Course Description

The Hong Kong Regulatory System for Medical Devices

Course Description:

This course reviews Hong Kong’s background, the legislation behind their medical device regulations, special terms within their regulatory system, how to register a product in Hong Kong, and their grouping and classification system for devices.

At the end of this course, there is a complete and comprehensive demonstration of a hypothetical device undergoing Hong Kong’s regulatory system.

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Learning Objectives:

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

  • Recall the legislative history of Hong Kong’s device regulations
  • Gain a general understanding of Hong Kong’s medical system
  • Identify the steps needed to register a medical device 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 are encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

Learners should understand the basic medical device regulatory principles outlined in the GHTF/IMDRF documents and explained in the series of courses GHTF/IMDRF:

  • pre-market Regulatory Model (ID N170).
  • Post market regulatory model (ID N171)
  • Supporting documents (ID N172)
  • International Implementation (ID N173)
  • Essential principles of safety and performance of medical devices (ID N182)
  • STED and its contents (ID N187)

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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