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Therapeutic Goods Medical Devices

Medical Devices

Italy Publishes News Regarding Q&A Document on Clinical Trials Facilitating Implementation of New Regulation
25th May 2023

The Italian Medicines Agency (AIFA) recently published news regarding a new document ‘Questions & Answers...

India Proposed Amendment To New Drugs And Clinical Trials Rules

Medical Devices

US FDA Announces Webinar to Discuss Decentralized Trial Draft Guidance
24th May 2023

US FDA recently released the draft guidance on decentralized clinical trials and has also scheduled...

Brain Nervous System Medical Device

Medical Devices

Philippines Published News Regarding Guidelines on Regulatory Reliance on the Conduct of Clinical Trials
22nd May 2023

The Food and Drug Administration (FDA Philippines) published news regarding guidelines about relying on the...

India Proposed Amendment To New Drugs And Clinical Trials Rules

Medical Devices

US FDA Proposed Draft Guidance on DCT for Drugs, Biological Products, and Devices
15th May 2023

The U.S. Food and Drug Administration (FDA) proposed draft guidance that contains its recommendations for...

Brain Nervous System Medical Device

Medical Devices

Taiwan Proposed to Use Electronic Manuals Replacing Chinese Manuals for Medical Devices
4th May 2023

Taiwan FDA published new law on Electronic Manuals replacing Chinese Manuals for Medical Devices.  ...

Therapeutic Goods Medical Devices

Medical Devices

US FDA: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
26th April 2023

US FDA proposed draft guidance titled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints...

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Medical Devices

US FDA Proposed Draft Guidance on Premarket Submissions for Orthopedic Non-Spinal Bone Plates, Screws, and Washers
24th April 2023

The U.S. Food and Drug Administration (FDA) proposed a draft guidance document that provides recommendations...

Brain Nervous System Medical Device

Medical Devices

Indonesia Ministry of Health Published News Regarding The Draft Health Law is a Solution for the Independence of Pharmaceuticals and Medical Devices
18th April 2023

Indonesia Ministry of Health published news regarding The Draft Health Law is a Solution for...

Therapeutic Goods Medical Devices

Medical Devices

FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices
10th April 2023

The final transition guidances provide recommendations and clarity for medical device manufacturers that may or...

Therapeutic Goods Medical Devices

Medical Devices

US FDA Issues Guidance of “Assembler’s Guide to Diagnostic X-Ray Equipment”
7th March 2023

This document supersedes Assembler’s guide to diagnostic x-ray equipment: responsibilities of assemblers, distributors, and dealers...

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