Regulatory Blog

The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...

Navigating regulatory requirements is crucial for pharmaceutical and medical device companies to ensure compliance and facilitate smooth...

The US Food and Drug Administration (USFDA) Center for Devices and Radiological Health recently released updated guidelines for dental...

WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...

The US Food and Drug Administration (FDA) issued a draft guidance for the industry yesterday titled “Addressing Misinformation About...

Today (08 July, 2024) the US Food and Drug Administration (FDA) has released guidance "Purpose and Content of Use-Related Risk Analyses...

The Therapeutic Goods Administration (TGA) has released updated guidance (03 July, 2024) "Regulatory Changes for Software-Based Medical...

The Medical Device Coordination Group recently updated the guidance"Standardisation for Medical Devices" include points on topics...

The swissmedic recently on 1st July, 2024 updated and shared two guidances "Guidance: Formal Requirements" and "Guidance: SwissPAR"....

The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...

The U.S. Food and Drug Administration, yesterday announced the release of a draft guidance, Essential Drug Delivery Outputs for Devices...

The European Commission Medical Device Coordination Group (MDCG) has issued a new guidance "Clinical Evaluation of Orphan Medical...

The Therapeutic Goods Administration (TGA) in Australia has issued guidance (21 June, 2024) on the "Regulatory Obligations for Exempt...

The European Commission has recently published two new guidance documents on Health Technology Assessment (HTA), dated June 13, 2024....

The USFDA's updated guidance (21 June, 2024) on "Considerations in Demonstrating Interchangeability With a Reference Product" provides...

Last Thursday (13 June 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Machine...

The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...

The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidance on (29 May, 2024) "Guidance for Industry on...

Medical Device Coordination Group (MDCG) released a second revision to its Surveillance Guidance for Medical Devices, aligning it with EU...

The European Medicines Agency (EMA) has recently released updated Q&A guidelines "New Guidance for Industry and Notified Bodies" that...