Four Countries to Participate in Pilot Program for Medical Device Audits – US, Canada, Brazil, Australia

Audit 2Four Countries to Participate in Pilot Program for Medical Device Audits (ODT Magazine)

FDA Announcement of MDSAP Pilot Program (FDA)

Australia’s Therapeutic Goods Administration (TGA) is teaming up with regulatory agencies in Brazil, Canada and the United States to launch a single audit program for medical devices.

The initiative — which will work in conjunction with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the U.S. Food and Drug Administration (FDA), is designed to ensure one quality management system audit is acceptable across multiple regulatory jurisdictions.

Currently, device manufacturers must comply with different quality system standards such as FDA’s Quality System Regulations in the United States, ISO 13485 in Europe and Brazil’s Good Manufacturing Practices (BGMP) in order to register their products in those markets. The Medical Device Single Audit Program (MDSAP) would spur more widespread use of third-party auditors alongside regulatory inspectorates, according to the TGA, to enable governments to focus their resources on higher-risk devices and adverse events.

Although the MDSAP pilot involves only Australia, Brazil, Canada and the United States, the program has the backing of the International Medical Device Regulators Forum (IMDRF), and additional IMDRF member countries eventually are expected to join the MSDAP.

The objectives for the MDSAP are:

  • To operate a single audit program that provides confidence in program outcomes.
  • To enable the appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing the regulatory burden on industry without compromising public health.
  • To promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority.
  • To promote, in the longer term, greater alignment of regulatory approaches and technical requirements globally based on international standards and best practices.
  • To promote consistency, predictability and transparency of regulatory programs by standardizing:– oversight practices and procedures of participating regulators over third party auditing organizations, and– practices and procedures of participating third party auditing organizations.
  • To leverage, where appropriate, existing conformity assessment structures.

The development of the MDSAP ideally would allow for greater coverage in auditing manufacturers as opposed to relying solely on the government resources of individual countries. Those government resources then can be focused on high risk or problematic medical devices, manufacturers that are not in compliance with the regulations, and oversight of the third party auditing organizations.

The Therapeutics Goods Administration will use an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorisation requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports.

The TGA will provide more details about the MDSAP pilot closer to the launch date.