Course Description

Course Description

This course is one part of an online learning series on the Singapore medical device regulations. Singapore is an important economic hub in South-East Asia. Its healthcare delivery system is technology-driven and one of the most advanced in the world. In Asia, Singapore is regarded as a leading nation in spearheading a comprehensive regulatory framework governing medical devices. The Health Sciences Authority (HSA), its regulatory body, is an active member and contributor of the ASEAN Harmonisation Working Party (AHWP) for medical devices and the International Medical Device Regulators Forum (IMDRF). In Singapore, medical devices are controlled using harmonised regulatory policies and risk-based principles.

This course covers topics on the regulatory procedures required for the import and sale of medical devices in Singapore. This includes:

  1. An overview of the regulatory framework
  2. The product authorisation and review
  3. Dealer license registration
  4. Postmarket vigilance and mandatory reporting

Why is this course essential to take?

This course is essential for organisations who plan to place medical devices on the Singapore market. It enables an understanding of the organisation's regulatory responsibilities in registering its products and sponsors. This includes grasping the concept for medical device risk classification and the corresponding technical documentation requirements. The HSA also lays out routes for shorter regulatory evaluation for product owners who meet certain approval criteria. Guidance documents can be downloaded from this course for additional information.

Requirements and Pre-Requisites

  • Basic knowledge in medical device regulations

Topics covered in this course

  • Legislation and principles underpinning the Singapore regulatory framework
  • Statutory responsibilities of the Health Sciences Authority
  • Brief overview on the medical device risk classification
  • Product registration and condition for exemption
  • The product registration application route
  • Submission of technical documentation and dossier template requirements
  • Criteria to qualify for shorter evaluation routes
  • Dealer establishment registration
  • Postmarket vigilance requirements
  • Requirements for handling adverse events
  • Adverse event reporting timeline

Course Materials Provided

  • Health Product Act 2007
  • Health Products (Medical Devices) Regulations 2010
  • GN-13: Guidance on the Risk Classification of General Medical Devices
  • GN-14: Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices
  • GN-15: Guidance on Medical Device Product Registration
  • ASEAN Common Submission Dossier Template

Who Should Take This Course

  • Medical Device Startups
  • Regulatory Affairs Professionals
  • Technical Sales and Marketing Professionals
  • Business Development Professional
  • Investors
  • Consultants

Medical Device Coach

Nealda Yusof

My name is Nealda. Over the past 15 years I've helped dozens of medical device businesses in Asia grow through my consulting and training programs. With background in research, regulatory, testing & validation, quality assurance, risk and crisis management, compliance and commercialisation, my passion is to develop training courses in easy-to-understand and accessible formats to increase adoption of principles & best practices, improve compliance, encourage continuous improvement and promote understanding of the medical device sector. I am constantly on a quest to find better ways to comply with regulations, be more productive and promote a knowledge-based workforce in this sector — which is exactly what I’m going to teach you.

Course curriculum