New Draft Regulations for IVD’s in India
This news article deals with the updates in the IVD regulations in India. They have come up with three drafts as follows – Draft Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) – The CDSCO has issued an […]
Read MoreA South Indian Based Company comes up with a Device to help Patients and Healthcare Professionals
A company from Chennai, claims to have developed a device which would be useful in filling the gap between COVID-19 patients and the medical staff treating COVID patients. Every patient does not have a dedicated attendant, to help curb the […]
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CDSCO’s updates for Test Kits and Drugs – Imports and Regulatory Approvals
The Indian CDSCO has issued several notices in order to keep up pace with requirements for the ongoing pandemic. They have implemented rules to fast track approvals and also bought in a new amendment on 11th February 2020, wherein apart […]
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IVD 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 […]
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IVD Classification System: Medical Device Rules, 2016
The Indian Ministry of Health and Family Welfare published a draft of Medical Device Rules, 2016 which are classified medium to high risk IVD devices under the new ivd classification system will require CDSCO (Central Drugs Standard Control Organization) registration certificate or […]
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Registration 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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