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HSA Guidance on Change Notification: FSCA-related Changes and Exemptions

The new article highlights the aspects related to the changes to registered medical devices implemented in response to adverse events, the context of field...

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HSA Guidance on Change Notification: Categories of Changes

The article describes in detail the way the changes to medical devices are divided into categories and also highlights the key points to be...

HSA Guidance on Change Notification: Overview

The article provides a brief overview of Singapore’s regulatory requirements in the sphere of change notification for medical devices.  Table of...

HSA Guidance on GDP: Internal Audits and Outsourcing

The article highlights the key points related to internal audits and outsourcing activities.  Table of Contents The Health Sciences Authority (HSA),...

HSA Guidance on GDP: Counterfeit Devices and Complaint Handling

The new article highlights the approach to be applied concerning counterfeit medical devices, as well as the way the parties involved should handle complaints...

HSA Guidance on GDP: Good Assembly Practice and Traceability

The new article describes in detail the good assembly practice principles to be applied for medical devices and also provides additional clarifications regarding the...
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Exciting Digital Construction Industry Trends to Know About

Both the construction and technology industries are growing at rapid rates and this is great news for new and existing construction businesses. Construction site owners...

HSA Guidance on SAR: Post-Market Obligations and Summary

The new article provides additional clarifications regarding the regulatory matters related to post-market obligations, and distribution records, and also summarizes the regulatory requirements associated...

HSA Guidance on Standard GDP: Key Principles of Secondary Assembly

The new article highlights the main points related to the secondary assembly of medical devices intended to be marketed and used in Australia. In...

HSA Guidance on Special Access Routes: Requirements

The new article describes in detail the requirements associated with the special pathways to be used to make unregistered medical devices available for healthcare...

HSA Guidance on Good Distribution Practice: Delivery, Installation, and Servicing

The article describes in detail the aspects related to the delivery, installation, and servicing of medical devices and key points to be considered in...

FDA Guidance on Medical Device Patient Labeling: Warnings and Precautions

The new article addresses the aspects related to warnings and precautions to be included in medical device patient labeling.  Table of...
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