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.