A diagnostic company may have its product ready, foreign approvals in place and an Indian distributor appointed, but still be unable to proceed correctly in India because one basic question remains unanswered: what is the CDSCO regulatory route for the IVD?
For in-vitro diagnostic medical devices, the answer depends on the product’s intended use, CDSCO risk classification, whether it is imported or manufactured in India, and whether it is an existing or new IVD.
India regulates IVD kits, reagents, instruments, analyzers and qualifying software under the Medical Devices Rules, 2017. IVDs are classified as Class A, B, C or D, and different licensing authorities and application forms apply to different categories.
For businesses, therefore, CDSCO registration for in-vitro diagnostic medical devices should begin with product classification—not portal filing.
An IVD is generally intended to examine specimens derived from the human or animal body outside the body for diagnostic purposes. CDSCO confirms that IVD kits and reagents are regulated under the Medical Devices Rules, 2017. Instruments, analyzers and software intended specifically for in-vitro diagnostic purposes can also fall within the regulatory framework.
Typical regulated products may include diagnostic reagents, assay kits, analyzers, specimen receptacles and diagnostic software, depending on their intended purpose and classification.
However, a laboratory product is not automatically an IVD merely because it is used in a laboratory. CDSCO’s FAQ states that products intended only for research use, quality-control applications, food or water testing and similar non-diagnostic uses may fall outside MDR 2017 where they are not intended for diagnosis in humans or animals.
Before preparing an application, confirm:
| Question | Why it matters |
| Is the product intended to examine a human or animal specimen? | Helps establish IVD applicability |
| What exactly does the product detect or measure? | Determines intended use |
| Is the result used for diagnosis, screening, monitoring or patient management? | Influences classification |
| Is it labelled only for Research Use Only? | May change regulatory applicability |
| Is the device already present in CDSCO’s classification list? | Helps confirm the recognised risk class |
| Is an equivalent/predicate IVD already approved in India? | Important for the new-IVD pathway |
The intended-use statement should be finalised carefully because CDSCO classification is based on intended use and the parameters in Part II of the First Schedule.
Rule 4 of the Medical Devices Rules, 2017 provides four risk classes for IVDs:
| Class | Risk level |
| Class A | Low risk |
| Class B | Low-moderate risk |
| Class C | Moderate-high risk |
| Class D | High risk |
The Central Licensing Authority is responsible for classification based on the intended use and First Schedule criteria.
The classification rules are more detailed than simply deciding whether a product is a “diagnostic kit.” For example, certain blood-grouping and tissue-typing IVDs may be Class C or D, many self-testing devices fall within Class C subject to specified exceptions, and certain near-patient tests are Class C. Other IVDs may fall into Classes A or B depending on their function and risk.
This has become particularly important for new diagnostic technologies.
CDSCO introduced a dedicated Risk Classification Module for IVDs from 2 February 2026. An applicant whose device is not listed in CDSCO’s published IVD classification list can submit a classification request through the CDSCO Online System for Medical Devices. The announced document requirements include the intended use, indication, technology, device principle, components, IFU/package insert, labels and available overseas regulatory status.
This makes classification a practical pre-application step rather than something that should be guessed from a similar product.
There is no single application called an “IVD registration form” that applies to every business.
| Business activity | Normal regulatory route |
| Import of a licensed IVD | MD-14 application → MD-15 import licence |
| Manufacture of Class A requiring licence / Class B IVD | MD-3 → MD-5 |
| Manufacture of Class C or D IVD | MD-7 → MD-9 |
| Class A non-sterile/non-measuring device | Online registration route under Chapter IIIB, where applicable |
| Import/manufacture of a new IVD | MD-28 → MD-29 before commercial licence |
| Clinical performance evaluation of a new IVD | MD-24 → MD-25 |
| Sale/stock/distribution registration | MD-41 → MD-42, where applicable |
The authority also changes by activity. CDSCO’s Central Licensing Authority handles imports of all classes, manufacture of Classes C and D and approval/clinical performance evaluation of new IVDs. The State Licensing Authority handles manufacturing of Classes A and B and sale/distribution matters.
For normal commercial import, Rule 34 provides for an application in Form MD-14 by an eligible Indian authorised agent. After regulatory review, the Central Licensing Authority may grant the import licence in Form MD-15.
The authorised agent must satisfy the eligibility requirements under the Rules. Depending on the situation, this may involve an appropriate manufacturing, wholesale or MD-42 registration credential.
| Foreign manufacturer | Indian authorised agent |
| Manufacturing-site information | Applicant and Indian regulatory coordination |
| Quality-system documents | Eligible Indian licence/registration |
| Device Master File | MD-14 submission |
| Product regulatory status | Government-fee documentation |
| Free Sale Certificate, where applicable | Query responses |
| Technical and performance evidence | India-specific label/document review |
| Power of Attorney execution | Post-approval coordination |
A common practical problem is inconsistency across these records. Product names, model numbers, manufacturing-site addresses and intended-use statements should describe the same device throughout the dossier.
For domestic manufacturers, classification determines the licensing authority.
For a Class A device requiring a licence and Class B IVD, Rule 20 requires application to the State Licensing Authority in Form MD-3 for the normal manufacturing licence route. The licence is issued in Form MD-5 when the application is approved.
For Class C and Class D IVDs, Rule 21 provides for application in Form MD-7 to the Central Licensing Authority.
CDSCO’s IVD FAQ further explains that manufacturing-site scrutiny varies by risk class: Class B manufacturing involves an audit by a registered Notified Body, while Class C and D manufacturing sites are subject to inspection under the applicable rules.
Class A non-sterile and non-measuring medical devices follow a separate registration framework under Chapter IIIB. Manufacturers upload prescribed information on the Online System for Medical Devices and a registration number is generated after the required information is furnished. The Rules also contain a corresponding registration mechanism for their import.
Whether a particular IVD qualifies for this route should be established from its actual classification, measuring function, sterility status and intended use rather than assumed from the fact that it is Class A.
A product may need an additional regulatory stage if it qualifies as a new in-vitro diagnostic medical device.
Rule 64 provides for an application in Form MD-28 for permission to import or manufacture a new IVD. If approved, permission is granted in Form MD-29. A commercial manufacturing or import licence for such a product cannot simply bypass this prior permission requirement.
Where clinical performance evaluation is required, the application is made in Form MD-24, and permission is granted in Form MD-25.
This distinction is important for businesses introducing newer technologies, novel biomarkers, new intended uses or diagnostic products for which an appropriate predicate cannot be established in India.
The exact document set depends on the application pathway, class, product and whether the applicant is importing or manufacturing.
A typical dossier may involve:
The Fourth Schedule requires extensive IVD-specific technical documentation, including device description, intended use, configurations, software information where applicable, Essential Principles conformity, risk analysis and supporting performance information.
The Fifth Schedule establishes Quality Management System requirements applicable to manufacturers of IVD medical devices.
Before filing, compare the following fields across every major regulatory document:
Product name → Generic name → Brand → Model → Intended use → Manufacturer name → Manufacturing-site address → Shelf life → Risk class
One inconsistency can create questions about whether the documents relate to the same device.
Government fees are prescribed in the Second Schedule of the Medical Devices Rules, 2017.
| Application | Site fee | Distinct device fee |
| Class A requiring licence / Class B | ₹5,000 | ₹500 |
| Class C / Class D | ₹50,000 | ₹1,000 |
| IVD class | Overseas manufacturing-site fee | Each distinct IVD |
| Class A requiring import licence / Class B | US$1,000 | US$10 |
| Class C / Class D | US$3,000 | US$500 |
An overseas manufacturing-site inspection, where undertaken under Rule 35, carries a prescribed fee of US$6,000. The Second Schedule separately specifies US$100 per distinct device for an import test licence and ₹25,000 for permission to import or manufacture a new IVD under Rule 64.
These are government fees, not Green Permits professional charges. Testing, document authentication, laboratory work, translation and consultancy can create separate project costs.
Determine whether the product is actually intended for in-vitro diagnosis rather than research, industrial testing or another non-IVD purpose.
The intended use influences classification and should align across the IFU, labels, Device Master File and regulatory application.
Check CDSCO’s published classification lists. For an unlisted product, consider the CDSCO risk-classification mechanism introduced in 2026.
Determine whether the applicant is a domestic manufacturer, Indian authorised agent, importer or seller/distributor.
If a suitable predicate is unavailable and the product falls within the new-IVD framework, the MD-28/MD-29 pathway may become a prerequisite.
CDSCO’s IVD FAQ describes performance-evaluation requirements for relevant IVD categories and test batches. Requirements should be mapped product by product rather than applying one generic test package to every diagnostic device.
Complete applicant documents, PMF/DMF information, risk management, performance evidence, labels, IFU and required declarations.
Submit through the identified government online system using the correct form and fee.
Responses should reconcile the entire dossier rather than answering the regulator’s question in isolation.
Commercial import or manufacturing should proceed under the applicable valid licence or registration and according to its approved scope.
Two products that appear technically similar can fall into different classes because their intended clinical purpose creates a different level of risk.
The intended-use statement on the label should not contradict the IFU, Free Sale Certificate, Device Master File or classification rationale.
RUO and industrial/laboratory products without a diagnostic intended use need to be evaluated separately. CDSCO expressly distinguishes several non-diagnostic products from regulated IVDs.
Performance data can become particularly important for Class B, C and D IVDs and for new products. CDSCO’s official FAQ discusses evaluation using multiple batches in relevant circumstances.
MD-14/MD-15 and MD-28/MD-29 perform different regulatory functions. A new IVD may require the prior permission pathway in addition to the eventual commercial licence.
Your application is substantially more prepared when you can answer yes to these questions:
If several answers are “no,” filing immediately may simply transfer unresolved problems into the regulatory review process.
An import licence granted under Rule 36 remains valid unless cancelled or surrendered, subject to payment of the prescribed retention fee after each five-year period.
Major changes may require regulatory notification or prior approval depending on their nature. CDSCO identifies matters such as changes affecting intended use, design, certain manufacturing details, shelf life and specified manufacturer or authorised-agent information among the areas requiring regulatory control.
Therefore, compliance does not end when the licence is issued. Businesses should maintain regulatory control over product changes, labels, authorised-agent arrangements, manufacturing-site details and technical documentation.
IVD kits and reagents intended for diagnostic purposes are regulated under the Medical Devices Rules, 2017. Products not intended for diagnosis, such as qualifying Research Use Only or industrial testing products, need separate applicability assessment.
The Central Licensing Authority handles import of all classes of IVD medical devices.
For the normal commercial import-licence pathway, the authorised agent applies in Form MD-14 and the approved licence is Form MD-15.
Class A devices requiring a manufacturing licence and Class B IVDs are generally handled by the applicable State Licensing Authority. Class C and D manufacturing is handled by the Central Licensing Authority.
CDSCO introduced an online IVD risk-classification module effective 2 February 2026 for applicants seeking classification of devices that do not appear in the published lists.
Where the product qualifies as a new IVD under MDR 2017, an application can be required in Form MD-28, with permission granted in Form MD-29.
For an IVD company, the most useful regulatory work often happens before the application is filed.
Green Permits can assist manufacturers, importers and overseas IVD companies with:
For businesses planning CDSCO registration for in-vitro diagnostic medical devices in India, the first step should be to establish the product, intended use, class and applicant route before spending time preparing the complete dossier.
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