Course Description

The ASEAN Common Submission Dossier Template (CSDT) and Its Contents

Course Description:

This course provides a detailed look at recommendations for the format and content of the ASEAN Common Submission Dossier Template (CSDT). The content of the ASEAN CSDT is prescribed in the ASEAN Agreement on Medical Device Directive, signed by representatives of the 10 ASEAN member states in November 2014.

This course also provides mapping and detailed comparison of the CSDT to the Summary Technical Documentation (STED), a set of guidelines developed by the Global Harmonization Task Force (GHTF) and now maintained under the International Medical Device Regulatory Forum (IMDRF). It also provides guidance on what manufacturers must include in CSDTs.

Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Gain an understanding of what documentation is required for developing Common Submission Dossiers (CSDs) in accordance to the CSDT
  • Develop a CSD for submission to the appropriate regulatory authority

Who Should Enroll:

The following are encouraged to participate in this course:

  • Regulatory affairs and quality assurance professionals with an interest in the ASEAN market, or markets to which compliance to the CSDT is a regulatory requirement.
  • Manufacturers seeking to access markets in ASEAN countries, or markets to which compliance to the CSDT is a regulatory requirement
  • Regulators involved in developing and implementing regulatory systems for medical devices

Prerequisite Knowledge/Requirements:

A basic understanding of widely-adopted medical device regulatory framework(s) – either the GHTF model for regulation of devices or the ASEAN AMDD regulatory framework on which it is based.

Subject Matter Expert:
Tan Ming Hao

70 min

Related resources:

Case studies:

Basic Account: € 200.00
Premium Account: € 150.00

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