FAQs 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 […]
Read MoreFAQ about Medical Device Registration in India
Introduction The process of medical device registration in India is regulated by the Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health and Family Welfare. All the medical devices must be registered with the CDSCO before […]
Read MoreExemption of Class A Non-Sterile/Non-Measuring Medical Devices from Licensing Regime
Introduction This Article deals with Class A Non-Sterile/Measuring Medical Devices which are now exempted from the MD-15 Requirement. The Ministry of Health and Family Welfare has released a new amendment to the Medical Devices Regulations (MDR) 2017. This includes provisions […]
Read MoreImport of Medical Devices into India
Introduction – Import of Medical Devices into India This article deals with the import of Medical Devices into India. The importation of Medical Devices in India is of prime importance for every manufacturer. In order to import into India, manufacturers have […]
Read MoreVoluntary Registration of Medical Devices in India
Introduction – Voluntary Registration of Medical Devices in India The Central Drugs Standard Control Organization (CDSCO) regulates Medical Devices in India. Until now, only the Notified Medical Devices have been regulated (there are 37 in this list) , mainly focusing […]
Read More