NSF International announced as MDSAP auditing organisation

Health standards organisation, NSF Health Sciences Certification has been authorised as an official auditing organisation (AO) by the Medical Device Single Audit Programme (MDSAP) Regulatory Authority Council.

The authorisation enables NSF International to conduct a single regulatory audit that covers the quality management system requirements in ISO 13485 and the specific regulatory requirements of all participating jurisdictions including the United States, Brazil and Japan.

The authorisation comes from the efforts of NSF International’s Medical Device Regulatory Certification (NSF-MDRC) program staff. NSF International’s Medical Device Regulatory Certification Program has assembled a group of international staff with regulatory authority and auditing experience. Some are former regulators who were directly involved in developing the MDSAP programme requirements.

Kim Trautman, executive vice president of Medical Device International Services at NSF International, said: “This third-party audit model allows for greater coverage in auditing manufacturers around the globe. The benefits are two-fold in that government resources can be focused on high-risk or problematic medical devices and manufacturers that are not in compliance with the regulations, and manufacturers will be able to have one audit to satisfy the requirements of all participating regulatory jurisdictions.”

MDSAP certification allows manufacturers to promote their commitment to quality and regulatory compliance.

Australia’s Therapeutic Goods Administration (TGA), Brazil's Agência Nacional de Vigilância Sanitária (ANVISA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), use MDSAP audit reports for medical device applications or authorisations. Health Canada utilises the MDSAP Certificate as part of its Class II and III licenses for market entry, and the U.S. Food and Drug Administration (FDA) uses them as a substitute for their regulatory inspectorates’ audit reports for routine medical device inspections.

“As the confidence in the reliability of third-party audits grows, other regulatory authorities will leverage this information to limit the need for additional audits,” said Brian Ludovico, executive director of Medical Device Regulatory Certifications at NSF International. “As it stands today, both the European Union and the World Health Organization Prequalification of In Vitro Diagnostics Program are official observers and other countries like Columbia and Mexico are exploring how they might use the outputs of the MDSAP audit.”