The Medical Device Single Audit Program (MDSAP) was developed by a group of international Medical Device regulators to allow recognized third-party Auditing Organizations (AOs) to conduct a single audit of a medical device manufacturer that will cover not only ISO 13485, but also their respective regulatory requirements. The MDSAP program covers the medical device regulatory requirements for Australia, Brazil, Canada, Japan and the U.S. and may be provided by NSAI in conjunction with EU auditing activities.
More information and documents about the International Medical Device Regulators Forum (IMDRF) and MDSAP are available on the IMDRF website and on the FDA’s website.
The regulatory authorities that are currently participating in the MDSAP Program are:
How will regulatory authorities utilize MDSAP audit reports?
Australia: The Therapeutics Goods Administration - TGA will use an 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: The Brazilian National Health Surveillance Agency – ANVISA will utilize the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues.
Canada: Health Canada – HC accepts the results of the Medical Devices Single Audit Program as the mechanism to achieve regulatory compliance for quality management system requirements in Canada.
Japan: MHLW and PMDA will utilize these audit reports in both premarket and periodical post market audit under regulations in Japan. Undergoing the MDSAP Pilot audits is expected .to reduce some burden on Japanese regulatory processes.
United States: U.S. Food and Drug Administration’s Center for Devices and Radiological Health – FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program. Moreover, this MDSAP program would 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 (21 U.S.C. 360c(f)(5)) concerning the classification of a device.”
Note: The European Union, China and Russia are members of the IMDRF Management Committee but are not participating in the program at this time.
MDSAP stands for Medical Device Single Audit Program. It is a program that allows medical device manufacturers to undergo a single audit that satisfies the regulatory requirements of multiple countries. The program was developed by the International Medical Device Regulators Forum (IMDRF), a group of medical device regulatory authorities from around the world.
The MDSAP program is designed to simplify the regulatory process for medical device manufacturers by allowing them to conduct a single audit that will cover not only ISO 13485, but also their respective regulatory requirements. The participating regulatory authorities include the United States Food and Drug Administration (FDA), Health Canada, the Therapeutic Goods Administration (TGA) of Australia, the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, and the Brazilian Health Regulatory Agency (ANVISA).
One of the main business challenges that the MDSAP program solves is the complexity and cost associated with meeting regulatory requirements for medical devices in different countries. In the past, medical device manufacturers have had to undergo multiple audits to comply with the different regulatory requirements of each country, which can be time-consuming and expensive.
The MDSAP program offers a solution to this challenge by allowing medical device manufacturers to undergo a single audit that satisfies the requirements of multiple regulatory authorities. This streamlines the regulatory process and reduces the cost and time associated with complying with different regulatory requirements.
Obtaining Medical Device Single Audit Program (MDSAP) Registration can offer several benefits to your business, including:
Reduced Audit Burden: MDSAP allows a single audit to be conducted for compliance with multiple regulatory authorities, reducing the burden of undergoing multiple audits.
Increased Market Access: MDSAP Registration enables your medical device to be marketed in the participating countries, including the United States, Canada, Brazil, Japan, and Australia.
Competitive Advantage: MDSAP Registration indicates that your organization has a robust quality management system that meets the requirements of multiple regulatory authorities, providing a competitive advantage over companies without MDSAP Registration.
Improved Quality Management: The MDSAP audit criteria are based on international standards and best practices for quality management, providing your organization with a framework to improve its quality management system.
Risk Management: MDSAP focuses on risk management, enabling your organization to identify and mitigate risks associated with your Medical Device more effectively.
Consistent Approach: MDSAP provides a standardized approach to auditing and reporting, ensuring consistency in the evaluation of your Medical Device across multiple regulatory authorities.
Overall, MDSAP Registration can help your organization streamline its regulatory compliance efforts, improve its quality management system, and expand market access, ultimately leading to increased customer satisfaction and business growth.
To obtain MDSAP certification an organization must complete the following steps:
Note: The MDSAP registration process can vary depending on the regulatory requirements of each country. It is essential to check the regulatory requirements of each country where you plan to market your Medical Device when applying for MDSAP registration.
Are you ready to streamline your regulatory compliance efforts, improve your quality management system, and expand your market access? If so, it's time to consider obtaining Medical Device Single Audit Program (MDSAP) registration certification with NSAI.
NSAI is a globally recognized certification body, Notified Body and recognized Auditing Organization (AO) that can provide accredited certification of your organization’s MDSAP system, ensuring that your business is fully compliant the regulatory requirements of the Medical Device industry.
Don't wait any longer to start taking advantage the benefits of MDSAP certification with NSAI. Contact us today to get started on the path to improved quality performance, cost savings, and enhanced reputation.
