Medical Device Single Audit Program (MDSAP)

In 2012, the International Medical Device Regulators Forum (IMDRF) recognized the value in developing a global approach to auditing and monitoring medical device manufacturing. Specifically, this was done to ensure medical device safety. Consequently, a Medical Devices Single Audit Program was launched. Its primary purpose was “jointly leveraging regulatory resources to manage an efficient, effective and sustainable single audit program focused on the oversight of medical device manufacturers.”

International Medical Device Regulators Forum Medical Devices Single Audit Program, International Coalition Pilot Program sheet, January 2014

How MDSAP Works

When using the MDSAP, a medical device manufacturer first enlists a recognized Auditing Organization (AO). Subsequently, the AO conducts the audit of its QMS based on the regulations of five participating countries. These countries are Australia, Brazil, Canada, Japan, and the United States. Moreover, under the MDSAP, the manufacturer’s quality management system undergoes a single assessment every year. Meanwhile, the full certification cycle spans three years. As a result, this considerably reduces the number of audits and inspections. Therefore, manufacturers face fewer requirements from national regulators.

Country-Specific Implementation

However, each country decides how the MDSAP results apply in accordance with its laws. Currently, to date, only Canada has made the MDSAP mandatory. Indeed, it has been a requirement for class II, III, and IV medical devices (MDs) since January 1st, 2019.

Information Sharing

Finally, the MDSAP audit results (audit report) are systematically uploaded to a database. Thus, all participating regulatory authorities can access this database.

The MDSAP takes a global approach to quality management system audits and operates as an international coalition of countries dedicated to pooling resources, technologies, and services in order to improve safety and surveillance of medical devices around the world. Therefore, the MDSAP is useful for medical device manufacturers who want to market their devices in the five countries that participate in the program.

MDSAP Benefits

• Firstly, optimization of regulatory resources in one program to market your medical devices internationally in up to five countries: Japan, Brazil, Canada, Australia, and the United States;
• Moreover, ISO 13485:2016 certification for your company’s QMS compliance through the MDSAP;
• Additionally, participation in an evolving international program, with 2 new affiliate members recently joining: South Korea and Argentina.

The MDSAP is voluntary in Australia, Brazil, Japan, and the United States. However, it has been mandatory in Canada for class II, III, and IV medical devices since January 1^st, 2019.

Learn about MDSAP requirements in Canada (Health Canada)

When manufacturers decide to participate in the MDSAP, they must list, in the certification contract, the countries where they are and/or will be marketing their medical devices. Subsequently, during the on-site audit, the manufacturer’s QMS compliance is reviewed against the national regulations of those countries

Before obtaining certification, medical device manufacturers must list the countries where they market their product in their certification contract.

Medical Device Single Audit Program (MDSAP) Frequently Asked Questions, Version 016 of August 22,2017

The MDSAP audit criteria include the provisions of ISO 13485, as well as the related requirements of participating regulatory authorities. Moreover, other specific requirements from each regulatory authority may apply to products, licenses, company registrations, adverse event reports, etc.

Additionally, an important provision for those implementing the MDSAP is that manufacturers may exclude the requirements of a country in which they have no intention to market medical devices. Consequently, the MDSAP audit criteria include ISO 13485 provisions and only the regulatory requirements that apply in the MDSAP countries where the company sells or intends to sell its product.

CE marking certification is independent from MDSAP certification. Meanwhile, the European Union has an observer status and has no role in implementing the MDSAP. Nevertheless, both certification programs, however, can be conducted jointly.

This special status, created in 2019, allows countries to use MDSAP certificates or audit reports to evaluate medical device manufacturers’ quality management systems within their own regulations.

Moreover, as of the time of writing (March 2020), South Korea (Ministry of Food and Drug Safety) and Argentina (ANMAT) are the only affiliate members.