Are you planning to get a CDSCO Test License in India? At Corpbiz, we ensure that CDSCO Test License approval is simplified solely for testing, evaluation, demonstration, or training purposes. Secured 798+ CDSCO test licenses since 2018, with a 100% success rate.
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A CDSCO test license, regulated under the Medical Device Rules, 2017, is mandatory for manufacturers or importers intending to manufacture or import medical devices solely for test, evaluation, demonstration, or training purposes in India. The licenses issued under Forms 11, CT-17, and Form-29 for the said purpose ensure that the medical devices used for testing comply with the prescribed safety, quality, and risk classification requirements.
CDSCO Test License for medical devices is simply a regulatory authorization issued after a comprehensive evaluation of the application, thereby ensuring compliance with government regulations and facilitating the import, sale, and distribution of medical devices in India. Partner with Corpbiz for end-to-end assistance in obtaining your CDSCO test license, including accurate documentation, device classification, test portal alignment, regulatory compliance, and coordination with CDSCO authorities.
Afraid of delays costing you months? Corpbiz cuts approval time by up to 60% with expert handling.
The benefits of obtaining a test license for medical devices are discussed below:
Obtaining a test license for medical devices enables controlled testing and evaluation to assess safety, performance, and intended functionality before commercial approval.
Obtaining a test license for medical devices facilitates research, performance evaluation, and design validation, which are essential during the medical device development lifecycle.
Obtaining a test license ensures lawful manufacture or import of medical devices for testing purposes in compliance with CDSCO requirements under the Medical Device Rules, 2017.
Obtaining a test license restricts device use to strictly approved testing, evaluation, demonstration, or training purposes, thereby reducing regulatory and patient safety risks.
Obtaining a test license for medical devices provides a compliant regulatory framework that encourages innovation while preparing devices for future commercial licensing.
Obtaining a test license for medical devices demonstrates regulatory discipline and compliance readiness, thereby strengthening credibility with CDSCO authorities, testing laboratories, and future partners.
Guidance on Device Classification
The key eligibility criteria for obtaining a CDSCO test license for medical devices are as discussed below:
The applicants eligible to apply for the CDSCO test license are as follows:
The list of documents needed for a test license in India under CDSCO is as discussed below:
The step-by-step guide to apply for CDSCO Test License in India is as follows:
Worried about the complexities in securing a CDSCO test license?
Guidance on Device Classification
The Central Drugs Standard Control Organisation in India has classified the test license India under CDSCO-
The test license to manufacture medical devices (MD-12/MD-13) allows the production of small batches of class A, B, C, or D medical devices for clinical investigation, testing, evaluation, demonstration, or training.
The test license to import medical devices (MD-16/MD-17) allows the import of small quantities of devices for similar purposes, such as manufacturing.
Guidance on Device Classification
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Connect with our experts who have deep domain knowledge of device classification, test license requirements, performance evaluation, and risk management.
We at Corpbiz provide end-to-end CDSCO test license support from eligibility assessment and device classification to test license issuance.
Get personalized consultations to understand eligibility, applicable forms, documentation requirements, and compliance obligations.
Corpbiz, having a PAN-India presence, ensures smooth coordination with CDSCO and State Licensing Authorities across India.
Legal Researcher
Written by Neha Dawra. Last updated on Jun 15 2026, 02:08 PM
Neha Dawra has 4+ years of experience in legal research and intellectual property advisory. Her expertise lies in analyzing IP laws, drafting structured legal content, and simplifying complex registration procedures into clear, simple insights.
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