INTRODUCTION

The Medical Device Single Audit Program (MDSAP) was the initiative from the International Medical Device Regulators Forum (IMDRF). Developed to enhance the auditing and monitoring approach of medical devices manufacturing globally, MDSAP went through a 3-year pilot project from 1st January 2014 until 31st December 2016 and became a full program from 1st January 2017.

There are currently 5 MDSAP members and they are:

1. Therapeutic Goods Administration (TGA) of Australia
2. Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
3. Health Canada (HC)
4. Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)
5. S. Food and Drug Administration (FDA)

The MDSAP requirements are developed based on the 5 MDSAP members’ country’s regulated policies for medical devices with ISO 13485 Quality Management System requirements as the basis. MDSAP certification audit is performed by approved and authorized Auditing Organizations (AO) and the MDSAP certification is on a 3-year cycle.

COURSE OBJECTIVES

This course aims to give delegates in-depth knowledge regarding the Medical Device Single Audit Program (MDSAP) and the course content outlined is to provide delegates with information on:

• The background of MDSAP
• MDSAP members
• The MDSAP Companion Document
• The 7 processes in MDSAP and their interlinkages
• Auditing Organization (AO) and the MDSAP Certification
• The MDSAP audit approach and audit time determination

COURSE OUTLINE

Day 1

Opening and introduction

1. Background of Medical Device Single Audit Program (MDSAP)
2. MDSAP members, Official observers and Affiliate members

3. The 7 processes in the MDSAP
4. Management
5. Device Marketing Authorization and Facility Registration
6. Measurement, Analysis and Improvement
7. Medical Device Adverse Events and Advisory Notices Reporting

Day 2

Day 1 Recap

3. The 7 processes in the MDSAP (Continue)
4. Design and development
5. Production and Service Controls

Day 3

Day 2 Recap

3. The 7 processes in the MDSAP (Continue)
4. Purchasing
5. Auditing Organization and MDSAP Certification
6. The MDSAP audit approach and audit time determination
7. Course summary

COURSE BENEFITS

Upon completion of this training, delegates will: –

1. Be able to understand the structure and purpose of MDSAP
2. Have knowledge on the 7 processes in MDSAP and its interlinkages
3. Be able to understand Auditing Organization’s (AO) responsibilities
4. Be able to understand the audit approach for MDSAP based on the guidance document
5. Have knowledge on MDSAP certification and its benefits

DURATION

3 full-day course (9.00am -5.00pm)

MODE OF TRAINING

Online Training

TARGET AUDIENCE

This program is useful to delegates who are managing Medical Device Single Audit Program (MDSAP) compliances as well as internal auditors who are also auditing the MDSAP’s scope.