The Medical Device Single Audit Program was developed to allow recognized auditing organizations to conduct a single audit for medical device manufacturers that would be accepted by the regulatory authorities of five different countries:
- Therapeutic Goods Administration of Australia (TGA)
- Brazilian Agência Nacional de Vigilância Sanitária (ANVISA)
- Health Canada (HC)
- United States Food and Drug Administration (FDA)
- Japan's Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)
The MDSAP audit process covers all the requirements of:
- ISO 13485:2003 and ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes)
- Therapeutic Goods (Medical Devices) Regulations 2002
- Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)
- Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)
- Quality System Regulation (21 CFR Part 820)
It also covers other specific requirements of medical device regulatory authorities participating in the MDSAP program, including registration, licensing, technical documentation review and adverse event reporting.
The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program and the European Union (EU) are Official Observers of the MDSAP.
The mission of the regulatory authorities participating in the MDSAP is to jointly leverage regulatory resources to manage an effective, efficient and sustainable single audit program focused on the oversight of medical device manufacturers.
Their objectives 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 – minimizing regulatory and industry burdens without compromising public health
- To promote the more efficient and flexible use of regulatory resources through work sharing and mutual acceptance among regulators, while respecting the sovereignty of each authority
- To leverage, where appropriate, existing conformity assessment structures
- To promote, in the long term, a greater alignment of regulatory approaches and technical requirements, based on international standards and best practices
- To promote the consistency, predictability and transparency of regulatory programs
The MDSAP was launched on January 1, 2014, starting with a three year pilot that ended December 31, 2016. The operational phase of the program began on January 1, 2017.
Transition of CMDCAS to MDSAP
On December 4, 2015, Health Canada announced that it intended to implement MDSAP as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of Medical Devices Regulations.
MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even when a manufacturer intends to sell only in Canada. The period for transitioning from CMDCAS began January 1, 2017, after the conclusion of the MDSAP pilot, and will last for two years.
During this two year period, Health Canada will accept certificates issued under both CMDCAS and MDSAP. As of January 1, 2019, all CMDCAS certificates will be invalid, and only MDSAP certificates will be accepted.
How will regulatory authorities use the MDSAP and the resulting audit report and certificate?
- Australia: the TGA will use the MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements, unless the medical device is otherwise excluded or exempt from these requirements, or if current policies restrict the use of MDSAP audit reports
- Brazil: ANVISA will utilize the outcomes of the program, including reports, to provide input on ANVISA’s pre-market and post-market assessment procedures, including, where applicable, key information expected to support regulatory technical evaluations on these issues
- Canada: HC will use the MDSAP audit as part of its Canadian Medical Device Conformity Assessment CMDCAS certification program. HC will implement MDSAP as the mechanism for achieving regulatory compliance for quality management system requirements in Canada
- United States: the FCS Center for Devices and Radiological Health will accept MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted for cause or as compliance follow-up will not be affected by this program. The MDSAP program will not apply to any necessary pre-approval or post approval inspections for premarket approval (PMA) applications or to decisions under section 513(f)(5) of the act concerning the classification of a device (21 U.S.C. 360c(f)(5))
- Japan: The MLHW and PMDA will use MDSAP audit reports in premarket and periodic post market audits, which will lead to a reduction in the amount of documentation required for these audits
How can SGS help?
We will provide you with a single MDSAP audit that covers all relevant requirements of the regulatory authorities participating in the MDSAP and replaces multiple regulatory audits.
By participating in the MDSAP, you will:
- Gain access to multiple markets with a single audit
- Minimize business disruption, while optimizing time and resources
- Ensure complete coverage of the requirements of all five participating regulatory authorities
- Have routine audits scheduled directly with the auditing organization (AO)
Contact your local SGS office to find out more about participating in the program.