The Medical Device Single Audit Program
In October 2013, the Therapeutic Goods Administration (TGA) announced 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.
On January 1, 2015, the MDSAP pilot program was opened to manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. Japan will enter the MDSAP later this year as a full member, and the program will be open also to medical device manufacturers interested in marketing in Japan.
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 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.
Under the pilot, audits will be conducted by recognized third-party organizations, and medical device regulators in the participating countries will be able to use these inspection reports when making their regulatory decisions.
Manufacturers can benefit from the MDSAP pilot by cutting down on the number of regulatory audits they have to host, thereby minimizing manufacturing plant and personnel disruptions. This form of international and standardized oversight lessens the burden on manufacturers by bringing more consistency and transparency to the regulatory process.
The MDSAP pilot does not increase regulatory requirements for medical device manufacturers – the audits cover only existing requirements of the regulatory authorities participating. In many cases, these requirements are already harmonized or very similar to one another, such as the international standard for medical devices quality management systems (ISO 13485:2003), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the U.S. Quality System Regulation (21 CFR Part 820), and other specific pre- and post-market regulatory requirements of the authorities participating in the MDSAP pilot.
The TGA and other participating regulators will accept MDSAP audits as a substitute for routine audits for all classes of medical devices requiring a QMS audit, including in vitro diagnostic devices, although in the US, pre-approval inspections for devices requiring premarket approval applications (PMAs) and “for cause” compliance inspections will not be part of the MDSAP pilot.
Manufacturers that choose to participate in the pilot program will help to shape the policies and procedures of the fully operational MDSAP, which is scheduled to begin in 2017.
Now that the TGA has removed the requirement for Australian manufacturers to apply to TGA for a Conformity Assessment Certificate, the MDSAP offers an attractive mechanism for supply of Australian medical devices in a global marketplace.
