Successful Medical Device Registration in Hong Kong
Currently, the registration of medical devices in Hong Kong is voluntary. So is registration simply an extra burden? Not quite. Registration offers advantages for manufacturers; for example, it will not be necessary to submit a complete technical dossier once the transition period ends. Additionally, clinics and users are more inclined to use registered medical devices. Furthermore, registration in Hong Kong is a prerequisite for participating in public tenders.
The Medical Device Division (MDD)is responsible for the registration of medical devices in Hong Kong. Registration takes place in the Medical Device Administrative Control System (MDACS) and is required for Class II medical devices and above.
What makes our seminar unique?
In this interactive seminar, you will not only learn about the various requirements, but we will also use your products as examples to show you which approval process is right for you and how to navigate the approval process.
Numerous illustrative examples and practical tips will help you successfully register your product in Hong Kong.
- Content
- Regulatory and Legal Requirements
- Organization of the MDCO
- Overview of the Legislation
- Local Responsible Person (LRP)
- Market Access in Hong Kong
- Product Classification
- Determining an Appropriate Authorization Procedure
- Quality Management Requirements
- Your Benefits
- You will learn about the various requirements for product approval in Hong Kong.
- You will walk through the approval process using your product as an example during the seminar.
- You will receive practical solutions for your business.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- RA Specialists
- QM Specialists
- Medical device developers and manufacturers
- Project managers
- Medical device manufacturers and exporters
