US FDA Proposed Draft Guidance on DCT for Drugs, Biolog…
The U.S. Food and Drug Administration (FDA) proposed draft guidance that contains its recommendations for implementing decentralized clinica…
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Taiwan Proposed to Use Electronic Manuals Replacing Chi…
Taiwan FDA published new law on Electronic Manuals replacing Chinese Manuals for Medical Devices. The Taiwan Medical Equipment and Cosmetics…
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US FDA: Patient-Focused Drug Development: Incorporating…
US FDA proposed draft guidance titled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for…
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US FDA Proposed Draft Guidance on Premarket Submissions…
The U.S. Food and Drug Administration (FDA) proposed a draft guidance document that provides recommendations to applicants, and submitters o…
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Indonesia Ministry of Health Published News Regarding T…
Indonesia Ministry of Health published news regarding The Draft Health Law is a Solution for the Independence of Pharmaceuticals and Medical…
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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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