MDSAP Certification Unlocks Global Market Access for Medical Device Manufacturers

Discover how to achieve successful Medical Device Single Audit Program (MDSAP) certification to market medical devices in Australia and globally. Find out more.

Demand for medical devices continues to grow steadily worldwide. Industry statistics show the global medical device market is growing at over 5 percent annually, with projected global revenue expected to reach over US$673 billion by 2029^[1]. Factors such as aging populations and technology advancements are creating profitable markets for medical device manufacturers. However, ensuring medical devices comply with the local rules and regulations of multiple markets has historically been disruptive, time consuming and expensive.

Gaining competitive edge with MDSAP

In January 2017, this all changed when the MDSAP program was officially implemented. MDSAP helps manufacturers gain a competitive edge in the global market through a single audit solution that saves both time and costs. The MDSAP program unifies global regulatory efforts across five major markets, streamlining the audit process for manufacturers by eliminating the need for separate country-specific audits. This harmonized approach simplifies the pathway to market medical devices in participating jurisdictions.

MDSAP also fully covers the requirements of ISO 13485, a globally recognized medical device certification standard, to demonstrate that a manufacturer’s management system can meet product safety and regulatory requirements. Achieving MDSAP certification demonstrates a manufacturer’s commitment to ensuring their products are safe and effective, instilling confidence for investors and end users, while also being hugely beneficial in supporting different market requirements. With these clear benefits in sight, the next step for many manufacturers is to consider how to prepare for compliance with the program. 

Which global markets does MDSAP cover?

The MDSAP created a coalition of countries to conduct one audit that all five participating regulatory authorities will accept:

• Therapeutic Goods Administration of Australia (TGA)
• Brazilian Agência Nacional de Vigilância Sanitária (ANVISA)
• Health Canada
• United States Food and Drug Administration (US FDA)
• Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)
• Manufacturers can add new jurisdictions from the list of five to their market as they grow, with little additional cost or effort. The World Health Organisation (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are official observers.

Key benefits of MDSAP

The MDSAP program offers many benefits, enabling you to:

• Gain access to multiple markets
• Reduce the overall number of audits with a single audit, optimizing time and resources spent on audit activities
• Demonstrate commitment to quality management systems, product quality and regulatory compliance
• Demonstrate commitment to safe and effective products
• Instil confidence for investors and end users
• Demonstrate the seriousness of product integrity in meeting the thorough requirements of this certification
• Receive two certificates, an ISO 13485 and an MDSAP certificate

Importantly, the program does not add any new requirements to the existing requirements of the ISO 13485 standard, or the medical device regulations of the participating authorities.

Readiness for MDSAP

Some challenges in preparing for MDSAP may include adhering to the timeframe, new levels of risk management, and additional requirements covering multiple jurisdictions. The following measures may help achieve success:

• Understand MDSAP requirements and conduct internal audits to identify potential nonconformities
• Conduct a gap assessment of your management system against MDSAP requirements
• Provide continuous internal training to give employees the knowledge and skills to understand and stay updated with evolving requirements
• Develop a comprehensive risk management program and prioritize risk management throughout the product lifecycle 
• Establish a robust QMS that meets the requirements of MDSAP and is aligned with ISO 13485
• Ensure required documents are organized and accessible

What is the audit process?

The MDSAP is based on a three-year audit cycle. The initial certification audit involves a complete audit of a medical device manufacturer’s quality management system (QMS), consisting of Stage 1 and Stage 2 audits. The initial audit is followed by a partial surveillance audit in each of the following two years and a complete recertification audit in the third year.

Special audits, audits conducted by regulatory authorities, and unannounced audits are potential extraordinary audits that may occur at any time within the audit cycle.

How does MDSAP affect Australia’s TGA assessments?

The TGA assesses MDSAP audit reports and certificates as crucial evidence for sponsors and manufacturers to demonstrate compliance with medical device regulatory requirements. The TGA will not usually audit manufacturers who have been audited under MDSAP. However, TGA reserves the right to audit any manufacturer supplying medical devices to Australia if necessary. The TGA needs the MDSAP certificates and audit reports to state that the manufacturer has been assessed and complies with the relevant aspects of the Therapeutic Goods (Medical Devices) Regulations 2002^[2].

For manufacturers applying for, or holding, a TGA conformity assessment certificate, that also has MDSAP certification, the TGA performs a desktop review of MDSAP audit reports. The desktop review also reviews other inputs, such as any additional supporting information provided by the applicant and whether TGA has received any post-market signals about devices from this manufacturer. If the MDSAP audit reports provide suitable evidence of compliance with the MDSAP audit approach, then the next scheduled TGA audit will generally be skipped. However, if the desktop review identifies gaps and is subject to the outcome of other TGA technical reviews, such as microbiology, engineering, biomaterials, or clinical assessments. In that case, the TGA may decide to perform a reduced scope or full onsite audit of the manufacturer.

How can SGS help?

As the world’s leading testing, inspection and certification company,  SGS Is recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories worldwide.

We have a history of successfully undertaking large-scale, complex international projects. We can help you:

• Understand the requirements with our MDSAP training courses
• Get an MDSAP audit
• Gain a comprehensive review of your QMS
• Leverage MDSAP's audit report to simplify QMS surveys

For further information, please contact:

Dora Mindakis
National Technical Sales Specialist
t: +61483334647