CDSCO Import Licence (MD-15) Consultants for Medical Devices

A CDSCO import licence in Form MD-15 is required before a foreign-made medical device or IVD can be imported into India for sale or distribution. Medfins International works with overseas manufacturers and their Indian partners to classify the devices, build the Device and Plant Master Files, prepare the power of attorney and file the MD-14 application on CDSCO’s online portal.

What is a CDSCO import licence?

Under the Medical Devices Rules, 2017, no medical device or IVD manufactured outside India may be imported for sale or distribution without a licence from the Central Licensing Authority. The application is made in Form MD-14 and the licence is issued in Form MD-15.

The CDSCO import licence lists the overseas manufacturer, each manufacturing site and the approved devices. It remains valid as long as the retention fee is paid every five years and licence conditions are met. Since October 2023 the requirement applies across all risk classes.

Who applies and who needs it?

The applicant is not the foreign manufacturer itself but its Indian authorised agent. The agent must hold a manufacturing licence, a wholesale licence or a registration certificate in Form MD-42, and must be appointed through a power of attorney from the manufacturer.

• Overseas manufacturers entering the Indian market for the first time.
• Indian importers and distributors representing a foreign brand.
• Existing licence holders adding new devices, sites or variants.
• Companies changing their Indian agent or transferring a licence.

Classification and scope

Devices are classified as Class A, B, C or D according to the First Schedule and the classification lists issued by CDSCO. Class determines the fee, the review depth and how much evidence is expected. Certain Class A non-sterile, non-measuring devices follow a simplified online registration route instead of a full MD-15 licence, so confirming class and sub-category at the start can save significant effort.

Devices without a predicate in India, and new IVDs, require prior permission (Forms MD-26 or MD-28). This may involve clinical investigation or clinical performance evaluation data before an import licence is issued.

Documents required

CDSCO publishes a checklist for MD-15 applications. The core items typically include:

• Form MD-14 with proof of fee payment under the Second Schedule.
• Indian agent’s wholesale licence, manufacturing licence or MD-42 registration.
• Power of attorney and agent undertaking as per the Fourth Schedule, duly authenticated (for example through apostille or the Indian embassy).
• Free sale certificate from the regulator of the country of origin, or marketing authorisation from the USA, UK, EU, Canada, Japan or Australia.
• ISO 13485 certificate and, where applicable, full quality assurance or CE certificates.
• Plant Master File and Device Master File for each device or group.
• Labels, instructions for use and India-specific labelling particulars.
• Test reports, batch release or certificate of analysis data and post-market history.

Step-by-step process

1. Regulatory assessment: confirm class, grouping, predicate status and any exemption route.
2. Agent set-up: confirm the agent’s licence and prepare the power of attorney and undertaking.
3. Dossier compilation: Device Master File, Plant Master File and certificates, with notarisation or apostille where required.
4. Online submission of Form MD-14 on the CDSCO medical device portal (National Single Window System) with fees.
5. Technical review by CDSCO, which may include expert committee consideration for certain devices.
6. Query response within the time allowed, with clear cross-references to the dossier.
7. Grant of MD-15, followed by import clearance, post-market surveillance and retention obligations.

Timelines and what affects them

The rules set time limits for CDSCO to act on complete applications. In practice, the time to an MD-15 licence depends mainly on how complete the dossier is when first filed. Key drivers include:

• How quickly the manufacturer can supply legalised certificates and the power of attorney.
• The number of devices, sites and groups in the application.
• Whether the device has a predicate and a clear regulatory history in reference countries.
• The quality of responses to CDSCO queries.

An overseas site inspection is possible under the rules, although most applications are decided on the documents. We plan each project around these drivers and keep both manufacturer and agent informed at every stage.

Common reasons for queries and delays

• Free sale certificate that does not name the exact device models or manufacturing site.
• Power of attorney that is not authenticated correctly or has expired.
• Device Master File copied from another market without India-specific content.
• Mismatch between model names on labels, certificates and the application.
• Incorrect grouping, leading to extra fees or rejection of some devices.

After the licence is granted

Holding an MD-15 is the start of ongoing compliance, not the end. Consignments must match the licensed devices, sites and labelling, and port authorities check this at clearance. The licence holder must also handle complaints, report adverse events under the materiovigilance programme, manage recalls and notify CDSCO of major changes such as a new site, design change or change of agent.

How Medfins International supports you

Medfins International has supported clients from more than 15 countries on over 175 regulatory projects. As a CDSCO import licence consultant, we act as a single point of contact between your global regulatory team and your Indian partner. Our support includes:

• Classification, grouping and route planning, including exemption checks.
• Drafting the power of attorney, undertaking and cover letters in the required format.
• Converting your existing technical file into an India-compliant Device Master File.
• Filing on the portal, tracking the application and drafting query responses.
• Post-approval work: new product endorsements, site changes and retention.

If you need samples in India before approval, ask about a test licence in Form MD-17. To plan your Indian market entry, speak to our team.

Medical device import license in India: who needs MD-15?

Every overseas medical device or IVD entering India needs an MD-15 import license, applied for in Form MD-14 by the Indian authorised agent. The licence lists the manufacturer, each manufacturing site and every approved device. See also IVD import license in India and our CDSCO registration fees table.

Frequently asked questions