Rating 4.25 out of 5 (10 ratings in Udemy)
What you'll learn- 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 …
Rating 4.25 out of 5 (10 ratings in Udemy)
What you'll learn- 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
DescriptionCourse 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:
- An overview of the regulatory framework
- The product authorisation and review
- Dealer license registration
- 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.
