ACHIEVE ACCESS TO MULTIPLE MARKETS WITH A SINGLE AUDIT
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.
WHAT IS THE MDSAP?
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:
- Audits performed for MDSAP will be conducted in a consistent manner across auditing organisations.
- Audits will be conducted logically and efficiently, with attention to the interactions between processes.
- Auditors will be able to determine whether systemic quality management system nonconformities are present.
The MDSAP participating regulators include:
Australian Therapeutic Goods Administration (TGA)
TGA will use an 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 will utilise the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support the regulatory technical evaluation on these issues.
Health Canada (HC)
Health Canada's intent is to implement the MDSAP as the mechanism to assess regulatory compliance for quality management system requirements in Canada. As of December 31, 2018, Health Canada has terminated the Canadian Medical Device Conformity Assessment System (CMDCAS) program. Health Canada now only accepts MDSAP certificates for the purpose of Medical Device License application or maintenance.
US Food and Drug Administration, Center for Devices and Radiological Health (CDRH)
FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “for cause” or “compliance follow-up” by FDA will not be affected by this program. Moreover, MDSAP will not apply to any necessary pre-approval or post-approval inspections for the Pre Market Approval or 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) will use 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.
- Any manufacturer may participate if a product falls under the scope of at least one participating Regulatory Authority and will be subject to their quality management system requirements.
- Manufacturers located anywhere in the world are eligible to participate.
- Only the MDSAP participating countries will have direct access to the audit reports.
- Manufacturer's cannot select which of the 5 regulatory schemes are to be included within the audit scope. All country specific requirements of the manufacturer's target sale countries must be included. (This applies to the current 5 participating countries only - Australia, Brazil, Canada, US and Japan)
Note: Regulators will be witnessing some audits. This will be for the evaluation of the Auditing Organisation, not the manufacturer.
HOW CAN TÜV SÜD SUPPORT YOU?
TÜV SÜD Malaysia is authorised to work with clients who would like to participate in the MDSAP. 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.