The Hong Kong Regulatory System for Medical Devices
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.
Watch the Course Trailer:
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
Regulatory, marketing, and quality assurance managers involved in product registration and compliance in Hong Kong are encouraged to enroll in this course.
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)