The Therapeutic Goods Administration (TGA) launched the Medical Device Single Audit Program (MDSAP) pilot program, starting from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration (USFDA).
The TGA and MDSAP participation
The MDSAP is designed to ensure a single audit of a medical device manufacturer will provide efficient and thorough coverage of the diverse international regulatory requirements of medical device quality management systems, and other specific regulatory requirements. It represents an important milestone in regulatory cooperation and recognition.
Global approach to Regulatory Audits
The MDSAP is an initiative of the International Medical Device Regulators Forum (IMDRF), which recognises the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. At its inaugural meeting in 2012 IMDRF commenced work to develop specific documents for advancing the concept of MDSAP. This global approach opens possibilities and pathways to support the development of an international initiative of countries dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices on an international scale.
The mission of the IMDRF participants in the MDSAP international coalition is to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers. 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 (QMS) while minimising regulatory burden on organisations in the 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 standardising:
- oversight practices and procedures of participating regulators over third-party auditing organisations, and
- practices and procedures of participating third-party auditing organisations.
- To leverage, where appropriate, existing conformity assessment structures.
Inclusion of third-party auditors for regulatory compliance inspections
The development of the MDSAP includes the use of third-party auditors, much like some current regulatory audit programs, as well as regulatory inspectorates.
Recognising the increasingly global nature (and exponential number) of medical device manufacturers, the use of third-party auditors, in addition to Regulatory Authority Inspectorates, allows greater coverage in auditing manufacturers — as opposed to relying solely on the Government resources of individual countries.
The government resources can then be focused on high-risk or problematic medical devices, manufacturers that are not in compliance with the regulations, and oversight of third-party auditing organisations.
Compliance assessment of medical devices
The TGA announced (back in 2013), that it 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. It remains to be seen if and how MDSAP will fit into the reforms proposed to the pre-market assessment of medical devices in Australia.
Need to know more?
Further details on the operation of the pilot will be available on the TGA website prior to the start of the pilot.
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