Australia TGA Publishes Finalised Guidance Document on Examples of Regulated and Unregulated Software

Therapeutic Goods Administration (TGA) Australia has published the finalised guidance document on examples of regulated and unregulated software in August 2021.   The guidance document presents examples that illustrate …

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Philippines FDA Issues Circular on the Reference List of Class A Medical Devices

The Philippines Food and Drug Administration (FDA) has issued Circular No. 2021-017 on the 16th of August 2021, to guide manufacturers, importers, distributors, and other stakeholders in the medical device industry regarding the list …

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Australia TGA Publishes Document on Refinements to the Personalised Medical Device Framework

Therapeutic Goods Administration (TGA) Australia has published a document regarding the refinements to the personalised medical device framework in August 2021.  After a public …

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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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Australia TGA Publishes Finalised Guidance Document on Regulatory Changes for Software Based Medical Devices

Therapeutic Goods Administration (TGA) Australia has published the finalised guidance document on regulatory changes for software-based medical devices in August 2021.  The guidance provides a …

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Philippines FDA Issues Circular on Guidelines for the Transition Period for Medical Device to the ASEAN Harmonized Technical Requirements

This Circular issued on 9 August 2021 aims to provide guidelines for the transition period of medical devices covered by FC No. …

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Singapore HSA Publishes Regulatory Guideline for 3D-Printed Medical Devices

On 15th July 2021, HSA has finalised the Regulatory Guideline for 3D-printed medical devices. A separate FAQ has been compiled …

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Hong Kong DOH Updates List of Recognised Standards for Medical Devices

In May 2021, Hong Kong Department of Health updated the RS-01: List of Recognised Standards for Medical Devices  Medical devices …

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Hong Kong DOH Updates Guidances for Listing of General Medical Devices and IVDs

In April 2021, Hong Kong Department of Health updated the guidances for listing of Class II/III/IV General Medical Devices and Class B, C and D In Vitro Diagnostic …

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