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- MD-16 and MD-17 allows testing, evaluation, or clinical trials of medical devices in India but not commercial sale.
- Manufacturers or importers submit Form MD-16 via CDSCO portal, and approval grants Form MD-17 license.
- MD-17 is device-specific, usually valid for 2–3 years, renewable or extendable, and limited to approved quantities.
- License holders are obligated to conduct tests, maintain documentation, label the device (or devices) “For Testing Purposes Only – Not for Sale” and report any updates or the occurrence of an adverse event.
- If a device is used by a person or associated with a person’s use without physician licensure or for purposes inconsistent with the license (for example, outside the scope of the test or tests), the individual could be subject to fines, imprisonment, cancellation of any licenses, and seizure of any device or devices that have been subjected to any form of testing.
Introduction
In India’s evolving health care environment, new and exciting medical devices can have a leg up if they have been thoroughly assessed and tested before commercial sale is permitted. Hence, it is important to consider a medical device test license by way of the Central Drugs Standard Control Organization (CDSCO), specifically MD-16 and MD-17.
We are providing this comprehensive guide to discuss what anyone needs to know about obtaining a test license for medical devices in India from the application process through to the regulatory compliance associated with it.
What is a Medical Device Test License?
A medical device test license is an exclusive regulatory grant from CDSCO that permits manufacturers and registrants to manufacture, or import medical devices, in small quantities, for testing, evaluation, clinical investigation, for demonstrative purposes, for education or training purposes, but not for sale.
A test license conveys assurances that the medical devices have been accurately tested and confirmed prior to public use, hence assuring patient safety in its pre-market evaluation process of the medical device before its pre-market distribution of use.
Key Characteristics of Test License
Purpose-Specific Authorization:
- Limited to testing and evaluation activities only
- Cannot be used for commercial sale or distribution
- Restricted to specified quantities
- Device-specific permissions
Regulatory Oversight:
- Issued by CDSCO under Medical Device Rules, 2017
- Subject to strict compliance requirements
- Monitored through periodic reporting
- Requires detailed documentation
Duration and Scope:
- Typically valid for 2-3 years
- Limited to specific medical devices listed in application
- Renewable upon expiry with proper justification
- May be extended for ongoing studies
Understanding Form MD-16: The Application for Test License
Form MD-16 is the official application form used by manufacturers and importers to request permission for testing medical devices in India. This form serves as the initial step in obtaining authorization to manufacture or import medical devices in small quantities for non-commercial purposes.
When is Form MD-16 Required?
You need to submit Form MD-16 if you plan to:
- Import medical devices for testing: Bringing devices from overseas for evaluation, clinical trials, or performance testing
- Manufacture test samples: Producing limited quantities domestically for research and development
- Conduct clinical investigations: Testing devices on human subjects under controlled conditions
- Product demonstrations: Showcasing device functionality to healthcare professionals
- Training purposes: Using devices for educational and training programs
- Performance evaluation: Testing device specifications and functionality
- Validation studies: Conducting technical and clinical validation before commercial launch
Key Components of Form MD-16
The Form MD-16 application requires comprehensive information including:
Applicant Details:
- Name and address of the manufacturer/importer
- Company registration details
- Contact information
- Authorized representative details
- GST registration number
Device Information:
- Medical device name and model
- Device classification (Class A, B, C, or D)
- Intended use and indications
- Technical specifications
- Quantity required for testing
- Duration of testing period
Purpose Declaration:
- Specific purpose of testing (clinical trial, evaluation, demonstration)
- Testing protocol and methodology
- Expected outcomes
- Timeline for completion
- Testing facility details
Supporting Documentation:
- Technical literature and device description
- Manufacturing process details
- Quality management system certificates
- Risk analysis documentation
- Testing facility approvals
Understanding Form MD-17: The Test License Certificate
Form MD-17 is the actual test license certificate issued by CDSCO after approval of the Form MD-16 application. This document grants legal authorization to import or manufacture medical devices for the specific testing purposes mentioned in the application.
Nature of Form MD-17 License
Form MD-17 is the license document that follows when Form MD-16 is accepted, allowing the manufacturer or importer to import or make the devices that appear in Form MD-16.
Authorization Granted:
- Permission to import specified quantity of devices
- Or permission to manufacture limited test samples
- For testing, evaluation, clinical investigation, demonstration, or training
- Under specified conditions and timelines
- Subject to regulatory compliance
Legal Status:
- Legally binding document
- Must be available during customs clearance
- Required for device storage and usage
- Subject to inspection by drug authorities
- Non-transferable authorization
Validity Period of Form MD-17
The MD-17 test license is typically valid for:
- Initial validity: 2-3 years from date of issue
- Extension possible: Upon request with proper justification
- Renewal required: Before expiry for ongoing studies
- Device-specific: Each device listed has its own validity
Who Needs Form MD-16 and MD-17 Test License?
- Manufacturers: Domestic manufacturers creating or modifying devices, validating processes, completing quality testing, or demonstrating devices; international companies testing devices in India or leading multi-country studies.
- Importers & Testing Labs: Independent testing laboratories, quality control labs, calibration/testing labs, and research institutions that import devices for testing or use.
- Clinical Research Organizations: Contract research organizations and research hospitals conducting clinical trials, post-market studies, or safety evaluations of the device.
- Healthcare Institutions: Hospitals, medical colleges, and educational/research institutions that use devices for evaluation, training, or clinical studies.
- Distributors & Agents: Authorized agents, distributors, sales teams, and marketing teams that demonstrate or conduct testing with devices.
Step-by-Step Process to Obtain MD-17 Test License
- Assemble Documentation: Assemble legal (incorporation, GST, PAN, board resolution), technical (description, specifications, design, manufacture), quality/compliance (ISO 13485, CE/FDA, risk analysis), testing protocol (study design, sample size, timeline, ethics approval), and facility documents (lab accreditation, storage, SOPs, equipment calibration).
- Pull together documentation: Collect materials (boilerplate documents, publications, etc.) on topics of interest. Decide on judging procedures (who, how, what condition). Notify participants and/or institutions and test your methodology and materials.
- Upload MD-16: Register on the CDSCO portal, fill out the completed application online with your device information, quantity, rationale for testing, information on the facility, and upload all underlying documents. Review the application and your documentation for completeness before submitting the application.
- Pay Government Fees: Fees are between ₹7,000 and ₹10,000 per device based on classification. Fees can be paid online , net banking, UPI, or through a demand draft.
- Submit Application & Tracking: Submit Form MD-16 through online submission (receipt must be downloaded), receive acknowledgment number, and save all documents.
- CDSCO Scrutiny: The officials will examine, completeness of application, technical details, -testing protocols, whether the device is classified appropriately, safety, adequate facilities, and regulatory compliance.
- Query Resolution/response: Respond to CDSCO queries (typically 15-30 days) and provide clarifications; provide additional documents, and address concerns about methodology, appropriateness of specifications, materials qty, facility capability, or ethics approval at the site.
- Facility inspection (If the device is deemed high risk): In the case of devices determined to be high risk or as part of the clinical trial, CDSCO inspection might be performed in labs or storage; labs must be set up, documents organized, with trained staff available to demonstrate equipment.
- Approval & MD-17 Issuance: Upon successful evaluation, MD-17 license will be issued, which will contain a unique number, license validity (typically 2-3 years), devices or quantities approved, conditions of approval, and how to renewal.
Required Documents for Form MD-16 Application
Company and Legal Documents
1. Company and Legal: Registration/incorporation, PAN, GST, signatory ID, board resolution, authorization letters, bank information.
2. Device Information: Description, intended use, specifications, materials, design, technical manuals, brochures, safety information.
3. Manufacturing and Quality: Process flow, quality control procedures, facility information, good manufacturing practices, ISO 13485, CE/FDA/other certifications, certificate of analysis.
4. Testing and Research: Study protocol, methodology, sample size, statistical plan, clinical trial documents, risk assessment, performance validation, calibration records.
5. Facility and Staff: Lab layout, accreditations, equipment list, standard operating procedures, storage conditions, security, qualifications of staff, good clinical practices/training certificates.
6. Regulatory and Compliance: Free sale/export certificates, approvals from regulatory authorities, patents, labeling, instructions for use, warnings, storage/expiry information, declarations.
7. Import Specific (if applicable): Import license, invoice, bill of lading, packing list, certificate of origin.
8. Clinical Trial (if applicable): CTRI registration, insurance, site approval, handling of samples, plan for reporting adverse events.
Validity and Renewal of MD-17 Test License
License Validity Period
The MD-17 test license is typically valid for:
- Standard validity: 2-3 years from date of issue
- Clinical trials: Duration of approved trial period
- Demonstration purposes: 1-2 years
- Training purposes: 1-2 years
- Device-specific: Based on testing requirements
Renewal Process
To renew your MD-17 test license before expiry:
Step 1: Prepare Renewal Application
- Update testing progress report
- Justify continued need for test license
- Provide data collected during testing period
- Document any device modifications
- Update safety and performance information
Step 2: Submit Renewal Request
- Apply through CDSCO portal
- Upload updated documents
- Pay renewal fees
- Submit within 90 days before expiry
Step 3: CDSCO Review
- Evaluation of testing progress
- Assessment of continued need
- Review of safety data collected
- Verification of compliance with original approval
Step 4: Renewed License Issuance
- Approval for extended period
- Updated MD-17 certificate
- New validity dates
- Revised conditions (if any)
Extension of Test License
If testing cannot be completed within validity period:
- Submit extension request with justification
- Explain reasons for delay
- Provide interim testing results
- Update timeline for completion
- Pay extension fees
Conditions and Restrictions of MD-17 License
- Permitted: Testing, evaluation, clinical trials, demonstrations, training, R&D, performance validation.
- Prohibited: Commercial sale, retail distribution, advertising, routine hospital use, transfer to unauthorized parties, export.
- Quantity Limits: Only approved amounts; excess requires separate approval; unused devices must be returned or destroyed; periodic stock reporting required.
- Compliance: Maintain testing records, device logs, adverse event reports, study progress, and stock registers. Submit quarterly, annual, and final reports to CDSCO. Monitor device performance, ensure subject safety, report serious events, and implement corrective actions.
Difference Between MD-16 and MD-17
| Aspect | Form MD-16 | Form MD-17 |
| Nature | Application form | License certificate |
| Purpose | Request test permission | Grant test authorization |
| Submitted by | Applicant (manufacturer/importer) | Issued by CDSCO |
| Stage | Initial application stage | Final approval stage |
| Content | Detailed device and testing info | License terms and conditions |
| Validity | One-time submission | Valid for 2-3 years |
| Legal Status | Request document | Legally binding authorization |
| Renewal | Not applicable | Renewable before expiry |
Importance of Test License for Medical Device Industry
- Safety & Efficacy: Identify device defects, prove real world safety, keep the patient safe, minimize post market safety issues, and inspire quality confidence.
- Innovation: Create controlled assessment, provide evidence for R&D and clinical validation, stimulate new technology, and create pathways for regulatory approval of new products.
- Regulatory Compliance: Set up effective protocols, use audit trails, maintain adequate documentation, demonstrate compliance, and prepare for commercial licensing.
- Market Readiness: Create clinical evidence, determine user satisfaction, assess market potential, and support product positioning and pricing.
How to Successfully Apply for MD-16 and MD-17:
Before submitting an application: Review Medical Device Rules 2017, read CDSCO guidance, attend workshops, consult experts, and receive updates from industry bodies about device classification for non-Approved Device Investigations. Correctly classify the device; justify classification in writing if required. Work with stakeholders to prepare a testing protocol that has a strong manufacturing and testing methodology, clearly defined endpoints, appropriate plans to monitor safety, and acceptable data analysis and reporting.
Facility & team readiness: Make sure the testing facility satisfies the site conditions, have appropriate accreditations, set up infrastructure and equipment, get staff trained on testing, and have quality systems in place.
Submitting an application: Review documentation, and provide complete, accurate, and user-friendly documentation along with supporting certificates. Make sure the documentation has a professional appearance, be diligent about application status after submission, and be prompt with responding to any inquiries, inspections, meetings.
After approval: Do your best to ensure your team follows the testing protocol, keep detailed memos/notes on all testing, have appropriate plans in place for monitoring safety, submit reports in a timely manner, and comply with any requests for ongoing information. Compile data to share with stakeholders, have plans in place for commercialization, have your quality systems in place, and have your marketing strategy established before it is time to present.
Role of Test License in Device Lifecycle & Non-Compliance Risks:
Lifecycle Stages:
- Development: Prototype testing, design validation, performance verification, safety assessment, user feedback.
- Pre-Clinical: Lab and bench testing, animal studies, biocompatibility, electrical safety.
- Clinical Investigation: Human testing, safety and efficacy demonstration, performance and usability evaluation.
- Regulatory Approval: Data compilation, regulatory submission, commercial license application, manufacturing setup, quality system implementation.
Penalties for Non-Compliance:
- Without License: Fines up to ₹10 lakh, imprisonment up to 3 years, device seizure, criminal prosecution, blacklisting, reputational and business loss.
- Violating License Conditions: Commercial sale, exceeding approved quantities, or failure to report adverse events can lead to license cancellation, penalties, legal action, product recall, and civil/criminal liability.
Conclusion
Medical device test licenses in India serve the purpose of ensuring that all medical instruments and devices are safe and perform appropriately before they are marketed. MD-16 and MD-17 forms establish a critical regulatory framework that promotes innovation while ensuring patient safety by giving manufacturers and researchers the opportunity to test their devices in a controlled setting before distribution. These forms outline safety requirements to ensure that devices have no adverse effects on human health, while also allowing clinicians and researchers to study and gather safety data on new interventions and treatments in increased detail.
By adhering to this guide and maintaining regulatory compliance, manufactures of medical devices are permitted to undergo test licensing with confidence. MD-17 test licenses are not merely an exercise in regulatory compliance, they also permit the collection of data, and the demonstration of the safety and efficacy of the device, paving the way for commercial success in a robust and expanding market for medical devices in India.
In summary, test licenses contribute to patient safety, inform and stimulate new innovations, and offer assurance that medical devices in India are planned and marketed legally. Test licenses reward the journey of innovators and healthcare professionals with healthy and effective safe intervention—as an advancement for healthcare innovation.
Ready to obtain your medical device test license? Start your Form MD-16 application today through the CDSCO portal and take the first step toward bringing your innovative medical device to India’s healthcare market!
Frequently Asked Questions
What is Form MD-16?
Form MD-16 is an application submitted to CDSCO for authorization to manufacture or import medical devices for testing or evaluation within India.
What is Form MD-17?
Form MD-17 is the authorization received from CDSCO after the approval of MD-16, which allows limited testing, evaluation, or clinical use of medical devices—not for sale.
Who needs an MD-16/MD-17 license?
Manufacturers, importers, research institutions, and clinical organizations who will run tests on a medical device prior to the device receiving market authorization.
How long is the MD-17 license valid?
MD-17 licenses are valid 2-3 years, depending on the device and intent of testing; they may also be renewed or extended.
Can MD-17 devices be sold commercially?
No. The devices that have MD-17 authorization or approval can only be sold and used for testing with labeling stating "For Testing Purposes Only - Not for Sale".
What are the penalties for non-compliance?
The penalties include fines up to ₹10 lakh, imprisonment up to 3 years, cancellation of license, and confiscation or seizure of the device.
