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CDSCO import license for medical devices, operating under the National Regulatory Authority of the Ministry of Health and Family Welfare regulated import, manufacture, and distribution of medical devices in India. The issuance of CDSCO import license for medical devices is mandatory to ensure that the products meet India’s safety, quality, and performance standards before entering the Indian market.
Once approved, CDSCO issues the CDSCO import license for medical devices in Form MD-15 via the online portal, legally authorizing the Indian Authorised Agent to import and distribute medical devices in India. With Corpbiz as your compliance partner, you receive comprehensive import license support under the Medical Device Rules, 2017, ensuring faster approvals, zero compliance gaps, and uninterrupted market entry.
Securing a CDSCO medical device import license in India under the Medical Devices Rules, 2017, offers the following benefits, as discussed below:
Obtaining a CDSCO medical device import license in India authorizes the importer to legally import, manufacture, and sell medical devices, thereby enabling access to the Indian marketplace.
CDSCO import license for medical devices ensures that medical devices meet prescribed safety, quality, and performance standards, thereby making them safe for patient and public use.
The CDSCO medical device import license in India helps manufacturers and importers to avoid penalties, product recalls, and regulatory actions due to non-compliance.
Securing CDSCO medical device registration helps reduce customs clearance delays, thereby ensuring uninterrupted import and distribution of medical devices in India.
CDSCO import license for medical devices enables participation in government tenders, hospital procurement, and institutional sales across India.
CDSCO medical device registration ensures proper labelling, instructions for use, and post-market surveillance obligations are met.
The key eligibility criteria to obtain a CDSCO import license for medical devices in India are as discussed below:
The applicants eligible to apply for a CDSCO import license for medical devices under CDSCO are as discussed below:
The documents required to obtain a CDSCO medical device import license in India are as discussed below:
The step-by-step process to obtain an online CDSCO import license for medical devices in India is as follows:
The key differences between form MD-14 and form MD-15, used to secure a CDSCO import license for medical devices in India, are discussed below:
| S. No. | Aspect | Form MD-14 | Form MD-15 |
|---|---|---|---|
| 1. | Meaning | Form MD-14 is an application form submitted by the Indian Authorized Agent to CDSCO, requesting approval to import specific medical devices into India. | Form MD-15 is the import license issued by CDSCO after reviewing and approving the legal permission to import and distribute medical devices in the Indian market. |
| 2. | Issuing Authority | Filed by the Indian Authorized Agent through the CDSCO portal. | Issued by CDSCO upon successful evaluation. |
| 3. | Legal Validity | Does not authorize the import or sale of medical devices. | Legally authorizes the import, distribution, and marketing of medical devices in India. |
| 4. | Nature | Application or request for import approval. | Regulatory approval or license issued after review. |
| 5. | Outcome | Leads to regulatory review and evaluation by CDSCO. | Enables customs clearance and market entry in India. |
Connect with Corpbiz for an expert consultation to understand CDSCO eligibility, device classification, applicable forms, documentation requirements, and approval timelines.
We assist in identifying the correct risk class and regulatory pathway for your medical device, in accordance with CDSCO guidelines.
We help appoint, validate, and authorize an Indian authorized agent, as required for foreign manufacturers.
Our professionals at Corpbiz offer end-to-end verification of mandatory documents, including Device Master File, Plant Master File, Free Sale Certificate, and IFU.
Our experts at Corpbiz ensure complete handling of CDSCO portal registration, Form MD-14 submission, fee payment, and document uploading.
Get our expert guidance on import compliance, customs clearance readiness, and regulatory labelling requirements in India.
Get access to a strong network of medical device regulatory professionals, compliance specialists, and documentation experts experienced in CDSCO approvals.
Our team of experts ensure accurate Form MD-14 filing, complete documentation, and practical compliance to minimise delays and rejections.
Corpbiz has 10+ years of experience in healthcare regulatory compliance, licensing, and regulatory approvals.
Our team possesses in-depth knowledge of CDSCO regulations, device classification, and import licensing procedures.
Our team at Corpbiz ensures end-to-end support from the Indian Authorized Agent appointment to the grant of an import license.
Connect with a dedicated CDSCO compliance manager to ensure application tracking, CDSCO coordination, and real-time updates.
With nationwide operations, we coordinate seamlessly with CDSCO and related authorities across India.
Corpbiz successfully assisted manufacturers and importers across multiple device categories in obtaining a CDSCO import license.
We offer ongoing assistance for license amendments, endorsements, renewals, and regulatory compliance in India.
Legal Researcher
Written by Neha Dawra. Last updated on Jun 16 2026, 07:53 AM
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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