NSF International’s NSF Health Sciences Certification subsidiary recently announced that it’s on the path to becoming a Medical Device Single Audit Program (MDSAP) Auditing Organization.
NSF said July 11 that the MDSAP Regulatory Authority Council had accepted its application, the first of three steps for NSF Health Sciences Certification to become authorized to conduct MDSAP audits.
Canada is making MDSAP audits mandatory for products sold after Jan. 1, 2019, so companies such as NSF expect an audits backlog. MDSAP will replace the present Canadian Medical Device Conformity Assessment System (CMDCAS).
“Currently, about five Auditing Organizations are handling nearly 90% 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,” Kim Trautman, EVP of medical devices at NSF International, said in a news release.
Outfits recognized as MDSAP Auditing Organizations can conduct a single regulatory audit that covers quality management system requirements in ISO 13485, as well as specific regulatory requirements of all participating jurisdictions, which include Australia, Brazil, Canada, Japan and the United States.
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