Welcome! I’m Syafina Y., a Regulatory Affairs professional passionate about simplifying complex medical device submissions for Malaysia and Singapore. With hands-on experience in over 90 successful regulatory projects across all device classes, I bring structured strategies and submission-ready documentation that align with national and international standards. I enjoy bridging the gap between manufacturers and regulatory authorities to ensure smooth, compliant approvals. This blog is a space where I showcase my work, shares industry updates, and resources for anyone navigating the regulatory landscape.
Browse updates and insights on medical device regulations across multiple countries.