Chapter 1 Background Information

1. Introduction

The Medical Device Single Audit Program (MDSAP) refers to the single audit program for medical devices in five countries: the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Australia (TGA), and Japan (PMDA). Its goal is to assess the quality management system of medical device manufacturers through a single audit to ensure that their products comply with the regulatory requirements of the participating countries. After completing MDSAP certification, companies can significantly reduce the number of audits conducted by regulatory authorities, minimize production disruptions caused by audits, and alleviate the burden on businesses.

2. Reference Documents

MDSAP AUDIT APPROACH

3. MDSAP Grading System

During MDSAP audits, nonconformities are rated on a scale of 1 to 5 points, and the final score is determined through the escalation rules of the nonconformity rating matrix. Nonconformity ratings are recorded in the "Standard Nonconformity Rating and Exchange Table," which also includes detailed information on how to obtain the final nonconformity rating based on ISO 13485.

4. Application Basis

MDSAP certification applications do not depend on whether other quality system certification certificates have been obtained, but having an ISO 13485 foundation will facilitate the MDSAP certification process.

5. Certification Application Language

English

6. Auditing Organizations (AO) Authorized to Conduct MDSAP Certification

Currently, there are 15 auditing organizations that can issue MDSAP certification certificates: BSI, DEKRA, DNV MEDCERT GmbH, DNV Product Assurance As, DQS MED, GMED, IMQ, Intertek, NSAI, NCC, SGS, TUV USA, TUV SUD, UL LLC.

Chapter 2 Certification Process

Document Preparation: Company basic information and application form, quality management system documents, documents related to the regulatory requirements of the target countries, design and development documents, production and manufacturing documents, after-sales service documents, risk management documents, internal audit records, and compliance proofs of relevant regulations and standards.

Chapter 3 FAQ

Q: Is it mandatory to apply for MDSAP in all five countries?

A: The scope of MDSAP application can be determined based on the target market of the enterprise. If a medical device is already or planned to be sold in a particular market, that country should be included in the application scope. It is important to note that Canadian regulations require that if there are no sales activities in Canada for three consecutive years, the AO will remove Canada from the MDSAP certification scope.

Q: What are the costs associated with MDSAP certification?

A: MDSAP certification costs are related to the size of the company and the scope of the application. There may be slight differences in quotations from different AOs. A complete quotation can be obtained by submitting specific enterprise information to the AO.

Q: What are the recommended documents and guidelines for MDSAP?

A: Enterprises can find MDSAP-related guidance documents on the FDA's official website under the MDSAP international topic at https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap.

Additionally, the following documents can be referenced:

Questions and Answers on the Medical Device Audit Program

MDSAP Audit Procedures and Forms - MDSAP-AU-P0002.009-2024

MDSAP International Regulations

Recent Announcements