Name: InVitro Diagnostic Device Import License in India - corpbiz
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In Vitro Diagnostic Device Manufacturing License

Looking to secure an in vitro diagnostic device manufacturing license in India? Connect with our regulatory team to ensure a smooth, timely, and 100% compliant approval for your CDCSO In Vitro diagnostic device manufacturing license in India.

What’s Included?

Filing via CDSCO/SUGAM Portal
Preparation of Device Master File
ISO-13485 Quality Management Support

Coordination with CDSCO & Drug Authorities
Inspection & Audit Readiness
IVD License Retention & Renewal

Secured 99 out of 100 CDSCO IVD Manufacturing License Successfully

In Vitro Diagnostic Device Manufacturing License - An Overview

The In Vitro Diagnostic Device Manufacturing License, regulated by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, is mandatory for entities intending to manufacture IVD devices for sale or distribution in India. The licensing process ensures that IVD devices (including reagents, kits, calibrators, etc.) comply with CDCSO-prescribed standards for safety, quality, performance, and risk-based classification.

Upon successful review and approval, the manufacturing license is granted by the State/Central Licensing Authority through the CDCSO SUGAM portal. The grant of the CDSCO IVD Manufacturing License further authorizes the manufacturer to legally manufacture and place the IVD device in the Indian market. Partner with Corpbiz to experience seamless coordination with CDSCO in obtaining an IVD device manufacturing license.

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What are the Benefits of Obtaining an IVD Manufacturing License in India?

The benefits of obtaining an IVD manufacturing license in India are as discussed below:

Access to Healthcare Market

Obtaining an IVD manufacturing license authorises the manufacturers to legally manufacture, sell, and distribute IVD devices, thereby allowing unrestricted access to diagnostic labs, healthcare institutions, and government tenders in India. It is one of the merits of the in vitro diagnostic device manufacturing license.

Enhanced Credibility & Trust

Obtaining a CDSCO IVD Manufacturing License in India or a state licensing authority demonstrates regulatory compliance, quality assurance, and technical competence, thereby strengthening trust among healthcare providers, distributors, and end users.

Assured Patient Safety & Product Quality

Obtaining an In vitro diagnostic device manufacturing license online mandates compliance with good manufacturing practices, quality management systems, and performance standards, thereby ensuring accurate diagnostic results in India.

Fosters Innovation & Growth

Obtaining a valid CDSCO IVD manufacturing license in India enables manufacturers to introduce new IVD products, expand manufacturing capacity, and scale operations, while aligning with India’s growing diagnostics and healthcare ecosystem.

Strengthens Supply Chain Integrity

Obtaining an In vitro diagnostic device manufacturing license helps strengthen transparency and integrity across the IVD supply chain, therefore enabling traceability, controlled sourcing of raw materials, batch-level documentation, and recall readiness.

Risk-Based Product Classification

Obtaining an In vitro diagnostic device manufacturing license online allows appropriate regulatory scrutiny based on device risk, thereby ensuring post-market surveillance and product accountability.

Eligibility Criteria for CDSCO IVD Manufacturing License

The key eligibility criteria to obtain a CDSCO IVD manufacturing license are as discussed below:

Must have a valid company registration and site ownership
Dedicated GMP-compliant premises with necessary infrastructure
Qualified technical staff as per regulatory norms
Implement QMS adhering to Medical Device Rules, 2017
IVD must be correctly classified based on intended use and risk profile
Must have access to NABL-recognized laboratories for product testing
Require a set of machinery for sealing & blister packaging, sterilization plant, testing equipment, etc.
Total investment varies based on the IVD product being manufactured

Who can Obtain an IVD Device Manufacturing Permit?

The applicants eligible to obtain an IVD device manufacturing permit in India are as follows:

Diagnostic and screening devices
Self-testing and companion diagnostics
Laboratory instruments and reagents
OEM and private label manufacturers
Importers and distributors

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What are the Documents Needed for an In Vitro Diagnostic Device Manufacturing License in India?

The list of documents needed to apply for an in vitro diagnostic device manufacturing license in India is as follows:

Cover letter
Duly filled application form
Receipt of the fees’ challan
Documents of the constitution of the firm
Partnership deed in case of a partnership firm
Memorandum and Articles of Association
Declaration from all proprietors/managing directors/partners
Documents of age and postal address of all partners/directors
Documents of site ownership or rent agreement
Declaration from manufacturing chemist
Registration from District Industries Centre
Consent to establish & operate
Performance Evaluation Report (if applicable)
Copy of Test License (if applicable)
Detailed Plant Master File (PMF) & Device Master File (DMF)
Consent letter from the principal manufacturing unit in case of a loan license
Wholesale licenses of the applicant loan licensee

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How to Obtain In Vitro Diagnostic Device Manufacturing License Online?

The step-by-step process for obtaining an In Vitro Diagnostic Device Manufacturing license online is as follows:

Step 1: Register the Company on the SUGAM Portal: The first step requires the applicant to create an account on the CDSCO SUGAM portal and register the manufacturing business by providing basic entity, premises, and authorized signatory details.
Step 2: Determine your IVD’s Risk Class: The next step requires the applicant to determine the IVD device's risk class based on its intended use and risk profile.
Step 3: Gather Crucial Documentation: Next, the applicants must gather the mandatory technical documents for obtaining an In Vitro Diagnostic Device Manufacturing license in India.
Step 4: Online Application Filing: In the next step, the applicants must file an online application through the SUGAM portal to the State or Central Licensing Authority, in the manner specified.
Step 5: Make Payment of Government Fees: The next step requires the applicant to pay the prescribed government fees online through the SUGAM portal.
Step 6: Conduct Site Inspection: In the next step, the licensing authority conducts a site inspection to verify QMS compliance or to address any deficiencies or queries raised within the stipulated timeframe.
Step 7: Grant of IVD Device Manufacturing License: Upon successful scrutiny and inspection, the licensing authority grants an IVD device manufacturing license, thereby authorizing the manufacturers to legally manufacture and market IVD devices in India.

Know about the Classification of In Vitro Devices in India?

Have a look at the following CDCSO classification of In Vitro Diagnostic Medical Devices based on the intended use and the level of risk to individuals and public health.

Low-Risk Class A

Low-risk class A IVD medical devices pose minimal risk to patients and public health. Specimen receptacles and general laboratory reagents are some of the examples of classification of low-risk class A in vitro devices in India.

Low to Moderate-Risk Class B

Low to moderate-risk class B IVD medical devices are those that support diagnostic decisions, such as clinical chemistry analysers, urine reagent strips, and routine biochemical diagnostic reagents.

Moderate to High-Risk Class C

Moderate- to high-risk class C IVD devices are those in which an incorrect result has a significant impact on patient management or on disease transmission control. It includes IVD tests for HIV, HBV, and HCV used for diagnostics.

High-Risk Class D

High-risk class D IVD devices pose a significant risk to public health, especially those used for blood safety and donor screening. It includes blood grouping sera, donor screening tests for HIV, HBV, and HCV.

Activities Regulated w.r.t IVD Device Manufacturing Permit

Have a look at the list of activities regulated by CLA and SLA with respect to the IVD device manufacturing permit-

Central Licensing Authority	State Licensing Authority
Import of IVD devices of all classes	Manufacture for sale or distribution of Class A or Class B IVD devices
Manufacture of Class C and Class D IVD devices	Grant of manufacturing and loan licenses for Class A and Class B IVDs
Grant of manufacturing and loan licenses for Class C and Class D IVDs	Sale, stock, exhibit or offer for sale or distribution of IVD devices of all classes
Clinical performance evaluation and approval of new in vitro diagnostic devices	Inspection of manufacturing sites for Class A and Class B IVD devices
Registration and oversight of notified bodies	Monitoring compliance with GMP, labelling, and storage requirements at the state level
Registration of laboratories for carrying out tests or evaluations	Suspension or cancellation of licenses for non-compliance within their jurisdiction
Grant of CDSCO test licenses for the manufacture or import of all classes of IVD	Supports surveillance and enforcement within the state
Post-market surveillance, vigilance, recalls, and regulatory enforcement

What are the Mandatory Forms Filed to Get a CDSCO IVD Manufacturing License in India?

The applicants dealing with IVD devices must file the following mandatory forms required to obtain a CDSCO IVD manufacturing license in India:

Form MD 3: An application filed for the grant of a license to manufacture, sell, and distribute Class A and Class B medical devices.
Form MD 4: An application filed for the grant of a loan license to manufacture Class A and Class B medical devices in India.
Form MD 5: A license issued by the State Licensing Authority to manufacture Class A or Class B medical devices for sale and distribution after successful review of Form MD 3.
Form MD 6: A loan license issued by the State Licensing Authority for manufacturing Class A and Class B medical devices at a third-party licensed manufacturing site.
Form MD 7: An application filed for the grant of a license to manufacture, for sale, and distribution of Class C and Class D medical devices.
Form MD 8: An application for a loan license to manufacture Class C and Class D medical devices, with manufacturing outsourced to another CDSCO-licensed facility.
Form MD 9: A manufacturing license issued by CDSCO for Class C or Class D medical devices, thereby authorizing the manufacturer to manufacture and market the IVD devices in India legally.
Form MD 10: A loan license issued by CDSCO for manufacturing Class C and Class D medical devices at a third-party licensed manufacturing site.

Corpbiz Services for In Vitro Diagnostic Device Manufacturing License in India

Pre-Application Regulatory Consultation

Connect with Corpbiz to conduct a pre-application feasibility consultation to understand better IVD risk classification, applicable licensing authority, and regulatory pathway..

Technical Documentation Review

Let our experts help you in preparing and reviewing technical files, including the Device Master File, Plant Master File, risk analysis, and labelling compliance.

Conformity Assessment & Inspection Readiness

We ensure internal conformity assessment checks and conduct gap analysis against MDR 2017 requirements.

Performance Evaluation Verification

We at Corpbiz assist in compiling and verifying performance testing data, analytical & clinical performance evaluation documents, and safety & validation reports.

QMS Integration

Corpbiz supports implementation and alignment with an ISO 13485-compliant QMS, covering SOP development, process control, and compliance with the MDR 2017 GAP.

Import License & Free Sale Certificate Support

Connect Corpbiz to get CDSCO Medical Device import license and free sale certificate support for businesses dealing with imported IVD devices in India.

Online Application Filing & Regulatory Coordination

We at Corpbiz ensure handling the complete application process on the CDSCO SUGAM portal, including portal registration, filing of applicable forms, and document uploading.

Post-Approval Compliance & License Retention Support

Our experts offer ongoing post-approval compliance and license retention support, including regulatory updates, continuous compliance monitoring, and license amendment services in India.

Why Trust Corpbiz for an In Vitro Diagnostic Device Manufacturing License Online?

10+ Years of Industry Experience: With 10+ years of experience in regulatory advisory, technical documentation, and licensing, Corpbiz is a trusted partner for medical device and IVD compliance in India.
10,000+ Technical & Regulatory Experts: Get access to a strong network of 10,000+ technical, legal, and medical device regulatory experts with hands-on experience in CDSCO registration and State Licensing Authority approvals.
Quick & Hassle-Free CDSCO Licensing: Our structured regulatory approach ensures error-free applications, faster processing, and minimal regulatory queries, helping speed up the approval timeline for IVD manufacturing licenses.
Domain Expertise in IVD Regulations: With in-depth knowledge of IVD risk classification, essential principles, ISO 13485, performance evaluation, and risk management, we ensure full compliance with the Medical Device Rules, 2017.
End-to-End IVD Licensing Support: Corpbiz offers complete lifecycle support from device classification and regulatory pathway mapping to license issuance, amendments, retention, and post-approval compliance.
One-on-One Regulatory Consultation: We help schedule one-on-one consultations with our CDSCO regulatory specialists to assess eligibility, documentation requirements, applicable forms, and compliance obligations.
PAN-India Presence: Corpbiz, with a nationwide presence, has successfully supported IVD manufacturing for Class A, B, C, and D devices, maintaining a strong approval success rate across diagnostic product categories.
Proven Track Record Across All IVD Devices: Corpbiz has successfully supported IVD manufacturing across Class A, B, C, and D devices, maintaining a strong approval success rate across diverse diagnostic product categories.
Regulatory Updates & Compliance Advisory: Corpbiz provides ongoing regulatory guidance, keeping clients updated on CDSCO notifications, amendments, inspections, and evolving IVD regulations.

FAQs on In Vitro Diagnostic Device Manufacturing License Online

An in vitro diagnostic medical device is used to test samples like blood, urine, or tissue outside the body to provide information about health, disease, or compatibility, thereby helping in diagnostics, monitoring, or treatment selection.

Some common IVDs used in the healthcare industry include blood grouping devices, blood coagulation analyzers, blood gas analyzers, human genetic tests, immunoassays, next-generation sequencing tests, blood glucose self-monitoring tests, COVID-19 tests, pregnancy tests, urinalysis test strips, influenza diagnostic tests, and HIV test kits.

The Medical Device Rules, 2017, are primarily available on the official website of India’s Central Drugs Standard Control Organisation.

The Medical Device & Diagnostic Division within the Central Drugs Standard Control Organisation is held responsible for reviewing IVD kits/ reagents in India.

In India, the laws regulating an in vitro diagnostic device manufacturing unit are the Medical Device Rules, 2017, thereby falling under the umbrella of the Drugs and Cosmetics Act, 1940.

The validity period for a test license (form MD-17 for import or manufacture) for an in vitro diagnostic kit and reagents in India is generally 3 years from the date of its issuance.

The activities regulated by the Central and State Licensing Authorities with respect to in vitro diagnostics in India include import, manufacture, clinical performance evaluation, new device approval, stocking, oversight of licenses/registrations, and post-market surveillance, ensuring safety and performance in accordance with the Medical Device Rules, 2017.

The Medical Devices & Diagnostics Division, also referred to as the In-Vitro Diagnostics Division, under the Central Drugs Standard Control Organization is held responsible for reviewing and regulating IVD kits and reagents under the Medical Device Rules, 2017.

Yes, the Medical Device Rules, 2017, do apply to in vitro diagnostic products in India.

In India, the IVDs are classified into four risk-based categories, like Class A (Low Risk), Class B (Low to Moderate Risk), Class C (Moderate to High Risk), and Class D (High Risk), with higher classes requiring a more stringent approval process from the Central Licensing Authority.

India has specifically prohibited the import, manufacture, sale, distribution, and use of IVD reagents/kits, such as Serodiagnostic test kits for the diagnosis of tuberculosis and Antibody-Detecting Rapid Diagnostic Tests (RDTs) for routine diagnosis of malaria.

Major post-approval changes for in-vitro diagnostics involve modifications that affect the device’s quality, performance, safety, or intended use and therefore require prior regulatory approval in India.

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In Vitro Diagnostic Device Manufacturing License

In Vitro Diagnostic Device Manufacturing License - An Overview