The FDA and Brazil’s National Surveillance Agency have added new auditing bodies to their list of organizations eligible to conduct quality management system audits for the Medical Device Single Audit Program.
The FDA now lists 14 organizations that have submitted applications to be auditors for the MDSAP program, which allows a single audit to satisfy multiple regulatory jurisdictions.
Only accredited auditing organizations under the Canadian Medical Devices Conformity Assessment System were allowed to apply during the MDSAP pilot from January 2014-December 2016.
One listed organization, NSF Health Sciences has not yet been authorized to conduct MDSAP audits. NSF was not allowed to apply until January 2017 and is the only auditing organization making it through the first several steps of the recognition process since the pilot concluded.
“We have received a successful Stage 2 Assessment which we are working with the Regulatory Authorities to conclude,” says Brian Ludovico, NSF executive director of MDSAP regulatory certification.
Of the 13 organizations cleared by the FDA to conduct MDSAP inspections, only four have received full recognition as MDSAP auditors: BSI Group America, Intertek Testing Services, TUD SUD America and UL Medical and Regulatory Services.
The full list of companies on the FDA’s list of eligible auditing organizations includes:
Current MDSAP participating countries are Australia, Brazil, Canada, Japan and the U.S. The MDSAP program allows regulators in MDSAP participating countries to share data so multiple GMP audits are not required in the participating countries (IDDM, July 12).
The International Medical Device Regulators Forum’s single-audit program remains on track for full implementation in 2019, and companies should be reviewing their internal auditing processes in preparation.
Brazil Adds Nine New MDSAP Auditors
Meanwhile, Brazil’s ANVISA added nine new organizations to its list of auditing bodies recognized to conduct MDSAP audits:
Devicemakers selling products in Canada must comply with the single audit requirement by March 2019. Health Canada will expect all device licenses to be supported by MDSAP audits by that time, and if a manufacturer doesn’t have a MDSAP certificate, its license will be suspended.
Companies selling devices in other regions covered by MDSAP should be aware that information from the Canadian audit will be shared with the regulators in the other regions. For example, if a company sells devices in Canada, the U.S. and Australia, it will be required by Canada to be certified under MDSAP, and the FDA and the TGA will have access to the
Other jurisdictions are likely to require MDSAP audits as the program gains momentum. The EU has not yet signed on because was overhauling its device regulations. As part of that process, it has toughened requirements for notified bodies, which will reduce the number of notified bodies to about 40 (IDDM, May 12).
Read the FDA list here: www.fdanews.com/09-06-17-FDAMDSAP.pdf.