NSF Health Sciences Certification LLC, a wholly owned subsidiary of NSF International, was recently authorized as an official Auditing Organization (AO) by the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council.
 
MDSAP is a global auditing and monitoring program to improve safety and oversight in manufacturing non-active, active, active implantable and in-vitro diagnostic medical devices. The authorization 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, which include Australia, Brazil, Canada, Japan and the United States.
 
The authorization is the culmination of a lengthy effort by NSF International’s Medical Device Regulatory Certification (NSF-MDRC) program staff. In addition to the application process, AO authorization requires a rigorous, two-stage assessment by regulatory authorities.
 
“This third-party audit model allows for greater coverage in auditing manufacturers around the globe,” said Kim Trautman, executive vice president of Medical Device International Services at NSF International. “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.”
 
Australia’s Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) utilize MDSAP audit reports as a substitute for their regulatory inspectorates’ reports for medical device applications or authorizations. Health Canada utilizes 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.”
 
MDSAP will pass a major milestone on Jan. 1, 2019, when the Canadian Medical Device Conformity Assessment System (CMDCAS) will be sunset and an MDSAP audit certificate will be required for manufacturers marketing products in Canada. This is expected to create greater urgency for manufacturers who wish to become certified in 2018 so they can continue marketing their medical devices in Canada.
 
NSF International’s Medical Device Regulatory Certification Program has assembled an internationally recognized staff with decades of regulatory authority and auditing experience in the United States, Canada, Japan, Brazil, and the European Union. Some NSF experts are former regulators who were directly involved in developing the MDSAP program requirements. With such expertise and long-standing relationships in the international medical device arena, NSF International understands the fast-changing regulatory landscape.
 
“When working with NSF International’s expert team, manufacturers can be sure that MDSAP audits will be performed both ethically and comprehensively,” said Robert Ruff, executive director, Medical Device Certification and Training at NSF International.
 
MDSAP certification allows manufacturers to promote their commitment to quality and regulatory compliance, which can be strategically beneficial for access to markets for current and future sales. Due to the multitude of audits manufacturers must undergo, this translates into a savings of time and money as resources are better utilized and interruptions to manufacturing schedules are minimized. Attaining MDSAP certification is paramount to manufacturer success, as it represents an internationally-recognized high standard in demonstrating regulatory compliance to users, customers, suppliers and the regulatory authorities themselves.
 
NSF International is an independent, global organization that writes standards, and tests and certifies products for the food, water, health sciences and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide.
 
NSF International’s health sciences services ensure pharmaceutical, biologics, medical device and dietary supplement products meet requirements as defined by regulatory bodies and standards agencies. NSF Health Sciences Certification, LLC, is an authorized Auditing Organization (AO) providing MDSAP certification and auditing services.