Currently, India’s medical device market heavily relies on imports. UK is among the top countries from which India imports medical devices. The demand for UK-imported medical devices is strong and projected to grow. Furthermore, the India-UK Free Trade Agreement (FTA) has further boosted this demand. It has eased access to UK-certified medical devices in the Indian market. The India-UK FTA has significantly reduced customs tariffs on critical UK medical devices. This will make them more affordable for Indian hospitals and consumers. Hence, India offers considerable opportunities for importing medical devices from UK. We have prepared this guide to help you easily get the license to import medical devices from UK.
Devices traded between India and UK
India imports advanced and specialised medical devices from UK.
- Ventilators
- Dental instruments
- Radiography apparatus
- Spectacles
- Breathing aids
- Disinfectants
- Surgical instruments
- Veterinary instruments
- IVD diagnostic instruments
- X-ray machines
- Orthopaedic appliances
Demand for medical devices from UK in India
- Growth of the Indian medical device market: Several factors are fueling the overall growth of the Indian medical device market. An increase in ageing population, increasing health concerns, growing prevalence of chronic diseases, expanding healthcare infrastructure are fuelling the demand. Hence, a wide range of medical devices, including those imported from the UK, are in demand in India.
- Demand for advanced medical devices: Demand for advanced devices is requiring companies to import medical devices from UK. Sophisticated technology-intensive equipment, such as radiography apparatus, are supplied by the UK. Additionally, the Indian hospital infrastructure is being modernised to improve patient care. Hence, advanced medical equipment, including diagnostic and treatment tools, has to be acquired from the UK.
- India-UK FTA: A free trade agreement between the United Kingdom and India was announced on May 6, 2025. India has agreed to reduce import duties on PLI-covered medtech after 6 years. Notably, this update is only for medical devices incentivized under the PLI scheme. As a result of this agreement, sophisticated British medical devices and technologies will become more accessible and affordable in India. Thus, further fuelling the demand for medical devices from UK.
We have highlighted the factors driving demand for medical devices from UK. Are you planning to start importing medical devices from UK? Well, you have landed in the right placed. We have prepared this guide just for you.
License to import medical devices from UK
CDSCO MD 15 license will be required to import medical devices from UK.
- Application form: To import medical devices from UK into India, an application has to be filed under Form MD 14.
- License: The license for importing medical devices from UK for sale and distribution in India is granted under the CDSCO MD 15.
Documents for obtaining license to import medical devices from UK
Documents have to be prepared for the CDSCO import license application.
- 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
- Power of attorney, in case an authorized agent has to be appointed
- Constitution details of Indian authorized agent for foreign medical device manufacturers.
- Notarized CE design certificate
- Notarized Declaration of Conformity stating the device complies with applicable regulatory requirements and standards.
- A copy of the latest inspection or audit report carried out by Notified bodies or the National Regulatory Authority within last 3 years
Accurate and correct documentation per guidelines is critical to easily get the license to import medical devices from UK. For a detailed list of necessary supporting documents, feel free to get in touch with us. Additionally, we provide document preparation support.
Who can apply for the CDSCO MD 15 license?
- Any wholesaler or importer who wants to import any medical device from UK 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.
- Any research institution in India who wants to import medical devices for clinical trials and research.
- Any hospital or healthcare provider who wants to import specialized medical devices, testing devices, or custom-made devices for their patients.
- An Indian authorized agent who has a valid wholesale license for the sale or distribution of medical devices.
Exemption from CDSCO medical device import license requirements
Recently, CDSCO has notified class A non-measuring and non-sterile devices will not require a CDSCO medical device import license. However, they will require a CDSCO medical device registration.
8-step guide to get license to import medical devices from UK into India?
- Check whether your medical device requires MD 15 license or a CDSCO medical device registration. Class A (measuring and sterile) B, C, and D medical devices will mandatorily require the MD-15 license. However, Class A non-measuring and non-sterile devices will require a CDSCO medical device registration.
- Register on the official CDSCO online application portal, SUGAM, for MD-15 license.
- Prepare and compile all necessary supporting documents per CDSCO guidelines.
- Fill inthe MD 14 application form with all the required details. Ensure accuracy and completeness.
- Upload the duly filed in application form along with the necessary documents on the online portal. Next, pay the necessary fees for the import license application. Once you have successfully completed all the steps and submitted your application, you will receive an application number.
- The CDSCO will review the MD-15 application for compliance with regulatory guidelines and verify the documents. They will try to check for any areas of non-conformities. 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.
- The CDSCO may inspect the importing firm’s medical device facility to verify whether it meets the quality and regulatory standards.
- 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 under MD 15. This license will permit you to import medical devices from UK for sale and distribution in India.
Rules for foreign medical device manufacturers planning to import medical devices
Foreign medical device manufacturers, not having a local 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 file the CDSCO medical device import license application on behalf of the foreign manufacturer. Furthermore, the authorized agent will act as a liaison between the foreign manufacturer and CDSCO. We at Pharmadocx Consultants are uniquely placed to act as an authorized agent for foreign medical device manufacturers.
CDSCO import license application fees
The CDSCO has established the medical device classification system to ease the license application process. The application fees and license required will depend on the CDSCO medical device class to which your device belongs to.
- Class A (sterile/measuring): A fee of$1,000 per site along with $50 per product will be required.
- Class B: A fee of$2,000 per site along with $1,000 per product will be required.
- Class C and D: A fee of$3,000 per site along with $1,5000 per product will be required.
Validity of the CDSCO import license
The CDSCO import license remains valid indefinitely. However, a license retention fee has to be paid every 5 years to retain its validity.
We provide end-to-end solutions to help you have a smooth regulatory journey. Drop an email at [email protected] or call/Whatsapp on 9996859227 to let us help you get the license to import medical devices from UK.
