Regulatory Blog

When applying for inclusion in the Australian Register of Therapeutic Goods (ARTG), different classes of medical device require different...

This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket...

Drug Regulatory Authority of Pakistan (DRAP) has released draft guidelines that describe the requirements for commercial imports and...

The European Commission’s Medical Device Coordination Group (MDCG) released a document detailing how the newly implemented Medical Device...

This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support...

The Parliament of Finland has adopted a new Act on Clinical Trials on 8 October 2021. The Parliament also approved amendments to the...

This guidance summarises UK-MHRA’s approach to pharmacovigilance. The Guidance on pharmacovigilance procedures was Updated on 14 October...

On 8 May 2020, the Philippines Department of Health (DOH) entitled “Revised Guidelines on the Unified Licensing Requirements and...

European Commission’s Medical Devices Coordinating Group (MDCG) on 04-October-2021 issued guidance to support manufacturers classify...

The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting...

MHRA agency on 27 September 2021, provided the advice in an update to its guidance on "registering medical devices. MHRA has asked...

On 28-September, 2021 USFDA released draft guidance to assist sponsors in using an electronic template for submitting a premarket...

India’s Central Drugs Standard Control Organization (CDSCO) has published the steps that need to be followed by the manufacturers and...

On 28-September, 2021 USFDA released the guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To...

Updated Guideline on Classification Of Medical Devices and IVDs The aim of this guideline is to assist manufacturers, importers,...

Managing clinical trials during Coronavirus (COVID-19) On 8th September 2021, MHRA updated the guidance on How investigators and sponsors...

On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k). i.e.,...

The MDCG Guidance provides an overview of activities, requirements, auditing, surveillance and changes and minimum content of the...

This guidance document is intended to provide a general description of FDA Export Certification to industry and foreign governments. This...

Software-based Medical Devices are medical devices that incorporate or are software, including software as a medical device, or software...