Indian Regulatory Framework
IVD Regulation in India - CDSCO Under MDR 2017
In-vitro diagnostic (IVD) devices in India are regulated under the Medical Devices Rules, 2017. The appropriate pathway depends on the device classification, intended purpose, whether it is new in India, and whether the activity is import, manufacture, testing, or clinical performance evaluation. A product-specific regulatory assessment should establish the applicable evidence and licensing route before filing.
Authority, Framework, and Classification
The Indian IVD market is regulated by the CDSCO under the oversight of the Drugs Controller General of India (DCGI), acting as the Central Licensing Authority (CLA). The CLA maintains jurisdiction over the import of all IVD classes, the manufacturing of high-risk (Class C and D) devices, and the approval of novel IVDs. Conversely, State Licensing Authorities (SLAs) handle manufacturing licenses for lower-risk (Class A and B) devices.
India IVD Risk-Based Classification
| Class | Risk Level | Examples | Authority |
|---|---|---|---|
| Class A | Low — general lab use | General chemistry reagents, non-diagnostic lab instruments | SLA |
| Class B | Low-Moderate | Pregnancy tests, blood glucose meters | SLA |
| Class C | Moderate-High | Cancer screening, genetic disease testing, HCV kits | CLA (CDSCO) |
| Class D | High public health risk | HIV diagnostics, blood group serology | CLA (CDSCO) |
Clinical Performance Evaluation: Assess Applicability Before Filing
Clinical performance evaluation and test-licence requirements are not interchangeable with ordinary import or manufacturing licensing. For an IVD that is new in India or otherwise requires additional evidence, the required study design, permissions, laboratories, and documentation must be confirmed from the current CDSCO route and the device facts. Existing CE or FDA documentation can inform a dossier, but does not by itself determine the Indian pathway.
Assessment questions
- Is the device classified and is its intended purpose clearly defined?
- Is the product new in India or subject to an additional permission route?
- What evidence, permissions, and test arrangements are applicable to this product?
Evidence planning
The evidence plan should be documented before samples are imported or studies begin:
- Performance claimDefine the intended use, analyte, user, and setting.
- Supporting dataMap analytical and clinical evidence to the applicable pathway.
- Submission routeConfirm the form, authority, and permissions before submission.
Official references for India IVD pathways
- Medical Devices Rules, 2017Use the rules and current notifications as the primary reference for classification, licensing, testing, and clinical-investigation obligations.
- CDSCO IVD FAQ and import guidanceCDSCO publications explain forms such as MD-14 and MD-15 and distinguish import, test-licence, and new-device considerations.
- Confirm current requirements before actingCDSCO guidance and forms can change. Validate the current route with the regulator’s latest publication before relying on a timeline or document checklist.
Primary regulatory sources
Our CDSCO Compliance Solutions
We navigate the intricacies of the Medical Devices Rules 2017 and coordinate local performance evaluations to guarantee your IVD product is market-ready in India.
SUGAM Portal Registration
We manage end-to-end import and manufacturing registrations via the CDSCO SUGAM portal, ensuring smooth dossier submission and tracking.
In-Country Performance Evaluation
We assess whether performance evaluation, testing permission, or other product-specific evidence is required for your CDSCO pathway.
Classification & Strategy
We determine the correct risk class for your IVD under Part II of the First Schedule and strategize your licensing pathway (CLA vs SLA).
Dossier Preparation
Comprehensive preparation of the applicable licensing dossier, forms, and supporting technical documentation under MDR 2017.
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