India is aiming to reduce its import dependency and boost domestic medical device manufacturing. However, a major supply of India’s medical device requirements comes from China. India is still heavily import dependant for fulfilling its medical device demands. Notably, demand for medical devices is increasing in India. Aging population, rise in chronic diseases, and increase in health awareness are some of the factors driving the demand. A considerable number of medical devices has to be imported from China to cater to these demands. Moreover, Chinese products are cheap and affordable, thereby have a competitive advantage over other medical device import markets. Furthermore, devices at the lower end of the technology spectrum, such as consumables and disposables, are mostly imported from China. Are you into medical device import business? Planning to import from China? We have prepared this guide on how to import medical devices from China just for you.
In this guide, we have detailed the license required, eligibility for the CDSCO medical device import license, and documents required. Additionally, we have mentioned the fees required. Also, we have provided a step-by-step MD 15 license application guide along with some pro tips.
License to import medical devices from China
- Form MD 14: To import medical devices from China into India, an application has to be filed under Form MD 14.
- MD 15 license: The license for importing medical devices from China for sale and distribution in India is granted under the CDSCO MD 15.
Exemption from 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.
Rules for foreign medical devices manufacturers
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.
Who can apply for the CDSCO MD 15 license?
- Any wholesaler or importer who wants to import any medical device from China 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.
Documents for obtaining license to import medical devices from China
Supporting documents have to be prepared for the CDSCO import license application. These documents have a vital role in demonstrating regulatory compliance.
- 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 guidelines is critical to easily get the license to import medical devices from China.
CDSCO 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.
How to get the license to import medical devices from China 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 6: 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 7: 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
- 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 China for sale and distribution in India.
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
Will a change in the authorized agent require a fresh import license application?
Yes, a change in the Indian authorized agent will require a fresh import license application.
Can the CDSCO import license be transferred to another entity or individual?
No, you cannot transfer your CDSCO import license to another entity or individual.
Avail our comprehensive CDSCO MD 15 license application support service, to secure your license in a hassle-free manner. Additionally, as authorized agents, we can help foreign companies register their medical device business in India. To easily secure the license to import medical devices from China, call/Whatsapp on 9996859227 or email at [email protected].
