Singapore HSA-Thai FDA Reliance Program for Medical Devices

THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

Watch now: Singapore HSA-Thai FDA Reliance Program for medical devices

Our Emergo by UL expert presents a comprehensive overview of the latest Thai FDA Reliance Program and its impact on facilitating the registration process in Thailand.

Webinar date

April 18, 2024

Speaker

Sreenu Sattu, manager QA/RA

This webinar will help you gain a better understanding of the latest Thai FDA Reliance Program and its impact on facilitating the registration process in Thailand, particularly for products with Singapore HSA approvals.

Learning objectives:

Overview of Singapore medical device regulations
Overview of Thai FDA regulations
Thai FDA Reliance Program and how it works

About the presenter

Sreenu Sattu, manager QA/RA

Sreenu Sattu has over 17 years of healthcare industry experience, focusing on medical devices and in vitro diagnostic devices, and covering products of all risk classifications. Sattu’s background includes establishing regulatory strategies for registrations, integration activities, compiling EU technical files, CSDTs for APAC submissions, U.S. FDA 510ks, and TGA submissions, including Clinical Evaluation Reports and Post Market Surveillance. He also has experience in ISO 13485 audits, gap assessments and US FDA QSIT Inspections.

In his current role, Sreenu manages the regulatory and quality compliance needs of Emergo’s APAC and international clients. Prior to joining Emergo by UL, he held regional and leadership positions at Life Technologies (now part of Thermo Fisher Scientific), Vela Diagnostics, Cardinal Health and Abbott.