We are pleased to announce an upcoming free online training by WG 3 [Pre-Market: Software as a Medical Device] via Zoom on Software as a Medical Device (SaMD) Pre-Market Submission Requirement on 9th July 2025 by Mr. Winson Teng, Senior Manager, Regulatory Intelligence & Policy, Becton Dickinson and Company, Singapore.
In this training, Winson will provide an overview of the current regulatory requirements for SaMD pre-market submissions across selected jurisdictions.
*Note: It is intended as an educational resource to enhance awareness and understanding of the regulatory landscape. Please note that this document does not provide guidance or recommendations, but serves to inform stakeholders of existing practices.
No registration is required for this online training. Target audiences, regulators and industry who are interested, are welcome to join with the Zoom access as follows:
Time: 9th July 2025 (Wednesday), 16:00-17:00 (GMT +8)
Target audience: All GHWP members
Zoom Link: https://us06web.zoom.us/j/87249553150
Meeting ID: 872 4955 3150
Agenda:
| Time (GMT +8) | Topic | Speaker |
|---|---|---|
| 16:05-16:10 | Greetings & Opening | Mr. Chun-Jen Chein WG3 Chair |
| 16:10-16:40 | Software as a Medical Device (SaMD) PreMarket Submission Requirement – Comparison of requirement from Key jurisdictions | Mr. Winson Teng |
| 16:40-16:50 | Q&A | |
| 16:50-17:00 | Closing Remark | Mr. Chun-Jen Chein WG3 Chair |
Should you have any enquiry, please contact the GHWP Secretariat at secretariat@ghwp.info