AGENDA
DAY ONE
Morning Session
09:00 – 09:30 Module 1: Overview of Worldwide Medical Device Regulations (United States, Japan, Canada, Europe, ASEAN)
09:30 – 10:30 Module 2: Overview of ASEAN Medical Device Directive (AMDD)
- Definition of medical device acc to AMDD and Thailand Medical Device Act
- Classification of Medical Devices
10:30 – 10:45 Coffee Break
10:45 – 12:00 Module 2: Overview of ASEAN Medical Device Directive (Cont’d)
- Conformity Assessment Procedure
- Declaration of Conformity
Module 3: Structure of CSDT
- Executive Summary
- Essential Principles of Safety and Performance of Medical Devices and Method used to demonstrate compliance
12:00 – 13:00 Lunch
Afternoon Session
13:00 – 14:30 Workshop 1: How to select Harmonized Standards
14:30 – 14:45 Coffee Break
14:45 – 16:00 Module 3: Structure of CSDT (Cont’d)
- Medical Device Description
- Summary of design verification and validation
– Design verification vs design validation, Pre-clinical Studies
-END OF DAY ONE-
DAY TWO
Morning Session
09:00 – 10:30 Workshop 2: Categorization of devices and types of tests to be
performed on products
Module 3: Structure of CSDT (Cont’d)
- Summary of design verification and validation
– Clinical Evidence
10:30 – 10:45 Coffee Break
10:45 – 12:00 Module 3: Structure of CSDT (Cont’d)
- Summary of design verification and validation
– Risk Management
12:00 – 13:00 Lunch
Afternoon Session
13:00 – 14:30 Workshop 3: Risk Management
Module 3: Structure of CSDT (Cont’d)
- Manufacturer information
14:30 – 14:45 Coffee Breaks
14:45 – 16:00 Post –Training Examination
-END OF DAY TWO-