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.
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.