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Health Sciences Authority
Regulatory Updates

Regulatory Sharing at SMF (23 November 2018)

Product type

Medical devices

28 March 2019

Summary of Regulatory Sharing at SMF (23 November 2018)

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

[Updated on 22 November 2018]
The Medical Devices Cluster will be sharing on some of our on-going updates to our Guidance
documents this year.
We have updated our guidance document on the Essential Principles of Safety and
Performance for Medical Devices in June 2018 after stakeholders’ consultation. We are now
working on updates to the guidance documents on Preparation of a Medical Device
Registration Dossier.
We will be sharing some of these updates during the SMF MTIG regulatory session on 23
November 2018.
The presentation slides are attached below: