Automatic Class III Designation (De Novo) Summaries Evaluation
The Food and Drug Administration Modernization Act of 1997 (FDAMA) included the De Novo classification option as an alternate pathway for classifying novel medical devices that had been automatically classified as Class III after receiving a “not substantially equivalent” (NSE) […]
Read MoreMHRA Announces New Recognition Pathways To Promote Safe Access To Innovative Medications
The Medicines and Healthcare Products Regulatory Agency has stated that new regulatory recognition pathways for medications will be formed utilizing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States. The newly recognized channels provide the […]
Read MoreHealthcare: Making Use of Large Language Models
The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK provides a comprehensive framework for the regulation of SaMD. It includes considerations such as clinical evaluation, risk management, post-market surveillance, and more. As language models increasingly assist healthcare professionals […]
Read MoreEU MDR Certification are being extended for Transitional Periods, and the “sell-off” Criteria are being abandoned
The EU MDR Certification revised Regulations (EU) 2017/745 and (EU) 2017/746 on March 15, 2023, with respect to the transitional arrangements for certain medical devices and in vitro diagnostic medical devices. Under certain restrictions, the regulation establishes a staggered prolongation […]
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Abbott Trifecta Valves Potential Risk of Early Valve Degeneration by FDA
IntroductionThis article deals with the FDA is informing health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, which include the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which […]
Read MorePerformance and safety by Thailand medical device registration
This article deals with the Guidelines for Evaluating Requests for an Expert on Papers Demonstrating the Performance and Safety of Medical Devices by Thailand medical device registration. As mentioned in the Ministerial Regulation on Permits, it is appropriate to develop […]
Read MoreIndia – one of the top markets for GE Healthcare Intercontinental
The CEO of GE Healthcare has recently released a statement wherein he says that “India is among the top four out of the 60 countries and when it comes to technology, India is number one. GE recently launched a manufacturing […]
Read MoreUS FDA Authorizes Covid-19 Pill for High-Risk Adults
The US FDA has Authorized Merck’s Covid-19 pill for high risk adults after a similar pill by Pfizer was given a green light to rollout. Merck’s Covid -19 pill authorization provides an additional treatment option against the covid-19 virus which […]
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Operation Theatre as Medical Device India-Non Notified Medical Device Registration
Introduction – Operation Theatre as Medical Device India This article deals with the latest rules of Operation Theatre Products as a Medical Device India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization […]
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Unique Device Identification Number
What is a Unique Device Identification Number ? This blog deals with the Unique Identification Number and its guidelines. Singapore’s medical Device Market Regulator, the Health Science Authority (HSA), has published the final guidance for Unique Device identification (UDI) regulations […]
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