Hong Kong´s Regulatory System for Medical Devices
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.
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
Regulatory, marketing and quality assurance managers involved in product registration and compliance in Hong Kong.
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.