RegDesk Regulatory Roundup -- Medical Device and Pharma

Nov 10, 2022

HSA Guidance on Importation of Unregistered Medical Devices for Exhibition: Specific Aspects

The new article describes in detail specific aspects related to the regulatory framework for the importation of medical devices intended to be used for exhibition purposes. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the...

FDA Guidance on Design Considerations for Clinical Outcome Studies: Controls

Nov 10, 2022

FDA

FDA Guidance on Design Considerations for Clinical Outcome Studies: Controls

The new article highlights the key points related to the controls in comparative clinical outcome studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a...

MDCG Guidance on Authorized Representatives: Key Responsibilities

Nov 10, 2022

EU MDR/IVDR

MDCG Guidance on Authorized Representatives: Key Responsibilities

The new article provides additional details regarding the aspects related to the responsibilities of authorized representatives. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical...

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Design Considerations

Nov 10, 2022

FDA

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Design Considerations

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the ethical considerations for clinical investigations with children involved. By virtue of the...

TGA Guidance on Clinical Evidence for Heart Valve Replacements: Overview

Nov 10, 2022

Australia and Oceania

TGA Guidance on Clinical Evidence for Heart Valve Replacements: Overview

The new article highlights the key points related to the clinical evidence for heart valve replacements using a prosthetic valve. Table of Contents The Therapeutic Good Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has...

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Intervention Assignment and Masking

Nov 10, 2022

FDA

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Intervention Assignment and Masking

The new article provides additional information regarding the intervention assignment (randomization) for clinical outcome studies and blinding (masking). Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...

RegDesk Regulatory Roundup

HSA Guidance on Importation of Unregistered Medical Devices for Exhibition: Specific Aspects

FDA Guidance on Design Considerations for Clinical Outcome Studies: Controls

MDCG Guidance on Authorized Representatives: Key Responsibilities

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Design Considerations

TGA Guidance on Clinical Evidence for Heart Valve Replacements: Overview

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Intervention Assignment and Masking

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