MDSAP

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) represents an innovative, global approach to regulatory oversight of medical devices. It allows for a single audit, conducted by an authorized Auditing Organization (AO), to assess a medical device manufacturer’s quality management system against the requirements of multiple regulatory jurisdictions.

Under the MDSAP framework, a rigorous, comprehensive inspection is performed, covering all aspects of the medical device’s lifecycle, from design and development, to production, post-production, and distribution. It ensures a uniform interpretation of regulations and standards, thereby promoting a consistent level of quality and safety worldwide.

Participating Regulatory Authorities (RAs), including those from Australia, Brazil, Canada, Japan, and the United States, mutually recognize the outcomes of these audits. This streamlines the regulatory process, reduces administrative burdens, and fosters international collaboration, while maintaining a high level of public health protection.

In summary, the MDSAP serves as an efficient, cost-effective model that enhances global regulatory alignment and ensures compliance with stringent quality and safety standards, thereby improving the reliability and efficacy of medical devices in the marketplace.

Key Topics of MDSAP:

Audit Grading of nonconformities:

The MDSAP grading system has five grading levels and each nonconformity will be calculated with the following system:

Copy right by QUNIQUE GmbH and Regulatory Globe GmbH

Indirect nonconformities (Chapter 4.1 to 6.3) are the low-risk issues and normally starting with grading level 1 (first nonconformity) or grading level 2 (repeated nonconformity). Depends on the deviation, additional gradings can be put on top. For example, the deviation has an absence of procedure or it ends in a non-conformity product on the market (+1 Level each).

Direct nonconformities (Chapter 6.4 to 8.5) are the high-risk issues and starting at grading level 3 (first nonconformity) or grading level 4 (repeated nonconformity). Depends on the deviation, additional gradings can be put on top. For example, the deviation has an absence of procedure or it ends in a non-conformity product on the market (+1 Level each).

When you will not pass the MDSAP audit:

If the Auditing Organization finds three or more 4 levels or one or more 5 levels.

Timeline after the Audit:

The timeline below shows steps to be taken to improve processes and procedures following the audit.

How to implement the MDSAP requirements?

Implementing the Medical Device Single Audit Program (MDSAP) within your organization using an Excel checklist involves several steps. Before starting, ensure you understand the requirements of MDSAP, which includes compliance with ISO 13485:2016 (the international standard for medical device quality management systems), and any specific regulations in participating countries.

Here’s a simplified step-by-step guide:

1. Understand MDSAP Requirements: Review the MDSAP Companion Document and Audit Model. These provide an overview of what auditors will inspect during an MDSAP audit.
2. Use our MDSAP Excel Checklist: This checklist should include the relevant clauses from ISO 13485, as well as the requirements from the MDSAP Companion Document and Audit Model.
3. Perform a Gap Analysis: Use your MDSAP Excel checklist to perform a gap analysis. Go through each requirement and evaluate if your company is currently meeting the requirement or not. Record your findings in the Compliance Status column and provide any relevant notes or evidence in the Evidence/Comments column.
4. Create a Plan of Action: For any gaps identified, write down the action needed to address them, assign a responsible person, and set a deadline for the action.
5. Implement the Changes: Follow your plan of action and monitor the progress. Update the checklist as changes are implemented.
6. Prepare for MDSAP Audit: Once you have closed all the gaps and updated your checklist accordingly, prepare for the MDSAP audit. Make sure all necessary documents are available and staff are trained on the requirements.
7. Perform Internal Audits: Regular internal audits will help ensure ongoing compliance and identify any new gaps that may arise.
8. Continuous Improvement: MDSAP should be considered a continuous process, with regular review and updates to the Excel checklist.

Please note that these are just simplified steps. Actual implementation may require a deeper understanding of MDSAP requirements, a structured approach, professional expertise, and consistent efforts.

MDSAP Audit Checklist Excel

Our MDSAP integration solution:

MDSAP vs ISO 13485:2016 Checklist – Click here to get our test version.

Current valid Audit Approach document – MDSAP AU P0002.009 (06. August 2024)

Freshly updated MDSAP Audit Approach document – MDSAP-AU-P0002.009:

​
​Changes from version 008 to 009:

Guidance for country-specific requirements for Australia (TGA) for:

• Management – Task 5 & Task 8
• Device Marketing Authorization and Facility Registration – Task 1, Task 2 & Task 3
• Measurement, Analysis and Improvement – Task 7 & Task 12
• Medical Device Adverse Events and Advisory Notices Reporting – Task 1 & Task 2
• Purchasing – Task 5
• Annex 4

have been edited or removed.   The responsibility for ensuring compliance with some applicable regulatory requirements for medical devices is specifically imposed on the Australian Sponsor by the TGA.  (ISO13485:2016 Cl 3.10 – Note 1).  Consequently, these requirements are not auditable under the MDSAP unless they are identified, in whole or in part, as customer requirements.

Removed references to MHLW MO169 harmonized to ISO 13485:2003 throughout the document.

Removed colored boxes and colored font throughout to comply with U.S. requirements for Section 508 of the 1998 amendment to the Rehabilitation Act of 1973.

Link to MDSAP Companion document

Recent MDSAP related updates

Extension of Remote and Hybrid Auditing Pilot – MDSAP AU P0036 (02. Agust 2024)

The MDSAP Organization has decided to extend the Remote and Hybrid Auditing Pilot from September 2024 to March 2025. More details can be read on the FDA webpage.

​