FDA Issues Final Guidances to Assist with Transition Pl…
The final transition guidances provide recommendations and clarity for medical device manufacturers that may or may not want to continue to …
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US FDA Issues Guidance of “Assembler’s Guid…
This document supersedes Assembler’s guide to diagnostic x-ray equipment: responsibilities of assemblers, distributors, and dealers of…
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Canada Updated Guidance on Applying for a Manufacturer&…
Health Canada implemented an electronic version of the manufacturer’s certificate to export on January 5, 2022 as a pilot project whic…
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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. These fees will help cover the cost of registra…
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COVID – Argentina Extended Period of Non-interven…
Importation of chinstraps, masks, gloves and infrared thermometers: non-intervention period is extended. It is reported that the ANMAT has d…
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New Version of the Australian Therapeutic Goods Adverti…
A new version of the Australian Therapeutic Goods Advertising Code (TGAC) has come into force from 1 January 2022. The TGAC sets out the req…
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Public Consultation Launched in China for “Measur…
On 26 November 2021, the State Administration for Market Regulation of China published the “Measures for the Administration of Interne…
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EAEU Centralised Medical Devices Regulation Enters in F…
As of 1st January 2022, the Eurasian Economic Union (EAEU), formed by Belarus, Kazakhstan, Russia, Armenia, and Kyrgyzstan, will enforce the…
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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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