Course Description

Hong Kong´s Regulatory System for Medical Devices

Course Description:

This course will review the background of Hong Kong, the legislation behind medical device regulation, special terms of the Hong Kong regulatory system, how to go about registering a product, the grouping & classification system of devices in Hong Kong, and will end with a complete walk through of a Hong Kong application using a hypothetical device as an example. 

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Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • recall the legislative history of device regulation
  • recognize, in general, how the medical system works in Hong Kong
  • identify the pieces needed to register in Hong Kong
  • demonstrate where to find information
  • explain how to register a product in Hong Kong and what supporting documents are required

Who Should Enroll:

Regulatory, marketing and quality assurance managers involved in product registration and compliance in Hong Kong.

Prerequisite Knowledge/Requirements:

Understand the basic principles as outlined in the GHTF documents (now IMDRF) and explained in the suite of courses SIDN25 GHTF/IMDRF Regulatory Model for Medical Devices.

Subject Matter Expert:
Jeremy Yung

72 min

Release date:

Related resources:

Case studies:

Basic Account: € 213.00
Premium Account: € 159.00

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