S
Hello Medical Device Experts:
I have been asked to submit Certificate of Compliance for three most recent batches of our product by Mexican Regulatory authorities - as part of paperwork related to gaining approval in Mexico. Our product is ISO13485 certified & CE mark approved. The final product is assembled and released by a sub-contractor. Should we ask our sub-contractor to issue the certificate or should we do it, since, we are the Registered manufacturer and Specification Developer?
Also please let me know a template to use for the C of C.
Thanks,
SS from Norwood MA
I have been asked to submit Certificate of Compliance for three most recent batches of our product by Mexican Regulatory authorities - as part of paperwork related to gaining approval in Mexico. Our product is ISO13485 certified & CE mark approved. The final product is assembled and released by a sub-contractor. Should we ask our sub-contractor to issue the certificate or should we do it, since, we are the Registered manufacturer and Specification Developer?
Also please let me know a template to use for the C of C.
Thanks,
SS from Norwood MA
