India has a rapidly growing domestic medical device manufacturing industry. However, India still heavily relies on medical device imports to fulfil the requirements of the healthcare system. To import medical devices into India, importers have to mandatorily obtain a medical device import license from the CDSCO. The CDSCO has a vital role in ensuring the safety and quality of medical devices being imported into India. Its aim is to safeguard public health and ensure the entry of safe and effective devices into India. The medical device import license grant process is well-structured involving evaluation and inspection. The medical device import license (MD-15 license) is granted only to applicants who comply with regulatory guidelines and requirements. In this blog, we have detailed what is the CDSCO MD 15 license. Additionally, we have given an idea of how to obtain the medical device import license.

CDSCO medical device import license

The CDSCO regulates the import of medical devices into India. Hence, you have to secure the CDSCO medical device import license to import your medical devices into India.

Form MD 14

Form MD 14 is the application form for securing the license to import medical devices into India. To import medical devices into India, an application has to be filed under Form MD 14.

CDSCO MD 15 license

The CDSCO MD 15 license is granted for importing medical devices into India. It is the gateway for importing and selling imported medical devices in India. MD-15 license is a mandatory requirement for importing all Class A (measuring and sterile) B, C, and D medical devices. Notably, CDSCO has recently notified class A non-measuring and non-sterile devices won’t require a medical device import license. However, they will require a CDSCO medical device registration.

Rules for foreign medical devices manufacturers

Foreign medical device manufacturers 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 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.

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.

Documents required for CDSCO MD 15 license application

1. Self-attested copy of valid manufacturing license demonstrating the device is manufactured in accordance with the regulatory requirements of the country of origin.
2. Plant master file
3. Device master file
4. Notarized copy of overseas manufacturing site or plant registration in the country of origin issued by the competent authority
5. Notarized copy of ISO 13485 certificate of the actual medical device manufacturer
6. Duly apostilled/notarized copy of Free Sale Certificate from National Regulatory Authority of country of origin
7. Full Quality Assurance Certificate/CE type examination certificate/CE product quality assurance certificate
8. Notarized Declaration of Conformity stating the device complies with applicable regulatory requirements and standards.
9. Notarized CE design certificate
10. A copy of the latest inspection or audit report carried out by Notified bodies or the National Regulatory Authority within last 3 years
11. Power of attorney, in case an authorized agent has to be appointed
12. 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 MD 15 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.

CDSCO MD 15 license application process

1. 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 MD-15 license.

2. Import license applicant registration

The MD 15 license application has to be submitted on the CDSCO’s official online portal, SUGAM. For which you must register on the official CDSCO online portal. You have to create a user account and login to the portal.

3. CDSCO MD 15 license application

You have to apply online on the SUGAM portal. Appropriately fill in the MD 14 form. Then, upload all necessary certificates and documents mentioning product details and demonstrating regulatory compliance among other important information. 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.

4. Assessment by CDSCO

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. For novel products, a medical device advisory committee (MDAC) review will be conducted. Furthermore, the 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.

5. CDSCO facility inspection and audit

The CDSCO may inspect the importing firm’s medical device facility to verify whether it meets the quality and regulatory standards. The facility should be inspection ready and you should be prepared to address any concerns raised during the audit.

6. 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 under MD-15. This license will permit you to import the medical devices specified in your application.

License validity

The CDSCO MD 15 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.

How can Pharmadocx Consultants help you secure the CDSCO MD 15 license?

We have extensive knowledge and expertise in the CDSCO regulatory guidelines and license application process. Additionally, as authorized agents we can help foreign companies register their medical device business in India. The medical device import license application 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. With our comprehensive CDSCO MD 15 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 import license.