Regulatory Pathway for In vitro diagnostics (IVD)

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2. Regulatory Pathway for In vitro diagnostics (IVD) Registration in India: IVDs have become integral components of modern healthcare across the globe to support the diagnosis, monitoring, and personalized treatment of diseases. IVDs are also in very high demand in India, where the IVD market was worth about USD 2.64 billion in 2023 and expected to grow at a CAGR of 7.17% from 2024 until 2030 by Scania Analytics. As a result, the demand, interest, and enthusiasm of foreign IVD manufacturers to register and enter the Indian market have peaked. However, before IVD devices can be introduced to India, manufacturers and importers must navigate a complex regulatory pathway. Moreover, understanding the registration process is crucial for entry into the Indian marketplace. This blog will help manufacturer and importers understand the IVD registration process in India, discussing the critical components necessary obtain a market launch in India. Keep reading for details.

3. What are IVD Devices? IVD Devices (in vitro diagnostics) are instruments employed to analyze biological samples (e.g., blood, tissue, urine, or other bodily fluids) outside of the human body. These tests are integral in providing valuable indications for the diagnosis of disease, monitoring a patient’s condition, quantifying certain substances, and identifying infections. More familiar examples of in vitro diagnostic devices are pregnancy test kits, COVID-19 test kits, blood glucose monitoring kits, immunoassays, and human genetic testing devices. Which Authority Regulates IVDs in India? The authority in charge of licensing and regulating IVDS in India is the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.

4. How IVDs are classified? IVDs are classified into four classes based on risk factors: Class A: Low risk IVDs. Eg. Clinical chemistry analyzer (not near patient testing). Class B: Low moderate risk IVDs. Eg. Pregnancy test strips, anti-nuclear antibody testing, urine test strips. Class C: Moderate high risk IVDs. Eg. Blood glucose self-testing system, Human leukocyte antigen (HLA) typing, prostate-specific antigen (PSA) screening. Class D: High risk IVDs. Eg. HIV blood donor screening, ABO/Rh(D) blood grouping analyser (near patient testing).

5. Central Licensing Authority’s Role in Regulating IVDs The Central Licensing Authority is responsible for: • Providing a license for the import of all classes of IVDs. • Regulating the manufacture of Class C and Class D (high risk) IVDs. • Providing the approval for clinical performance evaluation studies for new IVDs before they are allowed to be marketed in India. • Working with State Licensing Authorities to ensure that there is consistent oversight of IVDs post-marketing. Responsibilities of State Licensing Authority in Controlling IVDs According to the Medical Devices Rules, 2017, the responsibilities of the State Licensing Authority are: • To grant the licenses for the manufacture, sale or distribution of Class A or Class B (low risk) In Vitro Diagnostic medical devices in their state. • To regulate the sale, stocking, exhibition and distribution of IVDs of all classes in their states.

6. How to register an IVD in India? A manufacturer, importer or distributor can register an IVD in India by following these steps: • Identify the Class of IVD: Identify whether the device falls under Class A, B, C, or D based on its risk level. • Designate the Authorized Indian Rep(s): Authorized agent if the applicant is a foreign manufacturer. • Complete the Application Form: along with all supporting documents, for the developer or authorized agent on the SUGAM Portal: Manufacturer: Applies for the Manufacturing license on Form MD-3orMD-4--Class A & B apply on Form MD-3 or MD-4. Class C and D manufacturers, MD-7 or MD-8. More information about how to obtain a device manufacturing license can be read in our article, “5 Easy Steps To Obtain Your Medical Device Manufacturing License.” Importers: Can apply for not only the manufacture device license but the device Import license using Form MD-14.The process of obtaining a licensing device can be perused at our blog, “Medical Devices Registration for Import.” • Application for Review: The CDSCO will review the documents and may inspect overseas manufacturing. For example, review of importers data or evidence, while for manufacturers for India, will assign a State Licensing Authority (SLA)/ CLA a full site inspection process. • License Issuance: Subject to all requirements being fulfilled, if the CDSCO is satisfied, a manufacturing or import license will be issued that is valid for five years unless otherwise noted.

7. How Regulatory Solutions India Can Help You? If you have not registered your IVDs in India yet, RSI can assist you through the whole process. Having more than ten years in the medical device regulatory process, we have completed over 450 medical device registrations in all categories. We have worked with clients in over 20 countries and can assist with everything from submission to regulatory approval in an effort to facilitate the approval process and secure your place in the market quicker. Let RSI help with gathering your IVD registration in India, contact us today!

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