Save Time and Reach Global Markets with MDSAP

MDSAP IN A NUTSHELL

The Medical Device Single Audit Program (MDSAP) provides a single Quality Management System (QMS) audit to satisfy all participating regulatory authorities’ requirements.

REACH GLOBAL MARKETS

The goal is to create a coalition of countries that are dedicated to improving medical device manufacturing safety and oversight.

The program is one audit for compliance with the standard and regulatory requirements of:

• Australia
• Brazil
• Canada
• Japan
• The US
• Affiliate jurisdictions that use the MDSAP report, such as South Korea, Argentina, Singapore and others

WHAT ARE THE KEY BENEFITS?

There is a multitude of benefits, including:

• Access to multiple markets via a single audit, leading to improved patient health and access
• Minimized business disruptions from multiple audits
• The opportunity to leverage regulatory resources and save time and costs
• Routine audits scheduled with the Auditing Organization (AO), such as SGS
• The chance to incorporate ISO 13485 (medical device QMS) assessment
• Greater industry transparency

THE AUDIT PROCESS

The MDSAP is based on a three-year audit cycle. There is a complete initial audit of your QMS, surveillance audits in years one and two, and a re-audit in year three.

THE REGULATORY AUTHORITIES (RAS) INVOLVED

The MDSAP is perfect for global organizations wishing to export medical devices to the listed countries and affiliates.

The following is what each country’s RA says about utilizing MDSAP reports.

Australia

The Therapeutic Goods Administration (TGA) uses MDSAP audit reports as part of the evidence that is assessed for compliance with medical device conformity assessment procedures and market authorization requirements. This is unless the device is excluded or exempt from these requirements, or if current policies restrict using MDSAP reports.

Brazil

The Agência Nacional de Vigilância Sanitária (ANVISA) utilizes program outcomes, including reports, to constitute important input for its pre- and post-market assessment procedures. ANVISA provides, when applicable, key information that is expected to support regulatory technical evaluation concerning these issues.

Canada

Health Canada (HC) only accepts the MDSAP for manufacturers that market their devices in Canada. Therefore, manufacturers wishing to place a product in the Canadian market must have MDSAP certification from an AO.

Japan

The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) utilize MDSAP audits in pre- and periodical post-market audits under Japanese regulations.

The US

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) accepts MDSAP audit reports as a substitute for FDA routine inspections.

Inspections conducted “For Cause” or “Compliance Follow-up” by the FDA are not affected by the MDSAP. The MDSAP does not apply to any necessary pre- or post-approval inspections for Pre-Market Approval (PMA) applications or decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f) (5)) concerning the classification of a device.

WHO and the EU

The World Health Organization (WHO) prequalification of in vitro diagnostics (IVDs) and European Union (EU) are official MDSAP observers.

HOW WE CAN HELP

MDSAP audits are conducted by an AO, such as SGS, authorized by the relevant RA under the program’s requirements.

Our MDSAP audit covers the regulatory requirements of the five member jurisdictions and replaces multiple audits. Our experienced auditors can support you to bring any medical device to the Australian, Brazilian, Canadian, Japanese and/or US markets.

Affiliate participants may examine audit reports provided by the participating manufacturer.

Our MDSAP audit can be combined with CE and ISO 13485 assessments to save more time.

FURTHER SERVICES

In addition to our MDSAP service, we offer a range of solutions to act as the one-stop shop for all your medical device certification and testing needs.

Medical device certifications

Our services include:

• ISO 13485, medical devices – QMS – requirements for regulatory purposes
• Medical Device Regulation (MDR)
• 510(k) Third-Party Review (3P510k)
• Japanese Pharmaceutical Affairs Law (JPAL)
• UK Conformity Assessed (UKCA)
• Medical device training courses

Stay up to date on the latest medical device standards and regulations with SGS Academy’s series of training courses.

SGS Academy’s training solutions help organizations to improve personal competence and skills, as well as enable sustainable business development and a competitive advantage.

With expert trainers, training moves beyond theory to provide valuable real-world insights.

We offer:

• MDSAP Implementation
• Introduction to the new MDR – online
• MDR – implementing the changes
• MDR internal auditor
• MDR medical devices auditor/lead auditor
• MDR technical documentation
• ISO 13485 lead auditor
• ISO 13485 internal auditor
• ISO 13485 documenting and implementation
• ISO 14971 and ISO 31000 – adopting a product and process risk-based approach
• Medical devices clinical evaluation implementation
• Introduction to the new IVDR – online

Save time, reach global markets and put the patient first. Learn more here.