Import Authorization for Investigational Devices in Government Hospitals (Forms MD-18, MD-19)
Regulatory Support for Government Hospitals and Statutory Medical InstitutionsIn certain exceptional medical situations, a patient may require an investigational medical device that cannot be imported through the usual import route in India. The Medical Devices Rules, 2017 provide a specific pathway for the import of such devices for patient treatment, subject to the applicable regulatory conditions.
Under Rule 42 of the Medical Devices Rules, 2017, a small quantity of an investigational medical
device may be permitted for import by the Central Licensing Authority (CLA) for the treatment of
an eligible patient.
The regulatory process involves:
Form MD-18 – Application for Import of Investigational Medical Device for Treatment of Patient
Form MD-19 – Licence to Import Investigational Medical Device for Treatment of Patient
This is a specialised regulatory pathway intended for patient-specific treatment requirements and is distinct from a regular commercial import licence for medical devices.
When is the MD-18 / MD-19 Route Applicable?
The MD-18 and MD-19 pathway may be applicable where the conditions specified under Rule 42 of the Medical Devices Rules, 2017 are fulfilled.
The provision covers the import of a small quantity of an investigational medical device where:
- The import of the investigational medical device is otherwise not allowed.
- The device is approved in the country of origin.
- The device is required for the treatment of a patient.
- The patient is suffering from a life-threatening disease; or
- The patient is suffering from a disease causing serious permanent disability; or
- The patient requires therapy for an unmet medical need.
The import permission is considered by the Central Licensing Authority based on the application, supporting documents and applicable regulatory requirements.
Who Can Apply?
Under Rule 42, the application is made by a Medical Officer through the appropriate eligible institution.
Government Hospital
A Medical Officer may apply through the Medical Superintendent of a Government hospital for the import of an eligible investigational medical device required for patient treatment.
Statutory Medical Institution
The regulatory pathway is also available through a statutory medical institution, subject to fulfilment of the applicable requirements.
The application is required to be made in Form MD-18 and accompanied by the prescribed documents and applicable fee.
MD-18 & MD-19 Regulatory Process
The process can generally be understood as follows:
Step 1 – Identify the Patient's Treatment Requirement
The treating Medical Officer identifies the patient's clinical requirement and assesses the need for the investigational medical device.
The application should establish the relevance of the proposed device to the patient's treatment and the applicable condition under Rule 42.
Step 2 – Review the Eligibility of the Device
Before initiating the application, the proposed device should be assessed against the
applicable regulatory requirements.
Key considerations include:
• Whether the product qualifies as an investigational medical device.
• Whether its import is otherwise not allowed in India.
• Whether the device is approved in the country of origin.
• Whether the device is required for treatment of an eligible patient.
• Whether the proposed quantity is appropriate for the patient's treatment requirement.
Step 3 – Prepare the Medical Justification
The application should be supported by appropriate medical information demonstrating the
patient's treatment requirement.
Depending on the case, relevant information may include:
• Patient's disease or diagnosis.
• Nature and seriousness of the medical condition.
• Medical requirement for the proposed device.
• Reason for requiring the investigational medical device.
• Treatment objective.
• Quantity required for the patient's treatment.
The medical justification should be consistent with the information submitted in Form
MD-18 and the supporting institutional documentation.
Step 4 – Collect Device and Manufacturer Information
Relevant information concerning the proposed investigational medical device should be
compiled for the application.
This may include:
• Name of the medical device.
• Description of the device.
• Intended use.
• Name and address of the overseas manufacturer.
• Country of origin.
• Proposed quantity for import.
• Product information and technical details, where relevant.
• Product labelling and Instructions for Use, where applicable.
• Evidence demonstrating approval of the device in the country of origin.
Step 5 – Prepare Form MD-18 and Supporting Documents
The application is made in Form MD-18 and should be accompanied by the documents and fee
specified under the applicable regulatory requirements.
The documentation package should be reviewed for:
• Accuracy of applicant details.
• Correct hospital or statutory institution information.
• Consistency of patient-related information.
• Correct device and manufacturer details.
• Appropriate regulatory evidence.
• Quantity requirement.
• Completeness of supporting documentation.
Additional information or documents may be required depending on the specific facts of
the application and the review by the Central Licensing Authority.
Step 6 – Submit the Application
The completed application in Form MD-18, along with the applicable supporting documents
and fee, is submitted to the Central Licensing Authority through the applicable
regulatory submission process.
Careful review before submission is important to ensure consistency between the medical
requirement, device information, manufacturer details and supporting records.
Step 7 – Review by the Central Licensing Authority
Upon receipt of the application, the Central Licensing Authority reviews the information and documents submitted with the application.
Where the Central Licensing Authority is satisfied with the information and documents, an import licence for the treatment of the patient may be granted in Form MD-19.
The review may involve examination of the relevant medical, institutional and device-related information submitted in support of the application.
Step 8 – Determination of Quantity
Under Rule 42, the quantity considered necessary is determined by the Central Licensing
Authority after taking into account the recommendation of the concerned
hospital.
The quantity determination relates to the treatment requirement of the patient suffering
from:
• A life-threatening disease;
• A disease causing serious permanent disability; or
• A disease requiring therapy for an unmet medical need.
In exceptional and special circumstances, the Central Licensing Authority may allow the
import of a larger quantity of medical devices for use by the patient, where it is
satisfied that such permission is appropriate.
Step 9 – Grant of Licence in Form MD-19
Where the Central Licensing Authority is satisfied with the application and accompanying
information and documents, an import licence may be granted in Form MD-19.
The licence identifies the relevant:
• Medical Officer and institution.
• Overseas manufacturer.
• Medical device.
• Quantity permitted for import.
• Disease or treatment purpose.
As prescribed in Form MD-19, the licence remains in force for one year from the date of
issue, unless previously suspended or revoked.
Step 10 – Import of the Approved Device
Following the grant of the licence, the authorised institution may import the medical device in accordance with the quantity and conditions permitted under the licence and applicable regulatory requirements.
Use of the Investigational Medical Device
A medical device imported under the licence granted pursuant to Rule 42 must be used exclusively for the treatment of the patient for whom the regulatory permission has been granted.
This pathway should therefore not be considered a route for general commercial import, routine distribution or unrestricted use of the investigational medical device.
Record Maintenance Requirements
The holder of the licence is required to maintain records containing:
- Name of the manufacturer.
- Quantity imported and used.
- Date of import.
- Name and address of the patient.
- Diagnosis.
Proper maintenance of these records is an important compliance requirement under Rule 42.
Inspection and Regulatory Oversight
The licence holder is required to allow a Medical Device Officer authorised by the Central Licensing Authority to enter the premises where the medical devices are stocked.
Such authorised officer may inspect:
- The premises where the device is stored.
- Relevant records.
- The manner in which the medical device is being used.
The authorised officer may also investigate the use of the device and take samples where required, in accordance with the applicable provisions.
Documents and Information for MD-18 Application
The exact documentation requirement should be assessed based on the individual application and applicable regulatory requirements. Depending on the case, the application package may involve:
| Sr. No. | Document / Information |
|---|---|
| 1 | Form MD-18 |
| 2 | Medical Officer Details |
| 3 | Government Hospital / Statutory Medical Institution Details |
| 4 | Patient Treatment Requirement |
| 5 | Disease / Diagnosis Details |
| 6 | Medical Justification |
| 7 | Investigational Medical Device Details |
| 8 | Overseas Manufacturer Details |
| 9 | Country of Origin Information |
| 10 | Proposed Import Quantity |
| 11 | Evidence of Approval in Country of Origin |
| 12 | Relevant Product Information |
| 13 | Supporting Hospital Documentation |
| 14 | Applicable Fee |
| 15 | Additional Documents or Information, if Required by the Central Licensing Authority |
How MDR Consultants Can Help
MDR Consultants provides regulatory and documentation support for companies seeking to understand and navigate the CDSCO pathway for medical devices without a predicate device.
- Regulatory Pathway Assessment: We assist in assessing the proposed device, intended use and available regulatory information to help identify the applicable regulatory pathway.
- Predicate Device Assessment Support: Our team can assist in organising the information required for evaluating the availability and relevance of a predicate medical device.
- Regulatory Strategy Development: We help develop a structured regulatory approach based on the nature of the device, classification, intended use and available supporting evidence.
- Technical Documentation Support: We assist in organising and reviewing technical documentation required to support the regulatory application.
- Safety and Performance Documentation: Support may be provided in structuring available testing, validation and performance information for regulatory submission.
- Risk Management Documentation Support: We assist with the organisation and review of risk management documentation relevant to the proposed device.
- QMS Documentation Review: Our team can support the review and organisation of relevant quality management system documentation.
- MD-26 Application Support: We assist with the preparation and coordination of information required for the Form MD-26 application.
- CDSCO Submission Support: Support is provided for organising the regulatory dossier and navigating the applicable CDSCO submission process.
- Regulatory Query Management: Where CDSCO requests clarification or additional information, we assist in reviewing queries and coordinating structured responses.
MDR Consultants – MD-26 & MD-27 Regulatory Support
MDR Consultants provides professional regulatory consulting support for medical device manufacturers and eligible import applicants seeking permission under the MD-26 and MD-27 pathway.
