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Therapeutic Goods Medical Devices

Medical Devices

Rice-Sized Device Tests Brain Tumor’s Drug Responses During Surgery
6th October 2023

An NIH-funded team has developed a miniature device with the potential to predict the therapeutic...

Therapeutic Goods Medical Devices

Medical Devices

Brazil CONEP/CNS Publish Guidelines for Ethical Review Exemptions
1st September 2023

Brazilian National Commission on Ethics in Research – CONEP/CNS has published on its website a...

Therapeutic Goods Medical Devices

Medical Devices

US FDA Issues Revised Guidance on Qualification of Medical Device Development Tools
2nd August 2023

This final guidance supersedes Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers,...

Brain Nervous System Medical Device

Medical Devices

Health Canada Implements ICH Guideline on Nonclinical Biodistribution Considerations for Gene Therapy Products
1st August 2023

Health Canada has announced the implementation of guideline S12 on nonclinical biodistribution considerations for gene...

Therapeutic Goods Medical Devices

Medical Devices

Clinical trials of Medical Devices – Updates Regarding Ethics Committees and its composition by Italian Ministry of Health
20th July 2023

There have been so many changes in the clinical trial framework in Italy including four...

Decentralized Clinical Trials Guidance With Regask

Medical Devices

Indonesia Published News about Filling in Medical Device Dictionary Data
3rd July 2023

Ministry of Health (MOH) Indonesia published news about Filling in Medical Device Dictionary Data.  ...

Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling

Medical Devices

Taiwan Published Guidelines for Decentralized Measures for the Implementation of Drug Clinical Trials
26th June 2023

Taiwan Food and Drug Administration published Guidelines for Decentralized Measures for the Implementation of Drug...

Brain Nervous System Medical Device

Medical Devices

UK MHRA Published Guidance on Software as a Medical Device
20th June 2023

UK’s MHRA announced the Software and AI as a Medical Device Change Programme last year...

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...

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