The required transition to IVDR has shaken up the industry, and We at RAAJ takes a proactive approach to understand challenges and creating strategic plans to overcome them. We start with an impact assessment, align all of the necessary resources for a successful transition, identify the gaps in documentation, create a remediation plan, and execute it to help your products to reach the market.

The expansion of regulations to cover all diagnostic kits has now made it mandatory for registration of devices being sold in the country. The government has also given sufficient time to the Indian Manufacturers as well as Overseas suppliers to adopt such regulations and ensure that the Indian Consumers are assured safe and quality healthcare products.

Diagnostic Kits whether used In-vitro or In-vivo, either imported in India or manufactured in India for sale and use are now regulated under the New Medical Rules 2017.

The Medical Devices Rules 2017 has been drafted to ensure its as comprehensive as possible within present day industry limitations and is designed to be flexible enough to add or delete the list of categorized products which are to be published from time to time by Central Drugs Standard Control Organisation (CDSCO).

The rules came into force in January 2018 and the import, manufacturing, sale and distribution of existing In Vitro Diagnostic (IVD) kits/ reagents are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare under the regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945.

In line with risk-based classification of Global Harmonization task Force (GHTF), under the Medical Devices Rules 2017, IN-VITRO DIAGNOSTIC KITS in India are classified into Class A, B, C and D with the risk associated with a device increasing from Class A (Low Risk) to Class D (High Risk).