Overview:

Anvisa is a founding member of Medical Device Single Audit Program (MDSAP), that is a program for streamlining inspection resources in the area of health products, in which, instead of several health authorities inspecting the same plant, a single inspection is carried out by a third audit body. This body represents all these authorities participating in the program.

Besides Anvisa, the other participating health authorities are Therapeutic Goods Administration (TGA) of Australia; Health Canada of Canada; U.S. Food and Drug Administration (FDA) of the United States;  and Pharmaceuticals and Medical Devices Agency (PMDA) of  Japan.

Medical Device single audit Program (MSDAP)

According to a new report published by ANVISA in November 2019, Medical Device Single Audit Program (MDSAP) reached the mark of 5,000 participating companies in 2019. In addition, 48.7% of the total international certifications of health products issued by Anvisa in 2019 were made based on MDSAP program.

Additionally, the number of Brazilian Good Manufacturing Practice (BGMP) quality system certificates issued under MDSAP parameters has also grown substantially in the past two years: from less than five percent of BGMP certificates issued in 2017 to nearly 49% of certifications in 2019.

Figure 1: MDSAP Participating Manufacturer Sites (2019)

What does this mean for manufacturers?

The increase trend showed in the data could mean that  potentially Anvisa international inspections  might decrease and therefore, Anivsa would rather and  focus  its resources on the most  risky situations .

In addition to the resource economy, MDSAP represents  an  increase  of  the  safety  of  health products, as  auditing third parties inspect more companies and send their audit reports  annually  to  the  Anvisa’s and to the  other  authorities  participating  in  the  program as well.

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