An application submitted by NSF Health Sciences Certification, LLC, a wholly-owned subsidiary of global public health organization NSF International, has been accepted by the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council – putting the certification body on the path to becoming an MDSAP Auditing Organization. This is the first of three steps for NSF Health Sciences Certification, LLC to become authorized to conduct MDSAP audits. Authorization will help alleviate the backlog of audits that is expected as a result of Canada mandating MDSAP on January 1, 2019 and other global market and regulatory drivers.
 
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. Recognized MDSAP Auditing Organizations can conduct a single regulatory audit that covers 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.
 
Brazil, Japan and Australia utilize MDSAP audit reports as a substitute for their regulatory inspectorates’ reports for medical device applications or authorizations, while the U.S. Food & Drug Administration (FDA) uses them as a substitute for its regulatory inspectorates’ audit reports for routine FDA medical device inspections.
 
On January 1, 2019, Canada will require companies selling Class II, III and IV medical devices and IVDs in Canada’s approximately $6.7 billion market to have a MDSAP certificate to maintain their Medical Device Licenses. MDSAP will replace the current Canadian Medical Device Conformity Assessment System (CMDCAS) as a way to demonstrate quality management system compliance to ISO 13485 and the Canadian Medical Devices Regulations (CMDR).
 
At the same time, the world’s larger medical device manufacturers are setting internal requirements for their suppliers, including compliance with ISO 13485 or MDSAP. Additionally, the new EU Medical Device Regulations, which went into effect on May 26, 2017, require all EU notified bodies to become re-designated. With many of the MDSAP Auditing Organizations also being EU notified bodies, there will be a strain on resources to meet customer demands. These factors, as well as marketing pressures in other jurisdictions such as Brazil and Japan, will create a notable increase in the volume of regulatory audit work as well as a potential backlog that could impact manufacturer goals.
 
“Currently about five Auditing Organizations are handling nearly 90 percent of all CMDCAS certifications. With the change to MDSAP, there may not be enough Auditing Organizations to keep up with the work, which opens a pathway for audits from organizations such as NSF Health Sciences Certification, LLC,” says Kim Trautman, executive vice president of medical devices at NSF International. “MDSAP specifies Auditing Organizations must have expertise not only in the quality system but also in the manufacturer’s product type and design. Our staff holds notified body, regulatory authority and auditing expertise and had direct involvement in developing the MDSAP requirements or in implementing CMDCAS and MDSAP. We are well poised to meet the increased demand for manufacturer audits.”
 
NSF International experts include Trautman, a former U.S. FDA official who developed MDSAP and the MDSAP chairperson for its inaugural three years; Brian Ludovico who has over 20 years of experience in international medical device quality systems and certification requirements, including service as the chair of Health Canada’s Registration Body Forum under the CMDCAS Program; and James Pink who has experience serving as a lead auditor and product expert for a leading European notified body.
 
Currently, the World Health Organization Prequalification of In Vitro Diagnostics Programme and the European Union are observers to the MDSAP, which helps to build confidence in the Program and the possible expansion in jurisdictional membership in the future.