Medical Devices Single Audit Program (US, AUS, BR, CAN & JPN)

In the past, in order to licence the products in the USA, Australia, Brazil, Canada and Japan, medical device manufacturers need to demonstrate in different approval processes that they fulfilled the national regulatory requirements of each country. This was of course very costly and time-consuming. The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit conducted by recognized auditing organizations for medical device manufacturers that is accepted by the regulatory authorities of five different countries:

• United States Food and Drug Administration (FDA)
• Therapeutic Goods Administration of Australia (TGA)
• Brazilian Agência Nacional de Vigilância Sanitária (ANVISA)
• Health Canada (HC)
• 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)
• Quality System Regulation (21 CFR Part 820)
• Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)

The use of MDSAP certification:

• United States: FDA 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))
• Australia: 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 has recognised the MDSAP as the means to fulfil the quality management system requirements of the Canadian Medical Devices Regulation (CMDR SOR/98-282).
• Japan: MLHW and PMDA will use MDSAP audit reports in premarket and periodic post market audits.

The benefits of MDSAP certification:

• Reduces the number of audits and inspections a manufacturer must undergo.
• Minimises business disruptions and reduces costs.
• Accelerates entrance into some markets where traditional regulatory oversight can cause significant delays.

STEMart provides you with a single MDSAP audit that covers all relevant requirements of the regulatory authorities participating in the MDSAP and replaces multiple regulatory audits.

What We Do

• 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

STEMart provides a single MDSAP audit for medical device manufacturer to help them gain access to multiple markets. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.