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Singapore: Regulatory Fee Revision for Health Products
On 1 December 2021, The Health Sciences Authority (HSA) revised the fee for health products....
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Medical Devices
COVID – Argentina Extended Period of Non-intervention of Chinstraps, …
Importation of chinstraps, masks, gloves and infrared thermometers: non-intervention period is extended. It is reported...
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Medical Devices
New Version of the Australian Therapeutic Goods Advertising Code
A new version of the Australian Therapeutic Goods Advertising Code (TGAC) has come into force...
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Medical Devices
Public Consultation Launched in China for “Measures for the Administr…
On 26 November 2021, the State Administration for Market Regulation of China published the “Measures...
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Medical Devices
EAEU Centralised Medical Devices Regulation Enters in Force on 1st January …
As of 1st January 2022, the Eurasian Economic Union (EAEU), formed by Belarus, Kazakhstan, Russia,...
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Medical Devices
EU: MDCG Publish Guidance Document on “Legacy Devices”
The Medical Device Coordination Group (MDCG) which is the expert panel of the EU Member...
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Medical Devices
New Circular on Issuance of Registration Number of Medical Devices Serving …
Circular No. 13/2021/TT-BYT dated September 16, 2021 prescribes dossiers and procedures for issuance of free-sale...
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Medical Devices
Health Canada Amended Certain Regulations Concerning Medical Devices
On 11 August 2021, HSA amended the Food and Drug Regulations and Medical Devices Regulations...
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Medical Devices
TGA Publishes Guidance Reclassifying Medical Devices in Direct Contact with…
The TGA has published a Guidance document: “Reclassification of medical devices in direct contact with...
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Medical Devices
Australia: The Claim ‘TGA approved’ Must Not Be Used in Adverti…
On 13 September 2021, the Therapeutic Goods Administration (TGA) emphasised that terms such as ‘TGA...
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