What is an IVD license?

It is a mandatory registration with the CDSCO to manufacture or import diagnostic kits and reagents in India.

What is a Performance Evaluation Report (PER)?

It is a report from a government-notified lab that verifies the accuracy and reliability of the IVD kit.

Do Class A IVDs need a license?

Yes, even low-risk IVDs need to be registered on the SUGAM portal, though they don't require a prior audit.

Is COVID-19 kit registration still required?

Yes, all diagnostic kits for infectious diseases fall under Class C or D and require strict CDSCO approval.

What is the role of the National Institute of Biologicals (NIB)?

NIB is one of the premier labs notified by CDSCO for the performance evaluation of various IVD kits.

How long is the IVD license valid?

The license is permanent, subject to the payment of license retention fees every 5 years.

Can I import IVD reagents without a license?

No, importing reagents for diagnostic use without a CDSCO license is a violation of the Medical Device Rules.

How long does the process take?

Depending on the class and testing time, it usually takes 4 to 9 months.

Service

IVD License India

Expert assistance for IVD licenses. We help with registration of diagnostic kits, reagents, and lab equipment. Compliance with Medical Device Rules 2017.

Regulating Diagnostic Precision

Expert assistance for IVD licenses. We help with registration of diagnostic kits, reagents, and lab equipment. Compliance with Medical Device Rules 2017.

Obtain the mandatory CDSCO license for manufacturing or importing In-Vitro Diagnostic (IVD) kits, reagents, and instruments in India.

Precision in diagnostics. Get your IVD kits, reagents, and equipment licensed by the CDSCO to ensure accuracy and legal compliance in Indian labs.

In-Vitro Diagnostics (IVDs) are tests done on samples such as blood or tissue that have been taken from the human body. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. Because of their critical role in clinical decision-making, they are strictly regulated by the CDSCO.

Under the Medical Devices Rules, 2017, IVDs are treated as a sub-category of medical devices but have their own specific classification and performance evaluation criteria. Whether you are manufacturing a simple pregnancy test kit or a complex molecular diagnostic platform, a valid CDSCO license is mandatory.

QuickTaxperts provides specialized regulatory support for diagnostic companies, managing the classification, performance evaluation coordination, and the complex TECHNICAL filing process on the SUGAM portal.

Category: Health & Medical
Covers specialized items like rapid kits, ELISA, PCR reagents, and analyzers.
Requires validation of the 'Analytical Sensitivity' and 'Specificity' of the kit.
Mandatory compliance with ISO 13485 (QMS) for manufacturers.
Enables participation in large-scale government health screening tenders.
Mandatory for all diagnostic kits (COVID, HIV, Pregnancy, etc.)
Registration under the Medical Devices Rules, 2017
Covers reagents, calibrators, and control materials
Requires performance evaluation by recognized labs

IVD Risk Classification

Determining the sensitivity and risk level.

Class A: Low Risk. (e.g., General lab reagents, specimen containers).
Class B: Low to Moderate Risk. (e.g., Pregnancy kits, glucose tests).
Class C: Moderate to High Risk. (e.g., Cancer markers, blood grouping reagents).
Class D: High Risk. (e.g., HIV, Hepatitis, or other transmissible disease tests).

Documents required

Document requirements vary by entity type, state, premises, and authority. These are the usual groups we verify before submission.

IVD Checklist: ISO 13485 Certificate for the manufacturing unit.; Device Master File (DMF) with technical and stability data.; Performance Evaluation Report (PER) from a recognized lab.; IFU (Instructions for Use) and Pack Insert drafts.; Free Sale Certificate (for imported IVDs).; Clinical performance data (for high-risk Class D IVDs).; Site Master File of the manufacturing location.

Process and timeline

Classification: Identifying the correct class based on the intended use and risk.
Performance Evaluation: Getting the kit tested at a CDSCO-notified laboratory (e.g., NIB or CMC).
Online Filing: Submitting the application for Manufacturing (Form MD-7) or Import (Form MD-14).
Technical Review: Responding to queries regarding the kit's sensitivity, specificity, and shelf-life.
License Grant: Receiving the final CDSCO license for the IVD products.

Expert review

IVD License India content is reviewed by QuickTaxperts Diagnostic Regulatory Team, IVD Compliance Specialists.

Checklist-led review
Document pre-verification
Authority-specific next steps

Frequently asked questions

These quick answers cover common planning questions before you request a checklist or quote.

What is an IVD license?: It is a mandatory registration with the CDSCO to manufacture or import diagnostic kits and reagents in India.
What is a Performance Evaluation Report (PER)?: It is a report from a government-notified lab that verifies the accuracy and reliability of the IVD kit.
Do Class A IVDs need a license?: Yes, even low-risk IVDs need to be registered on the SUGAM portal, though they don't require a prior audit.
Is COVID-19 kit registration still required?: Yes, all diagnostic kits for infectious diseases fall under Class C or D and require strict CDSCO approval.
What is the role of the National Institute of Biologicals (NIB)?: NIB is one of the premier labs notified by CDSCO for the performance evaluation of various IVD kits.
How long is the IVD license valid?: The license is permanent, subject to the payment of license retention fees every 5 years.
Can I import IVD reagents without a license?: No, importing reagents for diagnostic use without a CDSCO license is a violation of the Medical Device Rules.
How long does the process take?: Depending on the class and testing time, it usually takes 4 to 9 months.