Healthcare, Industry News, Medical Devices, Regulatory Affairs

ANVISA: Reached milestone of 5000 international health product certifications using MDSAP in 2019

Brazilian medical device market regulator, ANVISA, according to a recent report showed a significant increase in medical device manufacturers participating in the Medical Device Single Audit Program (MDSAP), with nearly half of all quality management system certifications issued in 2019 under MDSAP. According to the report, the Medical Device Single Audit Program (MDSAP) reached, in 2019, the milestone of 5,000 participating companies. In addition, 48.7% of the total international health product certifications issued by ANVISA this year were made using the program. The number of device manufacturing sites in Brazil that participate in was 3,225 in 2017 and 778 in 2017.

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