India Cdsco Medical Device Registration Service For IVD Device

Scope and evidence must be confirmed before any paid tests or filings.

CDSCO registration for an in-vitro diagnostic (IVD) is a sequence of applicant, classification, evidence and licensing decisions—not a single generic certificate. This execution guide covers diagnostic kits, reagents and related IVD instruments or software where they meet the regulated intended use.

Start with the intended use, specimen, user, manufacturer/site, origin and whether units will be sold or used only for evaluation. No service provider can promise an approval or prescribe one route without those facts.

Choose the correct IVD filing route

IVDs are risk-classified A–D under Part II of the First Schedule to the Medical Devices Rules, 2017. Import licensing for all classes is handled centrally; domestic manufacture follows a different division of responsibility. Verify the CDSCO classification list and request formal clarification when a product does not clearly fit.

Classification gate: CDSCO’s March 2026 FAQ addendum treats a product combining physiological parameters (for example ECG or blood pressure) with in-vitro testing as a medical device, not an IVD. Confirm the full intended functions before using an IVD-only filing route.

Actual activity	Application → outcome	Key gate
Commercial import of an IVD, classes A–D	Form MD-14 → import licence MD-15; Central Licensing Authority (CDSCO).	Indian authorised agent and import dossier; check models, intended uses and manufacturing sites in scope.
Domestic manufacture, class A/B	Form MD-3 → MD-5; state licensing authority (loan-licence route MD-4 → MD-6 if applicable).	Confirm IVD risk class and the actual licensed manufacturing premises.
Domestic manufacture, class C/D	Form MD-7 → MD-9; Central Licensing Authority (loan-licence route MD-8 → MD-10 if applicable).	Higher-risk manufacture: check site/QMS evidence and inspection pathway.
Manufacture in India solely for testing, evaluation or demonstration	Form MD-12 → test-manufacturing licence MD-13; confirm the competent authority and current submission channel.	Specify the controlled manufacturing site, test purpose and quantities; this is not a commercial manufacturing licence.
Import only for testing or evaluation, not commercial sale	Form MD-16 → test licence MD-17; check the currently designated online channel.	Define purpose, site, quantity, test plan and non-commercial use.
New IVD requiring additional permission	Where applicable, MD-24 → MD-25 (clinical performance evaluation) and MD-28 → MD-29 (new-IVD permission); CDSCO permits simultaneous MD-24 and MD-28 applications, while the necessary permissions must be obtained before the relevant commercial licence.	Do not substitute an ordinary MD-14 or manufacturing submission for a required new-IVD pathway.

Allocate responsibility before filing

An overseas manufacturer should not treat a consultant as the licence applicant by default. Identify the actual authorised Indian agent, its eligibility and the authority to represent the named manufacturing site.

Actor	What that actor must supply or control
Foreign legal/actual manufacturer	Device claims and variants, site identity, quality-system and performance data, labelling, technical file, change notifications.
Indian authorised agent / importer	Eligible licence, valid appointment/power of attorney, portal application, fees, replies, approved import scope and local vigilance coordination.
Regulatory filing coordinator	Gap register, document crosswalk, consistency review, portal drafting, query tracker and handover; does not replace the licence holder or regulator.

If the same IVD and the same legal and actual overseas manufacturing sites already have an Indian import licence through another agent, assess CDSCO’s “Subsequent Importer” online application. The second importer must obtain its own authorisation; it cannot rely on the first agent’s licence.

Build an IVD-specific evidence dossier

Use a document-to-field crosswalk, not a folder of certificates. Requirements depend on application type, current CDSCO checklists and whether an item is applicable. Separate the Plant Master File from the IVD Device Master File.

Dossier block	Evidence to assemble	Pre-submission consistency check
Applicant and site	Indian agent licence, appointment/POA, legal and actual site details; applicable overseas registration and free-sale evidence.	The agent, manufacturer, factory and product names agree across forms and certificates.
Device identification	Generic and brand names, model/catalogue list, variants, assay technology, intended purpose, specimen and target population.	Each item in the application matches the IFU, labels, certificates and product list.
Quality and manufacturing	Site/Plant Master File, quality-system documentation and relevant audits/certificates as required.	Certificate scope covers the correct legal and actual manufacturing sites.
IVD performance	Device Master File, analytical/clinical performance and risk controls, validation, stability, batch and evaluation data as applicable.	Claimed sensitivity, specificity, specimen type and shelf life are supported and consistent with the IFU.
Labelling and post-market	Labels, instructions for use (IFU), storage/transport claims, surveillance and complaint arrangements.	Shelf-life, warnings and model names are consistent throughout the dossier.
Application administration	Cover letter, prescribed legal form, applicable fee evidence, indexed uploads and signed declarations.	Correct application category, signatory, payment and readable attachments.

Submit and respond to the CDSCO IVD application

Operational hand-offs matter as much as technical evidence. Use these gates in order and keep a dated decision log:

Freeze the device scope: make a controlled list of each IVD, model, test, specimen, user, site and commercial or test-only purpose.
Check classification and new-IVD status against CDSCO material; record any unresolved interpretation before picking a form.
Confirm the Indian applicant and appointment documents; check that site and agency credentials cover the proposed scope.
Map the current official checklist to dossier evidence; assign each missing item to its owner and close contradictions.
Prepare the correct online form and upload set, verify the current portal route, authorised signatures and fee calculation before submission.
Track acknowledgement and regulator queries; route scientific questions to the manufacturer and maintain a versioned response package.
On approval, reconcile the issued licence/permission against the applied product, agent and site; release only authorised activities.

Prevent CDSCO IVD dossier queries and rejection

The following are pre-submission controls, not a prediction that CDSCO will reject a particular file. The 2026 CDSCO import guidance is a public-comment draft, not binding law.

Frequent failure mode	Control that prevents it
IVD claim or risk class unsupported	Reconcile intended use, specimen, technology, user and classification evidence.
Power of attorney, agent or signatory mismatch	Match names, sites, appointment, application and cover-letter signers; verify authentication rules.
Incomplete performance or stability trail	Index performance studies and reports by claimed analyte, specimen, model and batch; explain applicability gaps.
Model / IFU / free-sale certificate mismatch	Use a single item-by-item reconciliation sheet before uploading.
Testing route mistaken for commercial import	Keep MD-16/MD-17 evaluation-only quantities and commitments separate from MD-14/MD-15 commercial stock.

Retain the IVD licence and manage CDSCO post-approval changes

A granted permission is tied to its holder and approved scope. Treat changes and continuing obligations as a controlled regulatory workstream, not as an automatic extension to all future variants.

Retain the licence according to current rules, including applicable retention-fee obligations; never assume that “perpetual” means maintenance-free.
For an applicable import licence, track the prescribed five-year retention-fee cycle for the base licence and its endorsements together. An endorsement issued later does not start a fresh five-year cycle.
Assess changes to intended use, models, manufacturing site, quality system, IFU or agent before implementation; check endorsement or post-approval-change steps.
For an already approved IVD, the March 2026 CDSCO FAQ addendum calls for a post-approval-change (PAC) application when approved software versions or device accessories/components change. Verify the approved change before implementation.
Operate complaint, adverse-event, field-action and recall processes appropriate to the product and applicable requirements.
Keep batch, distribution and performance records accessible for authority queries and market surveillance.
Reconfirm official checklists and portal notices before subsequent submissions; 2026 IVD classification requests are available through the CDSCO online system.

What the filing service does—and does not decide

A useful filing mandate yields a route memo, applicant/site map, dossier gap matrix, application-ready documents, submission record, query log and a post-approval obligation register. It cannot guarantee licensing, waive regulator discretion or replace missing studies.

For broader device filing see general CDSCO medical-device registration; for pre-filing classification and regulatory strategy see IVD classification and regulatory advisory. This page focuses on executing a defined IVD application, not mapping every medical-device regime.

IVD filing: questions that change the answer

Can a foreign IVD manufacturer apply without an Indian agent?

For commercial import, the CDSCO route uses an eligible authorised Indian agent/applicant. Confirm its licence and authority to act before preparing MD-14.

Does an MD-17 test licence allow commercial sale?

No. The MD-16/MD-17 route is for specified test, evaluation or similar limited purposes; commercial import requires the applicable separate authorisation.

Does an overseas CE certificate replace the Indian IVD dossier?

No. Overseas certificates may support designated evidence fields but do not replace the applicable Indian form, device file, scope and CDSCO decision.

What if the IVD is novel or has no established predicate?

Check whether new-IVD clinical performance evaluation and MD-28/MD-29 permission are triggered before the normal commercial licence. A product-level assessment is necessary.

Can a new variant be shipped under an existing MD-15?

Only when the exact variant and related site/indication fall within the approved scope. Otherwise assess endorsement or post-approval change before shipment.

Can a second Indian importer use another agent’s existing import licence?

No. Where the IVD and both legal and actual overseas manufacturing sites are the same, assess a separate “Subsequent Importer” application through the CDSCO medical-device online portal. Otherwise reassess the ordinary import application.

Official regulatory references

Procedure and portal screens may change. Check current legally operative rules, CDSCO notices and the application-specific checklist before filing.