What is MDSAP?

The Medical Device Single Audit Program (MDSAP) is an initiative in which the five Regulatory Authority Council (RAC) countries, including Japan, jointly oversee Quality Management System (QMS) audits and utilize the QMS audit results provided by these auditing organizations across each RAC member country. In addition to the RAC, there are also Official Observers and Affiliate Members, with their respective countries (regulators) and roles outlined below.

Acquiring MDSAP and its benefits

Currently, only QMS audits using MDSAP are accepted for Class II or higher medical products in Canada. In the other four countries (Japan, Australia, Brazil, and the United States), MDSAP is optional; nonetheless, the RAC member countries continue to utilize MDSAP QMS audits.
Therefore, a manufacturer that is selling products in three countries, such as Japan, Australia, and the United States, will only need to undergo one QMS survey instead of three. In addition, manufacturers are free to select their preferred auditing organization from the accredited list.
Note that, in affiliate member countries, MDSAP audit reports and certificates are utilized for evaluations as defined by the methods specified by those countries, thereby alleviating the burden on manufacturers.

QMS standards across regulatory authorities

The QMS standards set by each regulatory authority include requirements that are unique to their respective countries and those aligned with ISO 13485.
The regulations for each country are listed below.

Auditing Organization

MDSAP audits are only conducted by auditing organizations accredited by the RAC.

Below is a list of auditing organizations that are currently approved.
Auditing Organization Availability to Conduct MDSAP Audits

Audit Approach

MDSAP audits are conducted in accordance with the document ”MDSAP Audit Approach.” This document describes specific methods used by auditing organizations to conduct MDSAP audits, as detailed in the following chapters.

• Chapter 1 – Management
• Chapter 2 – Device Marketing Authorization and Facility Registration
• Chapter 3 – Measurement, Analysis and Improvement
• Chapter 4 – Medical Device Adverse Events and Advisory Notices Reporting
• Chapter 5 – Design and Development
• Chapter 6 – Production and Service Controls
• Chapter 7 – Purchasing

Within each chapter, detailed explanations are referred to as “Tasks,” and the mappings to each country’s regulations and any specific additional requirements (differences) are also clarified.

Bear in mind that when using MDSAP, it is necessary to include all RAC member countries to which products will be shipped. Note that the regulatory requirements of RAC member countries where products will not be shipped are deemed unnecessary. Specifically, if shipping to Japan and Canada, MDSAP cannot be used solely for Canada; instead, an MDSAP audit is required for both Japan and Canada.

At SunFlare, we provide expert consulting services to help clients obtain MDSAP certification.

MDSAP audit cycle

After the initial full-scope QMS audit, partial surveillance audits are conducted annually for the first two years. In the third year, a full-scope re-audit, also commonly referred to as a recertification audit (renewal review), is conducted.

SunFlare also offers consulting services pertaining to any updates in the MDSAP Audit Approach.

Consulting services provided by SunFlare

To obtain MDSAP certification, SunFlare offers the following support services:

• Lectures on MDSAP requirements
• Consulting on decision-making regarding the use of MDSAP
• Gap analysis between the requirements and your current status
• Consulting on the development of a quality management system and creation of QMS-related documents, based on the use of MDSAP
• Consulting on operational support for quality management systems using MDSAP