Is ANVISA site certification not required for Class I and II devices ?

S

SGquality

Quite Involved in Discussions
For one of our site producing Class I and II medical devices and supplying to Brazilian markets, we had the site certified by ANVISA.

Now, we just heard that ANVISA has changed the regulations and those sites manufacturing Class I and II medical devices no longer require ANVISA site Certification.

Is this correct ?
 
M

Marcelo

Inactive Registered Visitor
Yes, since RDC 15/2014 ANVISA does not require the CBPF (GMP Certificate) for Classes I and II devices, they won?t even issue the certificate for Classes I and II.
 
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