Like many other Asian countries, Hong Kong is developing a more regulated, harmonized system for medical device manufacturers and importers. Though registration is currently voluntary, manufacturers will soon be required to register their products. Get a head start by viewing our webcast and familiarize yourself with Hong Kong medical device regulations. Real case studies will be used to emphasize key points.
To view the webcast presentation slides in PDF format, please click on Hong Kong Medical Device Regulatory Update 2012 Webcast Slides.
This presentation will be made by Pacific Bridge Medical’s Hong Kong partner.
- Overview of Hong Kong Healthcare
- Hong Kong Medical Devices Market Industry
- Overview of Hong Kong Medical Device Regulations
- Hong Kong Regulatory Bodies
- Medical Device Classification
- Medical Device Administrative Control System
- Medical Device Application
- Labeling requirements
- CAB (Conformity Assessment Bodies)
- Local Responsible Person (LRP)
- Post-marketing surveillance and quality control
- Adverse Event Reporting
- Case Study
- Hong Kong Business Culture