SAC ISO 13485 Compliance

Key takeaways: 

• Gain insights into the overview of the SAC ISO 13485 and how it addresses specific regulatory requirements for medical devices in Singapore
• Learn about the benefits of implementing SAC ISO 13485 to improve compliance with Health Sciences Authority (HSA) regulations and enhance market access 

With the introduction of Singapore Accreditation Council (SAC) ISO 13485, compliance with HSA regulations has become more critical for medical device manufacturers operating in Singapore as this will be mandated by the Authority starting 1 January 2025 to those who wish to renew or apply their license in the country. This standard ensures that products meet rigorous quality and safety criteria and streamlines regulatory processes, reducing the time and cost associated with market approval. Understanding and implementing SAC ISO 13485 is essential for organizations to maintain regulatory compliance, avoid potential fines, and ensure the safety and efficacy of their medical devices. This webinar will provide valuable insights into the importance of this new requirement and how to navigate its implementation effectively.

To view the webinar, fill up the form now. 

Our webinar will tackle these points, focusing on:

• Overview of SAC ISO 13485 and its relevance to HSA Singapore
• Detailed explanation of SAC ISO 13485 requirements
• TÜV SÜD accreditation scope
• TÜV SÜD certification approach
• Q&A session

About the speakeR

Ms. Amelia Ng, Medical Health Services Certification Manager

Amelia has over 16 years of extensive experience in quality management systems and regulatory affairs within the medical device industry. She has successfully guided numerous organizations through ISO 13485 and SAC ISO 13485 certification processes and is a renowned speaker in the field. Amelia is known for her practical approach to regulatory challenges. She brings valuable insights and expertise, especially in the context of certification bodies, ensuring compliance and quality in medical device manufacturing.

Learn more about ISO 13485 Quality Management System for Medical Devices we offer.