Please note that the manufacturer of a class II device is not exempt to "complying"with the Brazilian GMP regulation. What happens is that a GMP certificate is not required for Class I and II registrations (cadastro). For all classes, manufacturers still have to comply with the GMP requirements.
The way MDSAP works in Brazil is that ANVISA can use the MDSAP report to give the GMP certificate (which is required for Class III and IV devices). So, there's no practical use for MDSAP in the case of Class I and II products right now.
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Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil
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Original Message:
Sent: 28-Jan-2018 18:03
From: Rashmi Pillay
Subject: MDSAP - Brazil
Hi,
For a Class II medical device , which is GMP exempt for Brazil (ANVISA) , does this exemption apply for MDSAP ?If we are marketing a Class II medical device to Brazil , do we have to comply with ANVISA requirements?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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