Brazil Adds Ireland as MDSAP Accredited Auditor

July 12, 2017

Brazil’s National Surveillance Agency has added Ireland’s standards authority to its list of accredited organizations to perform quality management system audits under the Medical Device Single Audit Program.

The addition means that the National Standards Authority of Ireland may be contracted by devicemakers for compliance with Brazilian good manufacturing practices as well as MDSAP requirements in MDSAP participating countries, which are the U.S., Canada, Australia and Japan.

The MDSAP program allows regulators in MDSAP participating countries to share data so multiple GMP audits are not required in the participating countries.

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