Regulatory Blog

The U.S. Food and Drug Administration (FDA) recently released (26 December 2024) draft guidance titled “ Protocol Deviations for Clinical...

The U.S. Food and Drug Administration (FDA) has updated and released its " Global Unique Device Identification Database (GUDID) "  final...

The South African Health Products Regulatory Authority (SAHPRA) has released two crucial guidelines to streamline adverse event reporting...

The Australian Regulatory Guidelines for Medical Devices (ARGMD) , issued by the Therapeutic Goods Administration (TGA), provide a...

The US Food and Drug Administration (USFDA)  has issued its final guidance on " Marketing Submission Recommendations for a Predetermined...

The US Food and Drug Administration (USFDA)  has released two insightful reports aimed at improving its internal practices and...

The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed guidance " Clinical Investigation s " on...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has launched (4th December 2024) a groundbreaking pilot scheme "...

In November 2024, the Medical Device Coordination Group (MDCG)  released " MDCG 2024-14 - Guidance on the implementation of the Master...

The USFDA Center for Devices and Radiological Health  has recently issued three key final guidance documents focusing on orthopedic...

The Medical Device Authority (MDA) in Malaysia has released a comprehensive guidance " Control of Obsolete and Discontinued Medical...

The 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review are pivotal initiatives by the USFDA to...

The Swissmedic guidance released an information sheet titled " Combined Studies: Clinical Investigations of Medical Devices, Medicinal...

The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...

Recently last week (30 October, 2024) the TGA released an updated reference material about the " Good Clinical Practice (GCP) Inspection...

The Medical Device Coordination Group (MDCG) has released guidance " Application of MDR requirements to ‘legacy devices’ and to devices...

The Medical Device Coordination Group (MDCG)  has released its updated guidance and templates for conformity assessment bodies, notified...

The Medical Device Coordination Group (MDCG)  has released a detailed guidance document titled " Qualification of In Vitro Diagnostic...

The Therapeutic Goods Administration (TGA) of Australia has released the latest version, v3.2, (on 13 September 2024) of the eCTD AU...

USFDA's Center for Devices and Radiological Health has released four final guidances about dental products, such as Dental Impression...