SAC ISO 13485 compliance

• 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.

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• 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