Medical Devices Latest Insights

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Internet Advertising Medical Devices Healthcare Computer

Medical Devices

Singapore: Regulatory Fee Revision for Health Products
15th February 2022

On 1 December 2021, The Health Sciences Authority (HSA) revised the fee for health products....

Medical Devices Gloves Infrared Thermometer Mask

Medical Devices

COVID – Argentina Extended Period of Non-intervention of Chinstraps, Masks, Gloves and Infrared Thermometers
15th February 2022

Importation of chinstraps, masks, gloves and infrared thermometers: non-intervention period is extended. It is reported...

Therapeutic Goods Medical Devices

Medical Devices

New Version of the Australian Therapeutic Goods Advertising Code
26th January 2022

A new version of the Australian Therapeutic Goods Advertising Code (TGAC) has come into force...

Internet Advertising Medical Devices Healthcare Computer

Medical Devices

Public Consultation Launched in China for “Measures for the Administration of Internet Advertising”
21st December 2021

On 26 November 2021, the State Administration for Market Regulation of China published the “Measures...

Brain Nervous System Medical Device

Medical Devices

EAEU Centralised Medical Devices Regulation Enters in Force on 1st January 2022
23rd November 2021

As of 1st January 2022, the Eurasian Economic Union (EAEU), formed by Belarus, Kazakhstan, Russia,...

Medical Device Diabetes Blood Test

Medical Devices

EU: MDCG Publish Guidance Document on “Legacy Devices”
23rd November 2021

The Medical Device Coordination Group (MDCG) which is the expert panel of the EU Member...

Healthcare Medical Tester

Medical Devices

New Circular on Issuance of Registration Number of Medical Devices Serving COVID-19 Epidemic Management
27th October 2021

Circular No. 13/2021/TT-BYT dated September 16, 2021 prescribes dossiers and procedures for issuance of free-sale...

Therapeutic Goods Medical Devices

Medical Devices

Health Canada Amended Certain Regulations Concerning Medical Devices
27th October 2021

On 11 August 2021, HSA amended the Food and Drug Regulations and Medical Devices Regulations...

Brain Nervous System Medical Device

Medical Devices

TGA Publishes Guidance Reclassifying Medical Devices in Direct Contact with the Heart, Central Circulatory and Central Nervous Systems
26th October 2021

The TGA has published a Guidance document: “Reclassification of medical devices in direct contact with...

Therapeutic Goods Medical Devices

Medical Devices

Australia: The Claim ‘TGA approved’ Must Not Be Used in Advertising
30th September 2021

On 13 September 2021, the Therapeutic Goods Administration (TGA) emphasised that terms such as ‘TGA...

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