Planning to import medical devices from USA? With over 27 years of experience and more than 600 clients, we have extensive knowledge of the CDSCO regulations. We will leverage our expertise and industry knowledge to help you easily get the CDSCO MD 15 import license.
License to import medical devices from USA
- Form MD 14: To import medical devices from USA into India, an application has to be filed under Form MD 14.
- MD 15 license: The license for importing medical devices from USA for sale and distribution in India is granted under the CDSCO MD 15.
Documents required for securing the license to import medical devices from USA
We have provided an overview of the documents required to get the license to import medical devices from USA.
- 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.
- 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.
- Notarized CE design certificate
For a detailed list of necessary supporting documents, feel free to get in touch with us. Furthermore, we provide document preparation support. Our team will not only prepare the documents but also compile them per CDSCO regulatory guidelines. Accurate and correct documentation per guideline is critical for smooth regulatory approval.
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.
- 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 importer of special rapid test kits.
- An Indian authorized agent who has a valid wholesale license for the sale or distribution of medical devices.
Exemption from CDSCO import license requirements
Class A non-measuring and non-sterile medical devices have been exempted from import license requirements. However, they will require a CDSCO medical device registration.
Demand for medical devices from USA
Despite initiatives to promote domestic medical device production, India’s medical device market is still 70–80% import-dependent. USA remains the largest supplier, providing high-end equipment, such as imaging devices and implants. Demand for medical devices from USA is driven by India’s large population, growing healthcare sector, and a reliance on imported high-end technology. Imports from the USA are heavily concentrated in high-tech segments, including:
- Diagnostic imaging apparatus (e.g., MRI, CT scanners)
- Cardiovascular and orthopedic implants (e.g., artificial joints)
- Radiotherapy and other advanced electronic equipment
India still heavily relies on imports for high-tech equipment. Thus, maintaining a strong demand for medical devices from USA. Hence, importing medical devices from USA is a profitable business. You have to mandatorily secure the CDSCO license to import medical devices from USA to market your products in India.
How to get the license to import medical devices from USA into India?
- Step 1: 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.
- Step 2: Register on the official CDSCO online portal, SUGAM.
- Step 3: Prepare and compile all necessary supporting documents per CDSCO guidelines.
- Step 4: Fill in the MD 14 application form with all the required details. Ensure accuracy and completeness.
- Step 5: 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.
- Step 6: 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.
- Step 7: 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
- Step 8: The CDSCO may inspect the importing firm’s medical device facility to verify whether it meets the quality and regulatory standards.
- Step 9: 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 USA for sale and distribution in India.
CDSCO import license application fees
To get the license required to import medical devices from USA, you need to pay the import license application fees. The CDSCO has formulated 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.
Pro tips for smooth CDSCO import license application
- Power of Attorney must be prepared per Medical Device Rules (MDR), 2017
- Product name and model numbers must be consistent across POA, FSC, product label, and other technical documents
- Notarization of documents must follow MDR, 2017, guidelines
- Device master file (DMF), plant master file (PMF), and other technical documents need to be prepared in the format prescribed in MDR, 2017
Rules for foreign medical devices manufacturers
Foreign medical device manufacturers, not having 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.
Why should you choose Pharmadocx Consultants?
Securing the license to import medical devices from USA can be tricky from filling the form correctly to preparing the necessary documents. Avail our comprehensive CDSCO MD 15 license application support service. We offer:
- Expertise in CDSCO regulations
- Document preparation support
- CDSCO query response support
- Authorised agent services
- Post-license support
- Client-centric approach
- Cost & time efficient solutions
Call/Whatsapp on 9996859227 or email at [email protected] to easily get your license to import medical devices from USA into India.
