Medical Device Single Audit Program (MDSAP)
Additional candidates can now apply for the MDSAP
The Medical Device Single Audit Program (MDSAP) Regulatory Authority Council (RAC) has announced (pdf,167kb) that, from 1 January 2017, additional candidate Auditing Organisations may apply for participation in the MDSAP in 2017. The current pilot phase will finish on 31 December 2016.
The MDSAP audit process was designed and developed to ensure and provide an efficient yet thorough coverage of the Quality Management System requirements implemented by medical devices manufacturers. These requirements are based on ISO 13485 – Medical devices - Quality management systems, and the specific requirements from the medical device regulations of the Regulatory Authorities that are participating in the MDSAP.
How to apply
The procedure for submitting the application can be found on the US Food & Drug Administration website: MDSAP Assessment Procedures and Forms.
Applications will be considered primarily on the quality of the application. If there is an excess of eligible candidates, consideration will be given to the depth and breadth of competence, and the order in which applications are received.
Due to the program’s operational limitations, a small number of successful applications from candidates already operating under a 3rd party medical device regulatory scheme will progress to further assessment stages in 2017.
If my application is declined
Where an Auditing Organisation fails during the application review or stage 1 assessment, the submission will be declined providing an opportunity for other candidates. Auditing Organisations whose applications are declined will be ineligible to reapply for a period of one year from the date of the refusal notification.
Medical Device Single Audit Program (MDSAP) mid-pilot report
21 September 2015
Following the commencement of the Medical Device Single Audit Program (MDSAP) Pilot in January 2014, the Mid-Pilot Report has now been released. The TGA has been participating in the Pilot alongside other international partners.
The MDSAP Pilot is intended to allow MDSAP recognised Auditing Organisations to conduct audits of medical device manufacturers that will satisfy the relevant requirements of the regulatory authorities participating in the pilot program. The pilot program is scheduled to run until December 2016.
The Mid-Pilot Report highlights the status of the objectives and performance goals defined to develop infrastructure, processes, training and stakeholder commitment necessary to launch the operational phase of MDSAP, scheduled for 1 January 2017.
Launch of the Medical Device Single Audit Program (MDSAP) pilot
22 October 2013
The Therapeutic Goods Administration (TGA) is pleased to announce the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil's Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration.
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.
The International Medical Device Regulators Forum (IMDRF) 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.
For many reasons not all IMDRF member countries are able to participate in the pilot at this stage, including changes of medical device legislation, the necessity to have in place country to country confidentiality agreements, etc. This does not diminish the support of all IMDRF member countries in the concept and, most importantly, in the development of the base documents being developed by the IMDRF MDSAP Working Group.
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 while minimising 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 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.
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 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 the third party auditing organisations.
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.
Further details on the operation of the pilot will be available prior to the start of the pilot.