hsa Archives

Apr 12, 2024

HSA Guidance on Product Registration Submission Preparation: Device Description and Summary

The new article outlines the scope of information to be included in the device description and executive summary sections of the submission.

HSA Guidance on Product Registration Submission Preparation: Specific Aspects

Apr 12, 2024

HSA

HSA Guidance on Product Registration Submission Preparation: Specific Aspects

The new article clarifies the scope of information to be included in the submission to ensure all the essential matters are adequately addressed, the submission is complete, and the authority has all the necessary information to make the regulatory decision.

HSA Revised Guidance on Medical Device Product Registration: Specific Aspects

Feb 19, 2024

HSA

HSA Revised Guidance on Medical Device Product Registration: Specific Aspects

The new article highlights specific points related to medical device registration in Singapore under the existing legal framework.

HSA Revised Guidance on Medical Device Product Registration: Class A and B

Feb 19, 2024

HSA

HSA Revised Guidance on Medical Device Product Registration: Class A and B

The new article describes in detail the approach to be followed when applying for registration and marketing approval for Class A and B medical devices.