Importing medical devices for testing purposes is a regulated process. Central Drugs Standard Control Organization (CDSCO) is the apex medical device regulatory body and oversees all medical devices being imported into India. Devices imported for testing, evaluation, or clinical investigation require prior permission from CDSCO. Notably, devices specifically imported for testing purpose cannot be sold commercially in India. The import license for testing medical devices in India is Form MD 17. Form MD 17 grants the permission for importing small quantities of medical devices for testing, evaluation, clinical investigations, demonstration, or training purposes. We have prepared a detailed guide on securing CDSCO import test license for importing small quantities of medical devices.
What is CDSCO MD 17 license or Form MD17?
CDSCO MD 17 license or Form MD17 is the import license for testing medical devices in India. CDSCO MD-17 license is a special import permit issued by Central Drugs Standard Control Organization that allows companies or institutions to import small quantities of medical devices into the country specifically for testing purposes. Unlike commercial import licenses, the MD-17 is restricted to non-commercial purposes, meaning the imported devices cannot be sold or marketed. It ensures that regulators can oversee the entry of limited quantities of devices for generating local performance and safety data, conducting trials, or training healthcare professionals, while maintaining strict controls on traceability and usage. CDSCO MD 17 license permits the import of medical devices for:
- Clinical investigations
- Tests and evaluations
- Demonstrations
- Training purposes
The need for importing medical devices for testing in India
- Regulatory compliance: India’s CDSCO requires performance and safety data before granting full commercial market approval. Hence, securing the import license for testing medical devices is important to collect the necessary performance and safety data. Imported samples allow accredited labs and institutions in India to conduct independent verification of claims made by manufacturers. This ensures that every imported medical device meets Indian standards and are safe for patients before commercialization.
- Clinical investigations: For higher-risk devices (e.g., implants, diagnostic equipment), clinical trials or performance evaluations must be conducted locally. Importing test samples enables hospitals and research centers to generate India-specific data, which regulators prioritize.
- Technology assessment: India often evaluates devices developed abroad to determine their suitability for local healthcare needs. Importing devices for testing purposes helps assess adaptability to Indian conditions (infrastructure, patient demographics, disease patterns).
- Capacity building: Imported samples are used for training and demonstration in medical colleges, labs, and hospitals. This builds competence among healthcare professionals before devices are widely deployed.
- Market entry strategy: Global manufacturers import limited quantities for evaluation by key opinion leaders and institutional buyers. Positive testing outcomes support regulatory submissions and commercial launch.
CDSCO import license for testing medical devices
An importer or manufacturer who intends to bring a limited quantity of Class A, B, C, or D medical devices into India for non-commercial purposes can apply for a CDSCO import license for testing medical devices (Form MD-17). This CDSCO import test license authorizes the import of small quantities of devices solely for testing, evaluation, demonstration, or training activities. CDSCO is the regulatory authority responsible for granting the CDSCO MD-17 license. To obtain it, applicants must submit Form MD-16 via the online Sugam portal. Additionally, the required documents and applicable fees have to be submitted. Then, CDSCO will review the application and issue the MD-17 license.
- Form MD-16: Form MD-16 is the application form for applying for CDSCO import license for testing medical devices (Form MD-17).
- Form MD-17: CDSCO grants the permission for importing small quantities of medical devices for testing purposes in India on Form MD-17. The medical devices can be imported for activities, such as testing, evaluation, training, or conducting clinical investigation, as specified in the license.
Pro tips for CDSCO MD 17 license application
The applicant must follow these essential requirements:
- The applicant is required to specify the quantity of medical devices to be imported during the application submission.
- The device’s batch details, quantity to be utilized, and amount to be retained has to be justified during the submission.
- The name of the place where testing, demonstration, evaluation, or training will be performed has to be mentioned during the submission.
- If the CDSCO import test license is required for clinical investigation, the protocol of the clinical trials has to be provided in the application file.
Documents required for CDSCO import license for testing medical devices
- Applicant identification: Aadhaar card or PAN card of the authorized signatory.
- Product technical details: Detailed description of the medical device, including its intended use, design, and material of construction.
- Manufacturing quality documents: Quality Management System (QMS) certificates (ISO 13485) and, in some cases, the manufacturing license.
- Quantity justification: A detailed justification for the specific quantity of devices proposed to be imported.
- Test protocol: Approved testing protocol, evaluation plan, or clinical investigation plan if the device is for testing on human subjects.
- Labels and IFU: Sample labels and Instructions for Use (IFU).
- Device master file: Technical documentation, manufacturing process details, and risk analysis documentation.
- Location details: Name and address of the laboratory or facility where the devices will be tested, evaluated, or used for training.
- Declaration of conformity: A declaration of conformity issued by the manufacturer.
8-step guide to obtain CDSCO import license for testing medical devices (MD 17)
- Prepare documentation: Prepare the necessary supporting documentation covering device details (name, model, intended use), manufacturer’s authorization letter, testing/evaluation protocol or purpose statement, undertaking for non-commercial use, and any relevant quality certificates.
- Access the online portal: Log in to or create an account on the SUGAM portal (CDSCO’s official online application system).
- Submit application form: File the application for CDSCO import license for testing medical devices on Form MD-16. Upload all required documents in the prescribed format.
- Pay applicable fees: Pay the prescribed fee electronically through the portal.
- Regulatory review: CDSCO reviews the application, documents, and justification for import. Queries or clarifications may be raised during this stage. It is important to promptly and accurately respond to CDSCO queries.
- Grant of license: Upon approval, CDSCO issues the MD-17 import test license. This authorizes import of the specified quantity of devices for the stated purpose.
- Usage of license: The imported devices can only be used for the specific purposes mentioned (testing, demonstration, clinical investigations, or training) in the license and must be used at the locations specified in the license.
- Post-import obligations: Maintain records of usage, testing, demonstration, or training. Ensure devices are not sold commercially. Dispose of or return samples as per regulatory requirements.
Validity of CDSCO import test license
The CDSCO import license for testing medical devices remains valid for a period of 3 years.
Fees for CDSCO MD 17 license
A fee of 100 USD is required per product for obtaining a medical device import test license in Form MD-17.
Key obligations for CDSCO MD 17 license
- The import shipment must be accompanied by an invoice or statement indicating the name and quantity of the medical device.
- The license holder is required to maintain detailed records of all activities, including information about the manufacturer, quantity imported, and import date.
- Unused devices may be exported or destroyed. However, prior intimation to the Central Licensing Authority is required.
How can Pharmadocx Consultants help you obtain CDSCO import license for testing medical devices?
We provide comprehensive CDSCO MD 17 license application support. Our service covers:
- Document preparation
- License application and filling
- CDSCO query response
- Post license support
- License renewal support
To easily secure CDSCO import license for testing medical devices, email at [email protected] or call/Whatsapp on 9996859227.
