Good Distribution Practice for Medical Devices in Singapore (GDMDS)

Provided by NUS Academy of GxP Excellence


Course introduction

Introduction


Objective

To create an understanding of GDPMDS certification for the distribution, importation, exportation and wholesaling of medical devices in Singapore to ensure that the quality and integrity of medical devices is not compromised during the process.

Description

As manufacturing industry grows with rising number of importation, distribution and wholesaling activities, it is a requirement that organizations involved should be in compliant with all applicable laws in force to ensure that the quality and integrity of the medical devices throughout the distribution process are not compromised. Hence, it is important that organizations be GDPMDS certified by certification bodies, accredited by the Singapore Accreditation Council (SAC) and recognized by the Health Science Authority (HAS) under Singapore context, before they can distribute those instruments and equipments. The course will provide an overview of what GDPMDS is about and the requirements necessary for organization to be GDPMDS certified will be the main focus of this course.

Course Outline

• Introduction to GDPMDS
• Product Regulations
• Overview of GN-01:Guidance on the Application of Good Distribution Practice for Medical Devices
  o Background
  o Quality Management System
  o Resource Management
  o Storage and Stock Handling
  o Medical Device Complaints and Field Safety Corrective Action (FSCA)
  o Internal Audits
  o Management Review
  o Outsource Activities
  o Secondary Assembly
• Overview of TS-01:GDPMDS Good Distribution Practice for Medical Devices – Requirements
  o Background and Terminology Definition
  o Interpreting Requirements of TS-01:GDPMDS - Clauses 2 to 13
• Understanding System Compliance
• Implementation Overview

Learning Outcome

Upon completion of this course the attendees will be able to:
1. Understand requirements in the TS-01:GDPMDS standards
2. Prepare for and manage GDPMDS audits and certification
3. Support organizations to comply with GDPMDS standards



Fees & Funding

Please enquire below for course fees and financial grants:




Brochure


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