In vitro diagnostic devices (IVDs) have diverse applications in the healthcare industry. India is still heavily import dependant for fulfilling its IVD needs. Hence, India imports large quantities of IVDs. Thus, Central Drugs Standard Control Organisation (CDSCO) has developed strict regulations for IVDs entering the Indian market. IVDs being imported are regulated for quality, efficacy and safety. Compliance with all applicable Indian IVD regulations is mandatory to import IVDs into India. The apex regulatory body strictly enforces these regulations to ensure the Indian healthcare industry has access to the highest quality devices. Furthermore, it can take corrective actions in case of regulatory non-compliance. Hence, securing the CDSCO IVD import license is a mandatory requirement for importing IVDs into India. In this blog, we have prepared a detailed guide on how to import IVDs for sale in India.
What are IVDs?
In vitro diagnostic devices (IVDs) are tests, instruments, reagents, and systems used to analyze human biological specimens, such as blood, tissue, or urine, outside the body. IVDs are used to detect diseases, monitor health conditions, and guide treatment decisions. They range from simple home pregnancy tests to complex high-throughput laboratory and in-home testing devices. IVDs help in diagnosis, monitoring, and screening of diseases. They are used to guide treatment decisions and public health strategies. IVDs can be used in central laboratories, hospitals, point-of-care facilities (like clinics), and even at home.
Examples: Blood glucose meters, pregnancy tests, HIV test kits, COVID-19 PCR tests, and genetic testing kits.
Types of IVD devices
- Laboratory analyzers: Machines that run blood chemistry, hematology, or immunoassay tests.
- Point-of-care devices: Portable instruments, such as blood glucose meters or handheld COVID-19 antigen test kits.
- Home-use kits: Pregnancy test strips, cholesterol self-test kits.
- Reagents and consumables: Chemicals, buffers, and cartridges specifically designed for diagnostic use.
- Software: Diagnostic algorithms or apps that interpret test results (regulated as part of the IVD system).
Thus, IVDs play an indispensable role in healthcare industry. Hence, to import IVDs for sale in India, you need to comply with the CDSCO IVD regulations.
CDSCO requirements to import IVDs for sale in India
CDSCO strictly regulates all IVDs entering the Indian market. IVD importers are required to mandatorily secure the CDSCO IVD import license to import IVDs for sale in India.
CDSCO IVD import license
- Form MD 14: To import IVDs for sale in India, an application has to be filed under Form MD 14.
- MD 15 license: CDSCO MD 15 license is granted for importing IVDs for sale and distribution in India.
Documents required to import IVDs for sale in India
Various supporting documents have to be prepared for demonstrating regulatory compliance of the IVDs. Accurate and correct documentation per guidelines is critical for smooth CDSCO regulatory approval. We have listed the documents necessary for CDSCO MD 15 license application.
- Notarized copy of overseas manufacturing site or plant registration in the country of origin issued by the competent authority
- 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 ISO 13485 certificate of the actual IVD 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
- Notarized CE design certificate
- 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 IVD manufacturers
We provide comprehensive document preparation support. For a detailed list of necessary supporting documents or for document preparation support, feel free to get in touch with us.
Who can apply for the CDSCO IVD import license?
- Any wholesaler or importer who wants to import any IVDs for sale and distribution in India
- Any foreign IVD manufacturer who wants to supply IVDs 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 IVDs.
- Any research institution in India who wants to import IVDs for clinical trials and research.
- Any hospital or healthcare provider who wants to import specialized IVDs or custom-made devices for their patients.
The import license applicant is required to possess a wholesale license (Form 20/21 B) or a registration certificate (Form 41/42).
Guidelines for foreign IVD manufacturers
Foreign IVD manufacturers who do not have a local presence in India and are planning to sell their devices in India will have to appoint an authorized agent. The authorized agent is required to have a valid wholesale license (MD 42). Thus, the Indian authorized agent will file the CDSCO IVD import license application on behalf of the foreign manufacturer. Furthermore, the agent will act as a liaison between the foreign manufacturer and CDSCO.
How to obtain CDSCO IVD import license to import IVDs for sale in India?
- Applicant registration: Register on the official CDSCO online portal, SUGAM.
- Document preparation: Prepare and compile all necessary supporting documents per CDSCO guidelines.
- CDSCO IVD import license application: Fill in the MD 14 application form with all the required details. Ensure accuracy and completeness.
- Online submission: Upload the duly filed in application form along with the necessary documents on the online portal. Next, pay the necessary fees for the CDSCO IVD import license application. Once you have successfully completed all the steps and submitted your application, you will receive an application number.
- CDSCO application review: The CDSCO will review the application for compliance with regulatory guidelines and verify the documents. They will check for any areas of non-conformities.
- CDSCO query response: CDSCO officials may raise queries asking for additional clarification and further documentation. 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 and audit: The CDSCO may inspect the importing firm’s IVD facility to verify whether it meets all applicable quality and regulatory standards. CDSCO audits are conducted for ensuring regulatory compliance.
- MD 15 license approval and grant: CDSCO will evaluate all the information provided and check the response to the queries. If satisfied, they will approve the application. The CDSCO IVD import license will be granted under MD 15. The CDSCO MD 15 license will permit you to import IVDs for sale in India.
Validity of the CDSCO import license
The CDSCO IVD import license remains valid indefinitely. However, a license retention fee has to be paid every 5 years to retain its validity.
Pharmadocx Consultants: Your trusted CDSCO IVD regulatory consultant
We have extensive knowledge of the CDSCO IVD regulatory guidelines. Our team of experts will help you easily obtain the CDSCO license to import IVDs for sale in India. Our comprehensive CDSCO IVD import license application service covers document preparation, application filling, CDSCO query response, and post license support. Additionally, we provide authorised agent service for foreign IVD manufacturers. Drop an email at [email protected] or call/Whatsapp on 9996859227 to partner with our experts.
