Management System And Guidelines

SS620:2016 Awareness Training (Good Distribution Practice for Medical Devices)

4 Hours

The SS 620:2016 (GDPMDS) serves as a guide on the quality management system for organisations involved in handling, storage, delivery, installation, servicing, secondary assembly and other related activities of medical devices. For wholesalers and importers of medical devices in Singapore, it is a requirement to complete a 3rd party audit and attain the SS 620:2016 GDPMDS certification before applying for the dealers’ license issued by the Health Sciences Authority (HSA) of Singapore. 

Upon successful completion of the course, participants will be familiar with the structure of the standard and have a clear understanding of the Clauses under Good Distribution Practice for Medical Devices (SS 620:2016) and its applications.

Course Outline

  • Objective and purpose of SS620
  • Introduction to Good Distribution Practice for Medical Devices (SS 620:2016)
  • Differences between department of standards, Certification body and Accreditation body
  • Transition Time, Purpose of Change, Objective of Change
  • Good Distribution Practice for Medical Devices (SS 620:2016) requirements
  • Internal Audit

Who Should Attend

This course is designed and aimed for quality managers, executives, management representatives or any personnel within an organisation who wishes to setup and implement business processes based on the SS 620:2016 (GDPMDS). This also applies to individuals who are involved in organising and conducting internal audits for SS 620:2016 GDPMDS.

Prerequisites

This course does not have any pre-requisite units for entry.

Exam and Certification

  • Participants will need to complete a four-hour live training. and assessment at the end of the course. 
  • Participants will be required to achieve at least 80% of total marks in the assessment.
  • An electronic Certificate of Completion will be awarded upon successful completion of the online assessment.