The CDSCO regulates the import of medical devices into India. Hence, you have to mandatorily secure the CDSCO MD15 import license to import your medical devices into India. It is the gateway for importing and selling imported medical devices in India. In this blog, we have prepared a detailed guide to help you easily get the CDSCO MD 15 license in 2026. We have covered the complete procedure and documents as well as other requirements.
Starting a medical device import business in India in 2026 holds strong potential due to the country’s dependence on imports, especially for advanced imaging systems, pacemakers, and diagnostic equipment. Rising healthcare demand, hospital expansion, and insurance penetration are fueling consumption of high-quality devices that domestic manufacturers cannot yet fully supply. Moreover, India’s growing middle class and private hospital chains are increasingly willing to pay for premium imported technologies. Hence, it is profitable to start a medical device import business in India in 2026.
CDSCO medical device import license
- Form MD 14: The application to obtain CDSCO medical device import license has to be filed on Form MD 14.
- CDSCO MD 15 license: The license to import Class A (measuring and sterile) B, C, and D medical devices is granted on MD 15.
Who can apply for the CDSCO MD 15 license?
- Any wholesaler or importer who wants to import any medical devices for sale and distribution in India
- Any foreign medical device manufacturer who wants to supply medical devices in India. However, the foreign manufacturer will have to file the application via the authorised agent.
- An Indian authorized agent who has a valid wholesale license for the sale or distribution of medical devices.
Rules for foreign medical devices manufacturers
Foreign medical device manufacturers who do not have any presence in India planning to sell their devices in India will have to appoint an authorized agent. The authorized agent must have a valid wholesale license (MD 42). Thus, the Indian authorized agent will act on behalf of the foreign manufacturer in India. The agent will file the CDSCO MD15 import license application on behalf of the foreign manufacturer. Furthermore, the authorized agent will act as a liaison between the foreign manufacturer and CDSCO.
Documents required for CDSCO MD15 import license application
- Cover letter
- Application form
- Self-attested copy of valid manufacturing license demonstrating the device is manufactured in accordance with the regulatory requirements of the country of origin.
- Plant master file
- Device master file
- Notarized copy of overseas manufacturing site or plant registration in the country of origin issued by the competent authority
- Notarized copy of ISO 13485 certificate of the actual medical device manufacturer
- Duly apostilled/notarized copy of Free Sale Certificate from National Regulatory Authority of country of origin
- Full Quality Assurance Certificate/CE type examination certificate/CE product quality assurance certificate
- Notarized Declaration of Conformity stating the device complies with applicable regulatory requirements and standards.
- Notarized CE design certificate
- A copy of the latest inspection or audit report carried out by Notified bodies or the National Regulatory Authority within last 3 years
- Power of attorney, in case an authorized agent has to be appointed
- Constitution details of Indian authorized agent for foreign medical device manufacturers.
We have provided an overview of the necessary supporting documents for securing the CDSCO MD15 import license. For a detailed list of documents required for obtaining the CDSCO medical device import license, feel free to reach out to us. Additionally, we will help you prepare and compile the documents as per CDSCO requirements.
Step-by-step guide to easily get CDSCO MD15 import license
- Check whether your medical device requires CDSCO MD 15 license: First, it is important to appropriately check your medical device’s CDSCO class. This is because it will determine the next course of action. Class A non-measuring and non-sterile devices will not require a medical device import license. They will require a CDSCO medical device registration. However, all other medical devices, Class A (measuring and sterile) B, C, and D medical devices, will mandatorily require the CDSCO MD15 import license.
- Import license applicant registration: Register on the official CDSCO online portal, SUGAM. You have to create a user account and login to the portal.
- CDSCO MD15 import license application: You have to apply online on the SUGAM portal. Appropriately fill in the MD 14 form. Then, upload all necessary supporting documents. Next, pay the necessary fees for the import license application online. Once you have successfully completed all the steps and submitted your application, you will receive an application number. This application number will serve as a reference point for tracking your application.
- Application assessment by CDSCO: The CDSCO will review the MD 15 license application for compliance with regulatory guidelines and verify the documents. They will try to check for any areas of non-conformities.
- CDSCO query response: CDSCO may raise queries regarding your application. It is important to promptly and appropriately respond to all queries. Response should be provided in a timely manner along with additional documents (if required) to support the response.
- CDSCO medical device import license grant: CDSCO will evaluate all the information provided and check the response to the queries. If satisfied, they will approve the application. The CDSCO medical device import license will be granted on MD 15. This license will permit you to import the medical devices specified in your application.
CDSCO medical device import license validity
The CDSCO MD15 import license remains valid indefinitely unless cancelled or suspended. However, the license retention fee must be paid every five years from the date of issuance. If the license retention fee is not paid within the stipulated period, the license will be deemed cancelled.
Pharmadocx Consultants team can help you easily get the CDSCO MD15 import license
The CDSCO medical device import license application process can be tricky from filling the form correctly to preparing the necessary documents. Furthermore, if the CDSCO raises any query, you will have to respond appropriately. Additionally, as foreign medical device manufacturers, you have to appoint an authorised agent.
We at Pharmadocx Consultants have extensive knowledge and expertise in the CDSCO regulatory guidelines and import license application process. Additionally, as authorized agents we can help foreign companies register their medical device business in India. With our comprehensive CDSCO MD15 import license application support service, you need not worry. We provide end-to-end solutions so that you have a smooth regulatory journey. Drop an email at [email protected] or call/Whatsapp on 9996859227 and we will help you secure your CDSCO import license in a hassle-free manner.
FAQs
What is the CDSCO medical device import license?
CDSCO MD 15 license is the CDSCO medical device import license. CDSCO MD 15 license is mandatorily required to import medical devices into India.
Do all medical devices require CDSCO MD 15 license for import?
Only Class A (measuring and sterile) B, C, and D medical devices require CDSCO MD 15 license for import. Class A non-measuring and non-sterile devices do not require CDSCO MD 15 import license.
Do class A non-measuring and non-sterile devices require CDSCO MD 15 import license?
CDSCO has recently notified class A non-measuring and non-sterile devices won’t require CDSCO MD 15 import license. However, they will require a CDSCO medical device registration.
What is the CDSCO medical device import license application form?
CDSCO medical device import license application form is MD 14.
Do foreign manufacturers require authorised agent service?
Yes, foreign manufacturers who do not have a local presence in India require an authorised agent service.
Is a free sale certificate required to get CDSCO medical device import license?
Yes, a free sale certificate is required to get CDSCO medical device import license.
