Successful Product Approval in Singapore
The registration of medical devices in Singapore is of great importance to manufacturers seeking market access in ASEAN. After all, registration in this country sends a strong signal to the region. The well-established regulatory framework plays a decisive role in this regard.
In Singapore, the Health Sciences Authority (HSA) is responsible forthe safety and quality control of medical devices and for vigilance. The HSA regulates medical devices and in vitro diagnostic devices in accordance with the Health Products Act (HPA) and the Health Products (Medical Devices) Regulations 2010.
Medical devices in Singapore are divided into four risk classes: A, B, C, and D, with A representing the lowest risk class and D the highest. With the exception of some Class A medical devices, all medical devices must be registered in the national registry system (Medical Device Information Communication System, MEDICS). A prerequisite for this is approval by the HSA. For medical device manufacturers outside the country, a local representative is also required.
What makes our seminar unique?
In this interactive seminar, you’ll not only learn about the various requirements, but we’ll also use your products as examples to show you which approval process is right for you and how to navigate the approval process.
Numerous clear examples and practical tips will help you successfully obtain approval for your product in Singapore.
- Content
- Regulatory and Legal Requirements
- Organization of the HSA
- Overview of HPA Legislation
- Local Representative
- Access to the Singapore Market
- Product Classification
- Determining the Appropriate Authorization Procedure
- Quality Management Requirements
- Your Benefits
- You will learn about the various requirements for product approval in Singapore.
- You will walk through the approval process using your own product as an example during the seminar.
- You will understand the structure of the Health Sciences Authority (HSA) and know where to submit each application or registration.
- You will receive practical solutions tailored to 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
