License to Import Medical Devices for Clinical investigation/ Test/ Evaluation/ Demo/ Training (MD-16 & MD-17)

Before an In Vitro Diagnostic (IVD) medical device can be commercially launched in India, manufacturers and importers often need to bring in limited quantities for essential non-commercial purposes. These crucial activities include clinical investigations, testing, evaluation, demonstration, or training. The Central Drugs Standard Control Organization (CDSCO) meticulously regulates this  process  through Forms MD-16 (Application) and MD-17 (License).

Obtaining this “Test License” is a vital step, ensuring that critical pre-market activities for your IVD devices are conducted compliantly and effectively within India.Understanding Forms MD-16 & MD-17

These forms are central to legally importing IVD medical devices for non-commercial uses:

·    Form MD-16: Application for License to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training.

o   This is the application form submitted by an importer or manufacturer to the Central Licensing Authority (CLA) under CDSCO.

o   It requires detailed information about the specific IVD medical device(s) to be imported, the exact quantity, and the precise non-commercial purpose (e.g., a specific clinical study, performance evaluation, or training program).

·         Form MD-17: License to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training.

o   This is the official license issued by the CDSCO once the Form MD-16 application is approved.

o   Form MD-17 grants the legal permission to import the specified IVD medical devices in limited quantities solely for the stated non-commercial purposes. It’s crucial to understand that devices imported under this license cannot be sold or distributed commercially.

·       This license is typically valid for three years from its date of issuance.

Why Are Forms MD-16 & MD-17 Indispensable?

These forms are paramount for both medical device companies and their consulting partners as they facilitate critical pre-market activities in India:

• Enabling Essential R&D: For novel IVDs or those new to the Indian market, a test license is indispensable for conducting clinical investigations and performance evaluations. This generates vital data tailored to the Indian population and local regulatory requirements.
• Facilitating Product Adaptation: Manufacturers can leverage this license to perform testing and evaluation, allowing them to adapt their IVDs to India’s unique healthcare conditions or integrate them seamlessly into existing systems.
• Supporting Training & Demonstration: The license permits the import of IVDs for training healthcare professionals on their proper use or demonstrating their functionalities, which is crucial for successful market adoption and safe application.
• Ensuring Regulatory Compliance: Importing IVDs without the appropriate test license, even for non-commercial purposes, is a serious regulatory violation. MD-16/17 ensures adherence to the Medical Devices Rules, 2017, helping you avoid penalties.
• Strategic Market Entry: For our clients, securing this license is a strategic move, laying the groundwork for eventual commercialization by enabling necessary preliminary steps in a compliant manner.

Who Can Apply for an IVD Test License?

Any individual or entity in India planning to import a small quantity of IVD medical devices (regardless of classification: Class A, B, C, or D) for clinical investigations, testing, evaluation, demonstration, or training purposes, can apply. This typically includes:

• Indian Importers: Companies with a valid import license or those specifically seeking to import for these non-commercial uses.
• Indian Manufacturers: Who may need to import components or finished IVDs for in-house testing or R&D purposes.
• Clinical Research Organizations (CROs): Entities conducting clinical investigations on behalf of manufacturers.
• Educational or Research Institutions: For academic teaching or scientific research.

The Test License Application Process (Forms MD-16, MD-17)

The application for a test license is conducted online through the CDSCO’s Sugam portal. The process generally includes these key steps:

1. Sugam Portal Registration:

The applicant (importer or authorized agent) must first be registered on the CDSCO’s online portal to access the application system.

2. Application in Form MD-16:

The application is diligently filled out online, requiring precise details about the IVD device, the proposed quantity, and the specific non-commercial purpose of import (e.g., for a clinical investigation plan, specific testing parameters, evaluation criteria, or a detailed training module).

3. Comprehensive Document Preparation:

A robust set of documents must be compiled and uploaded. This typically includes:

• Covering Letter: Clearly stating the objective and purpose of the test license application.
• Brief IVD Description: Providing an overview of the device, its intended use, materials of construction, design principles, and operating mechanism.
• Justification of Quantity: A clear and well-reasoned rationale for the exact quantity of devices proposed for import, including a utilization breakdown (e.g., how many for testing, how many for training, how many for retention/disposal).
• Test Protocol/Approved Clinical Investigation Plan: If the purpose involves testing or a clinical investigation, a detailed protocol or an approved clinical investigation plan must be submitted. For certain diagnostic kits, a mandatory performance evaluation from institutions.
• Quality Certificates: Evidence of the manufacturer’s robust Quality Management System (QMS), such as ISO 13485 certification.
• Labels and Instructions for Use (IFU): Compliant with Rule 48 of the Medical Devices Rules, 2017.
• Undertaking: A solemn declaration stating that the IVD will be used exclusively for the specified non-commercial purpose and will not be used for commercial sale or distribution.
• Undertaking from Testing Facility (if applicable): Confirmation from the designated testing laboratory affirming it possesses the necessary facilities, equipment, instruments, and qualified personnel.
• Fee Challan: Proof of payment of the prescribed government fee (currently USD 100 per distinct device).
• Legal Documents: Any other legal forms or documents as required by CDSCO.

4. Online Submission & Fee Payment:

The completed Form MD-16 application and all supporting documents are submitted electronically, along with the payment of the prescribed fees.

5. CDSCO Review:

The Central Licensing Authority (CLA) meticulously reviews the application and submitted documentation. They may raise queries or request additional information, which must be addressed promptly and comprehensively.

6. Grant of License (Form MD-17):

If the application meets all regulatory requirements and the CDSCO is satisfied, the test license will be officially granted in Form MD-17.

7. Mandatory Record Keeping:

The MD-17 license holder is obligated to maintain detailed records of all activities related to the imported devices. This includes manufacturer details, imported quantity, import date, how the devices were utilized, and (if unused) how they were disposed of or exported with prior intimation to CDSCO. This ensures accountability and adherence to the license’s terms.

Why Engage an MDR Consultant for MD-16 & MD-17 Permissions?

The process of obtaining a test license is intricate and requires precise adherence to regulatory guidelines. Engaging an MDR consultant offers significant advantages, streamlining the entire journey:

• Deep Regulatory Expertise: Our consultants possess an in-depth understanding of the Medical Devices Rules, 2017, and the specific nuances for IVDs, ensuring your application perfectly aligns with CDSCO’s expectations.
• Efficient Document Preparation: We guide you through the meticulous process of compiling the required dossier, ensuring all documents are accurate, complete, and in the correct format, significantly minimizing the chances of rejection or queries.
• Strategic Planning: We help you strategically justify the quantity of devices to be imported and assist in optimizing your clinical investigation or evaluation plan, paving the way for faster approval.
• Seamless Online Portal Navigation: Our team is proficient in using the Sugam online portal, guaranteeing smooth submission and efficient handling of all online processes.
• Effective Query Management: We can effectively interpret and respond to any queries raised by CDSCO, expediting the review process and preventing unnecessary delays.
• Timely Approval: By ensuring a robust, accurate, and compliant application, we significantly increase the likelihood of obtaining your test license within the shortest possible timeframe.
• Focus on Your Core Business: Partnering with us allows you to concentrate on your primary R&D, manufacturing, or business development activities, confident that the complex regulatory aspects are expertly managed.

Ready to import IVD medical devices for essential testing, evaluation, or training in India?

Contact an MDR consultant today! We offer a free consultation to discuss your specific IVD device, outline the precise requirements for Forms MD-16 and MD-17, and guide you through the entire application process, ensuring a compliant and efficient path to obtaining your test license.