EMERGO SUMMARY OF KEY POINTS:

• ANVISA adds National Standards Authority of Ireland (NSAI) to its list of organizations accredited to perform quality management system audits according to MDSAP requirements
• Several auditing organizations now accredited to perform MDSAP audits in Brazil

Brazilian medical device regulators have recognized the National Standards Authority of Ireland (NSAI) as accredited to conduct quality system audits under the Medical Device Single Audit Program (MDSAP).

Now, according to the Brazilian government’s Official Diary (link in Portuguese), medical device manufacturers may hire NSAI to audit their quality management systems for compliance not only with Brazilian Good Manufacturing Practices (BGMP) but also MDSAP quality requirements applicable in the US, Canada, Australia and Japan.

NSAI’s MDSAP accreditation in Brazil will remain valid until June 15, 2019. Besides NSAI, ANVISA has also accredited organizations including DEKRA Certification, DQS Medizinprodukte, LNE G-Med, BSI Group America, TÜV SÜD America and Intertek Testing Services.

Additional ANVISA and MDSAP resources from Emergo:

• Brazil ANVISA registration support for medical device companies
• BGMP quality system compliance support
• Whitepaper: Brazilian medical device registration and MDSAP compliance