IVD Regulatory Services · India
IVD Registration and Approval in India, From Classification to Market
Shen Clinical Services manages IVD registration in India under the Medical Devices Rules, 2017: risk classification, CDSCO import licences (Form MD-14/MD-15), state and central manufacturing licences, clinical performance evaluation for new IVDs, label compliance and Indian authorized agent support. Every in vitro diagnostic sold in India now needs this approval before it reaches the market.
Medical Devices Rules, 2017The legal framework for every IVD in India
Class A to DRisk-based classification decides your route
CDSCO Online PortalApplications, queries and approvals
Performance EvaluationRequired in India for new Class B, C and D IVDs
On this page
Is a Licence Mandatory?
Every IVD in India Now Needs a Licence
India moved IVDs from voluntary registration to full licensing in two stages. Importing or manufacturing an unlicensed IVD after these dates is not permitted.
| IVD risk class | Licensing mandatory from |
|---|---|
| Class A and B (low and low-moderate risk) | 1 October 2022 |
| Class C and D (moderate-high and high risk) | 1 October 2023 |
IVD Classification in India
IVD Classification in India: Your Risk Class Decides the Route
India classifies IVDs into four risk classes under Rule 4 of the Medical Devices Rules, 2017, using CDSCO’s published IVD classification list. If your product is not on the list, we request a risk classification from CDSCO through its online system before filing. For criteria and examples, see our IVD classification in India guide.
Manufacturing licences for Class A and B are issued by the State Licensing Authority; Class C and D by the Central Licensing Authority (CDSCO). All imports, whatever the class, are licensed by CDSCO.
| Class | Risk level | Manufacturing licence from | Import licence from |
|---|---|---|---|
| Class A | Low | State Licensing Authority | CDSCO (Central) |
| Class B | Low-moderate | State Licensing Authority | CDSCO (Central) |
| Class C | Moderate-high | CDSCO (Central) | CDSCO (Central) |
| Class D | High | CDSCO (Central) | CDSCO (Central) |
Licences and Forms
IVD Import Licence and Manufacturing Licence Forms
| Activity | Application form | Licence issued | Authority |
|---|---|---|---|
| Import licence (all classes) | MD-14 | MD-15 | CDSCO |
| Manufacturing licence, Class A and B | MD-3 | MD-5 | State Licensing Authority |
| Loan licence, Class A and B | MD-4 | MD-6 | State Licensing Authority |
| Manufacturing licence, Class C and D | MD-7 | MD-9 | CDSCO |
| Loan licence, Class C and D | MD-8 | MD-10 | CDSCO |
| Test licence to manufacture (evaluation, testing, training) | MD-12 | MD-13 | Licensing Authority |
| Test licence to import | MD-16 | MD-17 | CDSCO |
Up to 15 products can go in one import or manufacturing application; more can be added later by endorsement.
New IVDs
Launching a New IVD in India: Clinical Performance Evaluation
Required in India for Class B, C and D. A new IVD must undergo clinical performance evaluation in India, even if it is already approved in the EU, UK, USA, Canada, Australia or Japan. For Class A it is generally not required unless CDSCO asks for it. Our clinical site management team can run the evaluation at qualified Indian sites.
Three batches, three lots. Performance evaluation reports cover three independent batches made from different lots of key raw materials. An import application can be filed with one lot report and an undertaking for the other two; the licence then requires the remaining reports before sale.
Our Process
How We Take Your IVD Through CDSCO
STEP 01
Classification and Regulatory Strategy
We confirm your IVD’s risk class against CDSCO’s list, identify the right licence route for import or manufacture, and flag whether clinical performance evaluation is needed.
STEP 02
Dossier and Authorized Agent
Our regulatory writers compile the device master file, plant master file, ISO 13485 and free sale evidence, with overseas documents notarised or apostilled correctly. For foreign manufacturers we arrange an Indian authorized agent.
STEP 03
Submission and Query Management
We file on the CDSCO online portal and answer every query on time. Unanswered queries trigger reminders, and after the fourth reminder an application is treated as withdrawn.
STEP 04
IVD Labelling and Post-Approval
We check labels against Chapter VI of the Rules, including both expiry date and date of manufacture, and manage post-approval changes, software updates and licence retention.
Related Services
Complete IVD Regulatory Support
Import licence (MD-14/MD-15)
Manufacturing licence, Class A and B
Manufacturing licence, Class C and D
Loan licence
Test licence for import or manufacture
Clinical performance evaluation
Indian authorized agent support
Post-approval changes
Free Sale Certificate
ISO 13485 certification support
Classification requests to CDSCO
FAQs
IVD Registration in India: Frequently Asked Questions
Who issues IVD licences in India?
CDSCO, as the Central Licensing Authority, issues all import licences and manufacturing licences for Class C and D IVDs. State Licensing Authorities issue manufacturing licences for Class A and B IVDs.
Is there an “IVD certification” in India?
Not as a separate certificate. What people often call IVD certification in India is the licence issued under the Medical Devices Rules, 2017: an import licence (Form MD-15) or a manufacturing licence. ISO 13485 certification of your quality system is a separate requirement that supports the application.
Is clinical performance evaluation needed if my IVD is CE-marked or FDA-cleared?
Yes, for a new Class B, C or D IVD. CDSCO requires the evaluation to be done in India even when the product is approved in the EU, UK, USA, Canada, Australia or Japan.
Can a foreign manufacturer import an IVD without an Indian authorized agent?
No. The import licence application is made by an authorized agent in India who holds a manufacturing or wholesale licence under the Medical Devices Rules, 2017. More than one agent can apply for the same product.
What must an IVD label show in India?
Labels must comply with Chapter VI of the Medical Devices Rules, 2017, and must show both the shelf life or expiry date and the date of manufacture. India-specific stickers may be applied after import where the Rules allow it.
My IVD is not on CDSCO’s classification list. What now?
You can request a risk classification from CDSCO through its online system. We prepare the request and supporting justification before filing your licence application.
Resource Spotlight
Registering other medical devices too? See our medical device registration services and regulatory guidance and compliance, or our clinical site management services for running a performance evaluation study in India. No Indian entity yet? Our Indian Authorized Agent service holds your import licence.
Bring Your IVD to the Indian Market
New to India? Get an IVD regulatory assessment: your risk class, licence route, documents and evaluation needs.
Already filed? We take over stalled applications and respond to CDSCO queries.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: Medical Devices Rules, 2017; CDSCO IVD FAQs (2022) and Addendum No. 02 (13 March 2026); CDSCO In Vitro Diagnostics. General regulatory information, not legal advice.