Singapore HSA Publishes Finalised Medical Devices Product Classification Guide

The Health Sciences Authority (HSA) Singapore published the latest Medical Devices Product Classification Guide in November 2021, to assist with …

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Singapore HSA Publishes Updates on Technical Reference for Submission of In Vitro Diagnostic Medical Devices

The Health Sciences Authority (HSA) Singapore published a latest update on medical device technical reference, discussing about the contents of a product registration submission for In …

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Singapore HSA Announces Update on Regulatory Fee Revision for Health Products

The Health Sciences Authority (HSA) Singapore has announced a critical update regarding the revision of the regulatory fee for health products, which was published on the …

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Singapore MOH, HSA, and IHiS Publish Guideline on Artificial Intelligence in Healthcare

The Ministry of Health (MOH), the Health Sciences Authority (HSA), and the Integrated Health Information Systems (IHiS) have co-developed and published a guideline on artificial intelligence (AI) in October …

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Singapore HSA Publishes Updated Document on Technical Reference for Product Registration Submission for General Medical Devices

The Health Sciences Authority (HSA) Singapore has published an updated document on medical device technical reference, focusing on the contents of a product …

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Singapore HSA Publishes Document on Common Questions for Generic Drug Applications

The Health Sciences Authority (HSA) Singapore has published a document on the common questions received for Generic Drug Applications in September 2021. The document highlights …

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HSA Singapore Revises Drug Master File Submission Process in GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION

With effect from 1 September 2021, applicants are required to submit the HSA’s acknowledgement email on the receipt of the …

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HSA Singapore Introduces an Online Self-Guided Tool for Post-approval Minor Variation Applications

HSA Singapore has launched on 20 August 2021 a new online self-guided tool for post-approval minor variation applications (MIV) to help industry stakeholders …

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Singapore HSA Published Finalised Guidance on the Medical Device Unique Device Identification (UDI) System 

Singapore HSA has published the finalised Guidance on the Medical Device Unique Device Identification (UDI) System on 27 August 2021.   This guidance document …

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