Disinfection and Antiseptic Practices, India
This article gives a detailed overview on Disinfection and Antiseptic Practices to be included in the Indian Pharmacopoeia to be included in Chapter IP 2026. It will be published officially from July 2024. A comprehensive cleaning and sanitization program is […]
Read MorePeriodic Safety Update Reports: CDSCO’s New Update
Periodic Safety Update Reports (PSURs) submission process has significantly undergone a transformation by the CDSCO, marking a pivotal shift in regulatory submissions in India. From 26th February 2024, the process for submitting Periodic Safety Update Reports (PSURs) transitions to a […]
Read MoreDrugs & Cosmetics Act and PWM: Effects on Medical Devices
The Drugs & Cosmetics Act of 1940, underpinning the regulatory framework for healthcare in India, has paved the way for remarkable advancements in medical diagnostics and treatment through the innovation and implementation of medical devices. India’s healthcare sector, expected to […]
Read MoreMedical Device Sales in India by Leveraging the GeM Portal
Medical Device Sales in India are facilitated through the The Government e-Marketplace (GeM), supported by India’s Commerce Ministry and the Association of Indian Medical Device Industry (AiMeD). It is a crucial link between over 300 AiMeD-associated medical device manufacturers and […]
Read MoreFAQs by CDSCO: Key Highlights and Updates
This article talks about the recently published FAQs by CDSCO and is structured under clear headings for better readability and understanding. In the dynamic landscape of medical device registration in India, the Central Drugs Standard Control Organization (CDSCO) plays a […]
Read MoreNational Single Window System (NSWS), India
National Single Window System (NSWS) – The Central Drugs Standard Control Organization (CDSCO) of India on January 01, 2024, published a notice talking about the release of a new portal called National Single Window System (NSWS). The National Single Window […]
Read MoreSoftware as Medical Device, India – Registration Requirements
Digital Health is fast emerging and is growing rapidly. New technologies such as telemedicines, Artificial Intelligence (AI) and Machine Learning (ML), Wearables for Glucose Monitoring, ECG etc are constantly evolving. Healthcare regulators across the world are devising regulations to help […]
Read MorePrice Capping in India by NPPA
The National Pharmaceutical Pricing Authority (NPPA) in India is a regulatory body responsible for controlling and regulating the prices of pharmaceuticals, including medical devices. It periodically identifies and notifies specific medical devices that come under price control, and fixes their […]
Read MoreCabinet approves the Policy for the Medical Device Sector
Introduction: Policy 2023 intends to support the Medical Device industry’s orderly expansion in order to satisfy the public health goals of access, affordability, quality, and innovation in India. The policy puts forth a plan for the industry’s rapid expansion in […]
Read MoreAbbott 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 […]
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