TUV SUD Inspects IVD Medical Devices’ Cyber Security
The growing digital connectivity of medical infrastructure is resulting in complicated systems with a plethora of diverse interfaces that are potentially vulnerable to assault. The IVD requires producers to provide proof of cyber security before releasing their products to the […]
Read MoreFDA Registration – SARS-CoV-2 Molecular Diagnostic Tests
This Article Deals about FDA Registration for Diagnostic Kits. The approved SARS-CoV-2 molecular diagnostics was published on February 21, 2023 by the Food and Drug Administration, USA. These EUAs have been granted with specific authorization requirements for the manufacturer and accredited […]
Read MoreThe CDSCO extends its clearance to Import Drugs with less than 60% Shelf Life upto October
The Indian FDA (CDSCO) has extended the time frame of importation of Drugs with less than 60% shelf life by three months. On April 17, 2020, the DCGI had received notices from the Medical Device Manufacturer’s informing them that due […]
Read MoreIVD Classification System: 2018
In India, In -Vitro Diagnostic kits/reagents are regulated under the provisions of the Medical Device Rules, 2017. IVD’s are defined as substances intended to be used outside human or animal bodies for the diagnosis of any disease or disorder in […]
Read MoreRegulatory Approval and Classification of In Vitro Diagnostics India,2017: Updated Regulation for IVD Registration
The Regulatory Approval and Classification of In Vitro Diagnostics Rules 2017, was updated by Ministry of Health and Family Welfare, which will come into force on January 1, 2018. This will replace the country’s Drugs and Cosmetics Act for creating […]
Read MoreRegistration of In Vitro Diagnostics (IVD) in India
Introduction In-Vitro Diagnostic (IVD) kits/reagents are regulated in India under the regulatory provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. In-Vitro Diagnostic Products are those substances that are intended to be used for or in the use […]
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