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US FDA "Single Audit Program" and Brazil

M

MIREGMGR

#1
Some Background:

I was asked yesterday by Kim Trautman of FDA to participate in the Medical Device Single Audit Program (MDSAP). The company for which I'm Regulatory Manager has been a participant in the Voluntary Audit Report Submission Pilot Program (VARSP) for the past two years, and MDSAP is the descendent developmental program for the international harmonization group at FDA.

The participating regulators in MDSAP are US FDA, of course, plus:

Australia -- Therapeutic Goods Administration
Canada -- Health Canada
Brazil -- Agencia Nacional de Vigilancia Sanitaria

Japan MHLW/PMDA are "observers" at present, and are expected to fully participate soon. EU participation apparently is on hold while they figure out how this will interact with the shift to the MD Regulation.

My question for the Brazil experts here is:

For a company with no physical presence in Brazil, but with an interest in marketing low-risk-class devices there and with an ANVISA clearance process well underway for one such product family through Emergo, what is the regulatory significance of ANVISA participation in MDSAP?

My understanding is that the ISO 13485 certificate resulting from an MDSAP audit process may carry an MDSAP endorsement akin to Health Canada's CMDCAS endorsement. What is the Brazilian regulatory effect of such an endorsement?
 
#2
The MDSAP report will be used, for example, to issue a GMP Certificate without the need for ANVISA itself to inspect the plant abroad.

However, for classes I or II devices, there?s no need for a GMP certificate anymore, so in those cases I don?t see what to gain in the participation, from an ANVISA regulatory standpoint.
 

somashekar

Staff member
Super Moderator
#3
There is also this PMAP agreed between US FDA and HC.
How is this going about ?
The list of AO's as seen HERE are all not CMDCAS recognized registrars, unlike that in the MDSAP.
Is the pMAP active ?
Has the MDSAP taken off well ?
Of the 11 various AO's I contacted for an MDSAP, I have response from only three, and that with no MDSAP qualified auditor from Asia.
 
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