Registration of In Vitro Diagnostics (IVD) in India

India’s IVD market is evolving rapidly, and so is its regulatory environment. For manufacturers and importers, staying compliant with the Medical Devices Rules (MDR-2017) is the single most important factor for a successful launch. From classification to the final CDSCO import license, this guide simplifies the complex regulatory hurdles into a straightforward path to market entry.

WHAT IS AN IVD?

In India, In Vitro Diagnostic (IVD) devices are regulated as drugs under Section 3(b)(i) and 3(b)(iv) of the Drugs and Cosmetics Act, 1940. This regulation came before the introduction of the Medical Devices Rules, 2017, which provided a specific regulatory pathway for IVDs and medical devices. The introduction of these rules allowed IVDs to be categorized based on their risk levels, which must be determined before they can be registered for marketing or import. There are two main regulatory pathways for IVDs registering IVDs in India: with a predicate device, where the device is similar to an already approved product, and without a predicate device, for new devices without an equivalent in the market. The process for new devices requires more extensive clinical performance data and testing, while products similar to existing ones may have a simpler approval process. Understanding these pathways is important for obtaining the necessary import license in India and ensuring regulatory compliance.

REGULATORY PATHWAYS FOR IVDS IN INDIA

Depending on your business model (Import vs. Manufacturing) and the risk class of your device, you will interact with different authorities:

Central Licensing Authority (CLA): The Drugs Controller General of India (DCGI) oversees the import of all IVD classes and the manufacturing of Class C and D devices. They also handle clinical performance evaluations.
State Licensing Authority (SLA): Responsible for regulating the manufacture of Class A and B devices within their respective states, as well as the sale and distribution of all classes.

FORMS FOR PREDICATE DEVICES AND NON‑PREDICATE DEVICE (IVD) UNDER CDSCO

1. Predicate Device

When submitting a predicate device application to the Central Drugs Standard Control Organization (CDSCO) for IVD devices, you typically need to use different forms compared to those for non-predicate devices. If you have a predicate device (i.e., an existing device with similar intended use, design, and material approved in India), you would typically use the following forms:

MD‑14 – Import License Application for IVDs based on a predicate device. This is generally used when you are importing a device that has a predicate approved in India. You provide the necessary documentation comparing your IVD device with the predicate, such as performance data or technical specifications.
MD‑15 – Manufacturing License Application for IVDs based on a predicate device.If you plan to manufacture the device in India, you will use this form. Again, you would submit data that shows substantial equivalence to the predicate device.

2. Non‑Predicate Device

Since your device can’t be compared to any Indian‑approved device:

You may need to demonstrate clinical performance / safety / efficacy in India:

In some cases, clinical investigation (performance evaluation) may be required.

You submit different forms (depending on the context):

For a non‑predicate IVD, application and permission may involve specific forms such as MD‑26/MD‑27 (approval for devices without predicate), or for new IVDs MD‑28/MD‑29.

3. If your device is already approved in reference countries (e.g., USA, EU, Australia, Canada, Japan) for more than 2 years, you may avoid local clinical investigation, but this is considered on a case‑by‑case basis.

4. Non‑predicate devices often go through review by a Subject Expert Committee (SEC), and may require additional clinical data or an overall stricter evaluation.

THE REGISTRATION PATHWAY FOR IVDs IMPORTERS

Foreign manufacturers cannot apply directly to the Central Drugs Standard Control Organization (CDSCO). The process is centralized through an Authorized Indian Representative (AIR).

Step 1: Appointment of an Authorized Indian Representative (AIR)

The AIR must be an Indian legal entity holding a valid wholesale license (Forms 20B/21B). They act as the primary liaison between the foreign manufacturer and the CDSCO, assuming legal responsibility for the products sold in India.

Step 2: SUGAM Portal Registration

All applications must be submitted digitally via the SUGAM portal. The AIR registers the foreign manufacturing site and uploads preliminary documents, including corporate address proof and a Power of Attorney (PoA) authenticated by the Indian Embassy or through Apostille.

Step 3: Technical Dossier Preparation (DMF & PMF)

The core of the application lies in two master files:

Plant Master File (PMF): Detailed information about the manufacturing facility, its quality management system (ISO 13485), organizational structure, and production processes.
Device Master File (DMF): This contains technical specifications, intended use, design data, risk management files, and performance evaluation reports.

Step 4: Submission of Form MD-14

The formal application for an import license is filed under Form MD-14. This involves paying the requisite government fees, which are categorized by site and per-product.

Step 5: Performance Evaluation and Lab Testing

For high-risk IVDs (especially Class C and D), the CDSCO may require samples to be tested at a government-approved laboratory, such as the National Institute of Biologicals (NIB). This ensures that the device’s sensitivity and specificity meet Indian standards.

Step 6: Grant of License (MD-15)

Upon successful review and testing, the CLA issues the Form MD-15, the official import license. Under current rules, these licenses are valid in perpetuity, provided that a retention fee is paid every five years.

5. Manufacturing Licenses for Domestic Players

For companies manufacturing IVDs within India, the forms differ by class:

Class A & B: Application is filed via Form MD-3, and the license is granted in Form MD-5.
Class C & D: Application is filed via Form MD-7, and the license is granted in Form MD-9.

Domestic manufacturing sites for Class B, C, and D are subject to mandatory audits by a Notified Body or CDSCO inspectors to verify Quality Management System (QMS) compliance.

6. Critical Technical Requirements: Stability and Performance

The CDSCO places heavy emphasis on the stability of IVD reagents. Manufacturers must provide:

Real-time Stability Data: Evidence of the product’s shelf life under recommended storage conditions.
Accelerated Stability Data: Used to predict shelf life faster under stressful conditions.
Open-vial Stability: Essential for multi-use reagents to ensure they remain effective once the seal is broken.

Performance parameters like Sensitivity, Specificity, Potency, and Precision must be clearly documented in the DMF to demonstrate clinical utility.

7. Labeling Compliance: Rule 44

Under the MDR 2017, labeling is not just an aesthetic requirement but a legal one. Rule 44 mandates that IVD labels include:

The name of the IVD and its intended use.
The manufacturer and importer’s full address.
Batch/Lot number, manufacturing date, and expiry date.
Storage conditions and temperature ranges.
The statement “For In-Vitro Diagnostic Use.”
The Unique Device Identification (UDI) (as per phased implementation) – As per Rule 56 of the Medical Device Rules, 2017, effective from January 1, 2022, it is mandatory for all In-Vitro Diagnostic (IVD) devices to be labeled with a Unique Device Identification (UDI).

REGULATORY TIMELINE AND FEES

The timeline for the approval process related to various applications for medical devices and in-vitro diagnostic (IVD) products.

Step	Timeline	Details
Issuance of Import License	9 months from the application date	Timeline is suspended if a query is raised by CDSCO.
Receiving Query from CDSCO	3-4 months from the application date	CDSCO may raise multiple rounds of queries.
Time to Reply to Queries	45 days from receipt of queries	Applicants should respond within this period.
If Delay in Responding to Queries	No specific limit for delay	An intimation can be sent to CDSCO with reasons for delay.
Processing of Query Response by CDSCO	No prescribed timeline	The timeline for grant of import license is still 9 months from application.
Appealing Rejection to Central Government	45 days from the rejection date	Appeal must be filed within 45 days of rejection.
Central Government Response to Appeal	90 days from the date of appeal	The Government must respond within 90 days after the appeal.
Import License Validity (Form MD-15)	Valid in perpetuity unless cancelled or surrendered	Subject to payment of retention fee.
Retention Fee Payment	Every 5 years	Retention fee is paid every 5 years to keep the license valid.
Late Fee for Retention Fee Payment	2% per month or part of the month for up to 90 days	Late fee applies if the retention fee is not paid within the prescribed time.
License Cancellation for Non-Payment	After 90 days of non-payment of retention fee	Non-payment for 90 days will result in the cancellation of the license.

Fee structure for import licenses for IVDs based on the document and processes: IVD Classification System: 2018

HERE ARE THE KEY POINTS TO REMEMBER REGISTRATION PATHWAYS FOR IVDS:

To maintain the validity of the license, the manufacturer/importer must renew it every 5 years and ensure the required fee is paid within 90 days of the due date.
The license will only be terminated in cases of non-compliance or legal issues.
Before initiating the registration process for an IVD, the applicant must have an ISO 13485 certification, which verifies the product’s quality.
It is essential to have the product classification confirmed by the Central Drugs Standard Control Organization (CDSCO) before proceeding with the registration.

CONCLUSIONS

The regulatory pathways for IVDs importing and manufacturing new IVDs in India require careful planning and compliance with the Medical Devices Rules 2017. The process involves several stages, including obtaining a Test License, conducting Clinical Performance Evaluations, and securing the necessary Import License in India. By following these steps and ensuring that all regulatory requirements are met, manufacturers and importers can successfully bring their IVDs to the Indian market.

HOW MORULAA CAN HELP

Morulaa simplifies the complex regulatory pathways for IVDs in India, offering comprehensive support for In-vitro Diagnostic (IVD) IVDs. We assist manufacturers and importers with the preparation and submission of Test Licenses (Form MD-12/MD-16), managing Clinical Performance Evaluations (Form MD-24/MD-25), and submitting the final application for Import Licenses (Form MD-14). Beyond documentation, our team ensures full compliance with MDR-2017, manages post-approval changes, and provides specialized training and Central Drugs Standard Control Organization (CDSCO) liaison services. For foreign manufacturers without a local legal entity, Morulaa offers a strategic advantage by acting as your Importer on Record (IOR). We take legal responsibility for your shipments, ensuring all labeling and shelf-life requirements are met, and maintain your Registration and Import Licenses (Form MD-15). By handling the technical and logistical hurdles of importation, we serve as your local representative, ensuring your products reach the Indian market smoothly and remain in good standing with the Central Licensing Authority.