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CDSCO’s updates for Test Kits and Drugs – Imports and Regulatory Approvals

In-vitro Diagnostics

Regulation of all Licensed Class A and B medical Devices by October 2022

CDSCO’s updates for Test Kits and Drugs – Imports and Regulatory Approvals

The Indian CDSCO has issued several notices in order to

IVD Classification System: 2018

In India, In -Vitro Diagnostic kits/reagents are regulated under the

Medical Devices Rules, 2017: Classification of in vitro diagnostic (IVD’s)

Regulatory Approval and Classification of In Vitro Diagnostics India,2017: Updated Regulation for IVD Registration

The Regulatory Approval and Classification of In Vitro Diagnostics Rules

Classification of IVD in India, IVD Classification System India, New IVD Rules

IVD Classification System: Medical Device Rules, 2016

The Indian Ministry of Health and Family Welfare published a

IVD registration in India, IVD registration, IVDs in India, In-vitro Diagnostics India

Registration of In Vitro Diagnostics (IVD) in India

Introduction: In-Vitro Diagnostic (IVD) kits/reagents are regulated in India under

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