MDSAP survey

Overview

The TGA is seeking feedback from Australian Sponsors about the Medical Device Single Audit Program (MDSAP). By completing this survey, your response will help us to better understand any concerns with the operation of the program. Sponsors may reach out to applicable Manufacturers for help answering specific questions on audit activities if necessary, although the intent of the survey is to better understand the Sponsor interactions during MDSAP audits.

The following survey should be completed by Sponsors who represent Manufacturers, either in Australia or overseas, that have been audited by an MDSAP Auditing Organisation, and have relied upon, or intend to rely upon, MDSAP Certification of the Manufacturer to support their initial application for inclusion of a medical device in the Australian Register of Therapeutic Goods, or to meet the ongoing conditions that apply to an inclusion.

PLEASE NOTE - Your responses will ONLY be used for information-gathering to inform further refinements to the MDSAP Audit Approach and the regulatory framework. Information collected in this survey will not be used for compliance activities.

Overview and Background to MDSAP

The Medical Devices Single Program (MDSAP) has been fully operational since 31 March 2016. Its vision is to “Develop, manage and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions.”  The participating Regulatory Authorities (MDSAP consortium) are from Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW/PMDA) and the United States (US FDA).(see MDSAP P0001.002: Functional Statement) (note that US FDA PMA approved devices are excluded from the MDSAP).

MDSAP Audits are performed by third-party Auditing Organisations (AOs) who have completed a formal recognition process including an assessment of their knowledge, skills, and experience in the field of medical device regulatory auditing (see AO Availability To Conduct MDSAP Audits).

The MDSAP AOs are required to complete training on the way in which the MDSAP consortium requires audits to be conducted, is based around compliance with ISO13485:2016, and includes the country specific requirements for each regulator. The method for conducting these regulatory audits is documented in the MDSAP Audit Approach (see MDSAP AU P0002.008 Audit Approach).

MDSAP certification has been identified as an overseas regulator conformity assessment document that is issued by an overseas regulator after that regulator is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to a medical device by the Manufacturer of the device. The MDSAP Auditing Organisations are recognised as one of the types of “overseas regulators” whose audits, using ISO13485:2016 as audit criteria, are comparable to an audit by the TGA of the Quality Management System requirements of the Australian conformity assessment procedures.

Further information about the MDSAP is available at the MDSAP Home page and the MDSAP Documents page.

You can subscribe through the link on the MDSAP Documents landing page to receive a notification by email when MDSAP website documents are updated.

The TGA can be contacted using the email link mdsap@health.gov.au if the Manufacturer requires clarification on Australian specific requirements.

If this survey raises any concerns from the Manufacturer about the way in which they have been audited under the MDSAP, then they should be advised that they can appeal a finding. An Auditing Organisation is required to manage appeals received from the Manufacturer according to ISO/IEC 17021. 1:2015 Cl 9.7.