Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the CFDA only makes these available in Chinese.
In Brief: Brazil Adds Two More Firms to MDSAP Medical Device Quality Inspection Program
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EMERGO SUMMARY OF KEY POINTS:
- ANVISA has accredited two more organizations to perform BGMP quality system inspections under the Medical Device Single Audit Program (MDSAP).
- MDSAP was scheduled to shift from its pilot phase to full implementation by regulators in the US, Brazil, Canada, Australia and Japan in early 2017.
Brazilian medical device market regulator ANVISA has added two more firms to its list of accredited inspectorsfor the Medical Device Single Audit Program (MDSAP).
The new additions are DQS Medizinprodukte GmbH of Germany and DEKRA Certification B.V. of The Netherlands (links in Portuguese). Accredited through December 31, 2018, the two organizations are now authorized to perform Brazilian Good Manufacturing Practice (BGMP) medical device quality system inspections recognized by ANVISA and other MDSAP participating regulators.
Full MDSAP implementation among participating regulators in the US, Canada, Brazil, Australia and Japan was slated for January 2017. Emergo will provide updates and analysis on implementation efforts among these participants as we learn them.
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