients in Peru?  Are you planning to donate them directly to a healthcare provider located in Peru?  Or will you donate them to an organization that will distribute the devices in Peru?

I would tread somewhat cautiously here, due to political sensitivities about "dumping."

Greetings,

My company wishes to participate with another company in a humanitarian effort in Peru.  What steps need to be taken in order for this other company to donate product?  Do they need to register, even though it's a donation?  Their product happens to be CE marked, but not cleared by FDA.  Any guidance?

Thanks,

Greetings,

My company wishes to participate with another company in a humanitarian effort in Peru.  What steps need to be taken in order for this other company to donate product?  Do they need to register, even though it's a donation?  Their product happens to be CE marked, but not cleared by FDA.  Any guidance?

Thanks,

Greetings,

My company wishes to participate with another company in a humanitarian effort in Peru.  What steps need to be taken in order for this other company to donate product?  Do they need to register, even though it's a donation?  Their product happens to be CE marked, but not cleared by FDA.  Any guidance?

Thanks,

Hello Michael,

At the Latin American workshop at RAPS Convergence in San Jose, we will have the Peruvian regulatory authority present.

Are you attending it? if so, I suggest that you ask Ms. Sonia Marisol Cespedes directly.

If not, I would be pleased to ask this question and send her response to you.

Please let me know if you can wait until September.

Thank you.

Greetings,

My company wishes to participate with another company in a humanitarian effort in Peru.  What steps need to be taken in order for this other company to donate product?  Do they need to register, even though it's a donation?  Their product happens to be CE marked, but not cleared by FDA.  Any guidance?

Thanks,