Import License for IVD Devices for Testing & Evaluation (Forms MD-16, MD-17)
CDSCO Test Licence for Import of Medical Devices and IVDs in IndiaMedical device companies may need to import limited quantities of medical devices or in-vitro diagnostic (IVD) medical devices into India before commercial distribution. Such imports may be required for activities including clinical investigation, testing, evaluation, demonstration or training.
Under the Medical Devices Rules, 2017, a specific regulatory pathway is available for importing medical devices and IVDs for these purposes.
The process involves:
Form MD-16 – Application for Licence to Import Medical Devices for Clinical Investigation,
Test, Evaluation, Demonstration or Training
Form MD-17 – Licence to Import Medical Devices for Clinical Investigation, Test, Evaluation,
Demonstration or Training
MDR Consultants provides regulatory and documentation support for organisations seeking to navigate the applicable CDSCO requirements for MD-16 and MD-17 test licences.
In Simple Terms
MD-16 = Application for Import Test Licence
MD-17 = Licence to Import for Approved Non-Commercial Purposes
What Are MD-16 and MD-17?
Form MD-16 – Application for Import Test Licence
Form MD-16 is the prescribed application submitted to the Central Licensing Authority (CLA) for obtaining a licence to import medical devices or IVD medical devices for purposes such as:
- Clinical investigation
- Testing
- Testing
- Demonstration
- Training
The application is accompanied by the prescribed fee and supporting information required under the Medical Devices Rules, 2017.
Form MD-17 – Import Test Licence
Form MD-17 is the licence granted by the Central Licensing Authority when the applicable regulatory requirements are satisfied.
The licence permits the import of the approved medical device or IVD in the quantity determined by the Central Licensing Authority for the specified purpose.
The imported device must be used exclusively for the purpose approved under the licence and should not be diverted for commercial use.
Who Can Apply?
The MD-16 pathway may be relevant to eligible organisations or persons seeking to import medical devices or IVDs for an approved purpose under Rule 40.
Depending on the proposed activity, applicants may include:
- Medical device manufacturers
- Overseas manufacturers through appropriate Indian entities
- Importers
- Authorised representatives
- Clinical Research Organisations
- Testing or evaluation organisations
- Research institutions
- Training organisations
- Other eligible entities involved in the approved activity
The applicant and proposed activity should be assessed against the applicable regulatory requirements before submission.
MD-16 & MD-17 Application Process
The regulatory process can generally be understood as follows:
Assess the Import Requirement
The first step is to determine why the medical device or IVD needs to be imported.
The proposed purpose should fall within the activities permitted under the applicable
provisions, such as:
• Clinical investigation
• Test
• Evaluation
• Demonstration
• Training
A clear regulatory justification should be established before preparing the application.
Define the Device and Proposed Quantity
The applicant should identify the medical device proposed for import and determine the quantity required.
Relevant information may include:
• Generic and brand name
• Model number, where applicable
• Intended use
• Device classification
• Material of construction, where applicable
• Device dimensions, where applicable
• Shelf life
• Sterile or non-sterile status
• Proposed quantity
Under the Medical Devices Rules, 2017, the Central Licensing Authority determines the quantity of medical devices after considering the proposed requirement and supporting information submitted by the applicant.
The quantity justification should therefore clearly explain the proposed utilisation of the imported devices.
Establish the Purpose and Utilisation Plan
The application should clearly explain the purpose for which the medical device is proposed to be imported.
The utilisation plan may include information regarding:
• Nature of testing or evaluation
• Clinical investigation, where applicable
• Demonstration activities
• Training requirements
• Location where the activity will be conducted
• Estimated quantity required
• Duration of the proposed activity
A clear purpose and quantity justification can help ensure consistency across the application and supporting documents.
Prepare Technical Documentation
The applicant should compile relevant information regarding the medical device or
IVD.
Depending on the device and proposed purpose, documentation may include:
• Brief description of the medical device
• Intended use
• Device specifications
• Test specifications
• Testing protocol
• Applicable standards
• Quality management system documentation, where available
• Product labels
• Instructions for Use
• Other relevant technical information
The exact documentation should be aligned with the current CDSCO checklist and the nature of the proposed activity.
Prepare Required Undertakings
Prepare Required Undertakings
Depending on the proposed activity, the applicant may be required to provide an
undertaking confirming that:
• The imported medical device will be used exclusively for the purpose stated in the
application.
• The device will not be used for commercial purposes.
• Appropriate facilities, equipment, instruments and personnel will be available to
conduct testing or evaluation, where applicable.
• Applicable provisions of the Medical Devices Rules, 2017 will be complied with.
These undertakings should accurately reflect the proposed activity.
Prepare Form MD-16 Application
Once the required information and documents are available, the application can be prepared in Form MD-16.
The application includes information relating to:
• Applicant details
• Medical device details
• Manufacturer details
• Purpose of import
• Quantity proposed for import
• Justification for the proposed quantity
• Details of testing or evaluation activities, where applicable
• Required undertakings
• Applicable fee
All information should be reviewed for accuracy and consistency before submission.
Submit the Application to CDSCO
The MD-16 application is submitted through the applicable CDSCO online regulatory system.
The submission should include the prescribed application, supporting documents and applicable government fee.
Before submission, applicants should verify:
• Accuracy of device information
• Manufacturer details
• Purpose of import
• Quantity justification
• Technical documentation
• Labels and IFU
• Applicable standards and test specifications
• Required undertakings
• Fee documentation
Incomplete or inconsistent applications may result in regulatory queries or requests for additional information.
CDSCO Review
The Central Licensing Authority reviews the MD-16 application and supporting documentation.
The review may consider:
• Purpose of the proposed import
• Medical device details
• Quantity justification
• Clinical investigation plan, where applicable
• Testing or evaluation protocol
• Supporting technical documentation
• Proposed place of use
• Required facilities
• Undertakings and declarations
The Central Licensing Authority may conduct further enquiry where considered necessary.
Respond to Regulatory Queries
If CDSCO requests clarification or additional information, the applicant should provide an appropriate and complete response.
Query responses may involve:
• Clarification of the proposed purpose
• Additional quantity justification
• Revision of supporting documentation
• Additional technical information
• Clarification regarding the testing or evaluation activity
• Supporting information regarding facilities or personnel
MDR Consultants can assist with regulatory query analysis, document review and preparation of structured responses.
Grant of MD-17 Import Licence
Where the Central Licensing Authority is satisfied that the applicable requirements have been fulfilled, a test licence may be granted in Form MD-17.
Under Rule 41 of the Medical Devices Rules, 2017, the Central Licensing Authority may grant the licence or reject the application, with reasons recorded in writing, within the prescribed regulatory timeline.
The applicant should review the approved device details, quantity and conditions of the licence before proceeding with import.
Conditions After Grant of MD-17 Licence
Medical devices imported under an MD-17 licence are subject to specific conditions.
• Clinical investigation
• Testing
• Evaluation
• Demonstration
• Training
as applicable to the approved licence.
The device should not be used for commercial sale or distribution.
Where the medical device is required to be taken to another location, the Central Licensing Authority should be informed in writing before doing so, in accordance with the applicable provisions.
Records include information such as:
• Name of the manufacturer
• Quantity imported
• Date of import
• Activities undertaken
Appropriate documentation should be maintained for regulatory accountability.
• Name of the medical device
• Quantity of the medical device
Validity of Form MD-17 Licence
Unless cancelled earlier, a licence granted in Form MD-17 remains valid for three years from the date of issue, subject to compliance with applicable regulatory requirements and licence conditions.
Key Documents for MD-16 Application
Unless cancelled earlier, a licence granted in Form MD-17 remains valid for three years from the date of issue, subject to compliance with applicable regulatory requirements and licence conditions.
How MDR Consultants Can Help
MDR Consultants provides regulatory consulting and documentation support for organisations seeking an MD-17 import test licence.
- Regulatory Applicability Assessment: We assist in understanding the proposed import activity and assessing the applicability of the MD-16/MD-17 pathway.
- Purpose and Quantity Assessment: Our team assists in organising the purpose of import and preparing a structured quantity justification and utilisation plan.
-
Technical Documentation Support:
We help coordinate and organise relevant technical documentation, including:
• Device descriptions
• Test specifications
• Protocols
• Applicable standards
• Labels
• Instructions for Use - MD-16 Application Support: MDR Consultants assists with the preparation and review of information required for the Form MD-16 application.
- Documentation and Undertaking Support: We help identify and organise the applicable declarations, undertakings and supporting documents required for the submission.
- CDSCO Submission Support: Our team provides assistance with the applicable CDSCO online submission process and regulatory dossier organisation.
- Regulatory Query Management: If queries are raised during the review, MDR Consultants assists with query analysis, gap assessment and preparation of appropriate responses.
- MD-17 Licence Support: We provide regulatory support through the application review and MD-17 licence stage.
Need Support for MD-16 & MD-17 Import Test Licence?
From initial regulatory assessment and documentation planning to MD-16 application preparation, CDSCO submission, query management and MD-17 licence support, our team provides structured regulatory assistance throughout the process.
