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In Brief: US FDA, Brazil ANVISA Expand Lists of Qualified Audit Organizations for MDSAP

EMERGO SUMMARY OF KEY POINTS:

  • US and Brazilian medical device market regulators have updated their lists of organizations authorized to conduct QMS audits under the Medical Device Single Audit Program (MDSAP).
  • There are now four companies recognized as MDSAP auditing organizations and 13 organizations authorized by the US FDA to carry out audits.
  • Brazil’s ANVISA now recognizes nine MDSAP audit organizations.

Regulators in the US and Brazil have updated their lists of organizations approved to conduct quality system audits under the Medical Device Single Audit Program (MDSAP).

First, the US Food and Drug Administration now reports that 14 organizations have applied for authorization to conduct MDSAP audits in the US; 13 of those applicants have received such authorization, while only four have so far been formally recognized as MDSAP auditing organizations.

Second, Brazilian medical device regulator ANVISA has currently authorized (link in Portuguese) nine organizations to conduct MDSAP audits in Brazil.

Thus, MDSAP implementation continues apace; additional updates on the program will be provided as we learn them. Under MDSAP, regulators in five participating medical device markets—the US, Canada, Brazil, Australia and Japan—will recognize a single quality management system audit report conducted by an organization accredited to the program.

Related US, Brazilian and MDSAP information from Emergo

  • US FDA QSR consulting service for 21 CFR Part 820 medical device QMS compliance
  • Brazilian Good Manufacturing Practice (BGMP) implementation consulting
  • Whitepaper: BGMP requirements for medical device companies
  • Regulatory process chart for US FDA market applicants

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