Good Submission Practice:
IVD Product Registration Requirements in China

This module will introduce the learner to the Regulatory Authority structure in China and provide an update on the latest regulatory changes within the context of in-vitro diagnostic devices.
The module will also outline the different registration types and explore the new registration dossier requirements for IVDs.

English

100% Online

90 minutes

APACMed Certificate

Assessments

Interactive

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This module has been developed by
Victoria Qu

About this Module

Purpose
Learning Objectives
Target Audience
Module Structure
Assessment
Certificate

Why should I enrol in this Module?

This module will introduce the learner to the Regulatory Authority structure in China and provide an update on the latest regulatory changes within the context of in-vitro diagnostic devices. The module will also outline the different registration types and explore the new registration dossier requirements for IVDs.

Who should enrol in this Module? 

This Module is suitable for all Regulatory Affairs professionals or anyone with an interest in the regulation of medical devices.

How is this Module structured?

This is a self-paced, interactive Module.  It is divided into a number of individual topics so you can easily track your progress and manage your time.

You must watch all of the videos and presentations before the section will be marked as complete.

You can view the structure and individual topics below.

What kind of assessment do I need to do?

This Module contains a number of short knowledge checks and a final assessment.  

You will have unlimited attempts to pass each knowledge check.

What will I learn?

By the end of this module, you will have an understanding of:

  • the structure of the Regulatory Authority for Medical Devices and IVDs in China
  • the various IVD registration types
  • the latest IVD registration dossier requirements 

When will I get my certificate?

At the completion of the course you will immediately have access to the certificate from APACMed.