Japan is a top global exporter of medical devices, especially in diagnostic and imaging equipment. Japan has a reputation for manufacturing high-quality and reliable products. India has a growing medical device market and increasing demand for advanced healthcare products. Hence, it offers opportunities for Japan to market its technologically advanced medical devices. India primarily imports high-end medical devices, diagnostic, and imaging equipment from Japan. Japanese manufacturers are seen as a viable alternative to China for medical device imports. Thus, there is considerable demand for medical devices from Japan. We have prepared this guide on how to import medical devices from Japan to provide an overview of regulatory requirements.
Why is there a demand for Japanese medical devices in India?
Japanese medical devices are known for their high-quality manufacturing, accuracy, and reliability. Hence, they are sought after in international markets, such as India. India’s growing healthcare sector requires a wide range of devices that Japanese manufacturers can supply:
- Cardiovascular devices: Equipment for the diagnosis and treatment of heart-related conditions is in high demand due to rising cardiovascular disease rates in India.
- Diabetes care: The high prevalence of diabetes in India creates a large market for Japanese products, such as insulin pumps.
- Diagnostic imaging: Advanced imaging systems, including AI-powered tools, are sought after by Indian healthcare professionals.
To import medical devices from Japan, it is important to understand, which devices are in demand in India. Hence, we have provided an overview of the most sought after Japanese medical devices in India.
5 factors driving demand for Japanese medical devices in India
- Quality and reliability: Japanese devices are known for their high-quality manufacturing, accuracy, and reliability. Hence, these products are in high demand in India.
- Alternative to Chinese medical devices: India wants to diversify its supply chains and reduce dependence on a single country, such as China. Japanese medical devices are seen as a viable alternative to China for medical device imports.
- Advanced technology: India’s domestic manufacturers cannot cater to the high-end medical device demands. Japan is a leading manufacturer of advanced and high-end medical devices, including complex diagnostic and imaging equipment. Hence, Japan caters to India’s sophisticated healthcare needs.
- Increase in prevalence of lifestyle diseases: With the rise of lifestyle diseases, demand is increasing for specialized equipment used in cardiology, diabetes care, and other chronic disease management. Japan specialises in manufacturing medical devices in these sectors.
- Growth in private healthcare: Increase in private healthcare sector is driving the demand for modern, high-tech medical equipment for new and expanding facilities. Japan is the leading manufacturer of advanced and high-end medical devices, thereby catering to the needs of the growing private healthcare sector.
License to import medical devices from Japan
- Form MD 14: To import medical devices from Japan into India, an application has to be filed under Form MD 14.
- MD 15 license: The license for importing medical devices from Japan for sale and distribution in India is granted under the CDSCO MD 15.
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.
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.
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.
Documents required for securing the license to import medical devices from Japan
Supporting documents have to be prepared for the MD-15 license application. These documents have a vital role in demonstrating regulatory compliance. Accurate and correct documentation per guideline is critical for smooth regulatory approval. We have provided an overview of the documents required to get the license to import medical devices from Japan.
- 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.
CDSCO import license application fees
To get the license required to import medical devices from Japan, you need to pay the import license application fees. 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 Japan into India?
- Check license requirements: 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 online: Register on the official CDSCO online portal, SUGAM.
- Document preparation: Prepare and compile all necessary supporting documents per CDSCO guidelines.
- Form filling: Fill in the MD 14 application form with all the required details. Ensure accuracy and completeness.
- Filling the application: 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.
- CDSCO review: 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.
- CDSCO query response: 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
- Facility inspection: The CDSCO may inspect the importing firm’s medical device facility to verify whether it meets the quality and regulatory standards.
- 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 medical devices from Japan 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.
To easily get your license to import medical devices from Japan, call/Whatsapp on 9996859227 or email at [email protected].
