Session 1

1

Concept of Medical devices

Definition, terminology and classification

2

Safety, risk and assessment of   medical devices

Basic concept, influential factors, tools, standards

3

Effectiveness and assessment of medical devices

Concept, pre-test requirement, animal model, testing methods, report

4

The standards and role of standards for medical devices

Definition, classification, and guideline

Session 2

5

Introduction to UDI

Introduction, guideline

6

System requirements related to use of UDI

General System Requirements for Recording the UDI & Use Case

7

Common Data Elements for Medical Device and Data Elements for UDI

Definition，Elements

8

Labelling for Medical Devices

Definition, Principles

Session 3

9

Guidelines of Assessment for Medical Devices

Guidelines, principles

10

Clinical Evaluation for Medical Devices

Definition, Principles

11

IVD Devices and Assessment

Standards, procedures and evaluation

12

Clinical Evaluation of Software as a Medical Device (SaMD)

Standards, procedures and evaluation