medical devices Archives

Feb 19, 2024

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.

FDA Guidance on Discontinuance or Interruption Notification: Specific Aspects

Feb 19, 2024

FDA

FDA Guidance on Discontinuance or Interruption Notification: Specific Aspects

The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.

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.

FDA Draft Guidance on Remote Regulatory Assessments: Details

Feb 19, 2024

FDA

FDA Draft Guidance on Remote Regulatory Assessments: Details

The new article provides additional details regarding specific aspects associated with remote regulatory assessments.

HSA Revised Guidance on Medical Device Product Registration: Overview

Feb 19, 2024

HSA

HSA Revised Guidance on Medical Device Product Registration: Overview

The article outlines the key points associated with registering healthcare products under the existing legal framework.

RegDesk Regulatory Roundup

HSA Revised Guidance on Medical Device Product Registration: Specific Aspects

FDA Guidance on Discontinuance or Interruption Notification: Specific Aspects

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

FDA Draft Guidance on Remote Regulatory Assessments: Details

HSA Revised Guidance on Medical Device Product Registration: Overview

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