EU: MDCG Publish Guidance Document on “Legacy Dev…
The Medical Devices Coordination Group (MDCG) which is the expert panel of the EU Member States and the EU Commission published on 20 Octobe…
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New Circular on Issuance of Registration Number of Medi…
Circular No. 13/2021/TT-BYT dated September 16, 2021 prescribes dossiers and procedures for issuance of free-sale registration numbers for m…
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Health Canada Amended Certain Regulations Concerning Me…
On 11 August 2021, HSA amended the Food and Drug Regulations and Medical Devices Regulations concerning shortages of Medical Devices and Med…
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TGA Publishes Guidance Reclassifying Medical Devices in…
The TGA has published a Guidance document: “Reclassification of medical devices in direct contact with the heart, central circulatory …
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Australia: The Claim ‘TGA approved’ Must No…
On 13 September 2021, the Therapeutic Goods Administration (TGA) emphasised that terms such as ‘TGA approved’ or ‘TGA regi…
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Legalization of Cannabis Cultivation in Brazil?
On 8 June 2021, the Brazilian Chamber of Deputies passed a bill authorizing the legalization of the cultivation of cannabis for medical, vet…
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FDA Philippines Seeks Feedback on Transition to New Med…
FDA Philippines published a draft for comments regarding the implementation of guidelines on the authorization for medical devices. The purp…
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US FDA provided requirement guidelines to allow three c…
US FDA provided requirement guidelines to allow 3 categories of medical device into market that rely on performance criteria to demonstrate …
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