September 17, 2018

The published document titled “Tech: Enabling Regulatory Compliance- Supporting Innovation and Faster access to safe medical devices” contains the summary of regulations that are currently implemented in Singapore including the newly revised guidelines. The following topics included in the document is as follows:

1.       HSA’s role in Health Products  Regulation

2.       Regulatory Scope

3.       What are regulated Medical Device

4.       Key controls in entering Singapore Market

5.       Risk Based Approach

6.       Dossier Requirements

7.       Medical Product Lifestyle

8.       HSA’s Initiative

a.       Pre-Market Consultation Scheme

b.      Evaluation Route

Conclusion: The document is uploaded into their website for easy access to stakeholder to be aware of these changes and minimize the possible delay and confusion that may arise due to these new regulations