Be confident of medical device market approval
The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organisations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements are applicable to regulatory authorities, as well as third-party organisations that conduct such audits.
The objective of the MDSAP is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a Medical Device manufacturer, conducted by an MDSAP recognised auditing organisation, to satisfy the needs of multiple regulatory jurisdictions.
The participating regulatory authorities hope to achieve more consistency among the auditing organisations.
By following the MDSAP Audit Model:
The MDSAP program includes 5 participating regulatory authorities:
In addition, there are several observers and affiliate members of the program including:
MDSAP Official Observers:
MDSAP Affiliate Members:
Australian Therapeutic Goods Administration (TGA)
TGA uses the MDSAP audit report as part of the evidence that is assessed in compliance with Medical Device market authorisation requirements, unless the Medical Device is otherwise excluded or exempted from these requirements, or if current policy restricts the use of MDSAP audit reports.
The Brazilian National Health Surveillance Agency ANVISA
(Agência Nacional de Vigilância Sanitária)
ANVISA utilises the outcomes of the program, including the reports, as input to ANVISA’s pre-market and post-market assessment procedures, by providing, when applicable, key information that is expected to support the regulatory technical evaluation on these issues.
Health Canada (HC)
Manufacturers of medical devices in classes II, III or IV wishing to apply for or maintain a Medical Device Licence must demonstrate that their products are in compliance with the requirements of the Canadian Medical Devices Regulation (CMDR SOR/98-282). In addition, the manufacturer’s quality management system is required to be certified according to ISO 13485. By issuing an MDSAP certificate, we confirm that the manufacturer's quality management system is in conformity with ISO 13485 as well as Canadian Medical Device Regulations
US Food and Drug Administration, Center for Devices and Radiological Health (CDRH)
FDA accepts the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “for cause” or “compliance follow-up” by FDA are not affected by the program. Moreover, MDSAP does not apply to any necessary pre-approval or post-approval inspections for the Pre Market Approval (PMA) applications.
Japan Ministry of Health, Labor and Welfare
Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) uses the MDSAP audit report as a trial:
1) To exempt a manufacturing site etc.* from on-site inspection, and/or
2) To allow a Marketing Authorization Holder (MAH) to substitute considerable part of documents required for the inspection with the report.
a) A Registered Manufacturing Site (RMS) which manufactures medical devices made of human/animal tissues,
b) A RMS which manufactures radioactive IVDs, and
c) An establishment of a MAH.
Note: Regulators will be witnessing some audits. This will be for the evaluation of the Auditing Organisation, not the manufacturer.
TÜV SÜD is authorised to work with clients who would like to participate in the MDSAP. If you are interested in the audit program, please contact [email protected]
As the leading Certification Body in the medical device industry, TÜV SÜD takes a proactive approach in informing our customers about the regulatory changes concerning the industry. Follow us on TÜV SÜD's Medical Device Linkedin Showcase page to keep up to date with the latest developments concerning MDSAP.