Personal Use Medical Device Import License (Forms MD-20, MD-21)
CDSCO Permission for Import of Small Quantities of Medical Devices for Personal UseIn certain situations, an individual may need to import a medical device into India for bona fide personal use. Where the medical device is not forming part of bona fide personal baggage and the applicable conditions are met, the Medical Devices Rules, 2017 provide a regulatory pathway for obtaining permission from the Central Licensing Authority (CLA).
The application for this pathway is made in Form MD-20, and permission may be granted in Form MD-21.
This route is intended for the import of a small quantity of a medical device for bona fide personal use and should not be considered a commercial import licensing pathway.
In Simple Terms
MD-20 = Application for Permission to Import a Small Quantity of Medical Devices for Personal Use
MD-21 = Permission to Import the Approved Medical Device for Personal Use
MDR Consultants provides regulatory and documentation support to applicants seeking to understand and navigate the applicable CDSCO requirements for personal-use medical device imports.
What Are Form MD-20 and Form MD-21?
Form MD-20 – Application for Personal Use Import Permission
Form MD-20 is the prescribed application for seeking permission to import a small quantity of a medical device for personal use under the applicable provisions of the Medical Devices Rules, 2017.
The application is relevant where the medical device is intended for bona fide personal use and is not forming part of bona fide personal baggage.
The application must be supported by documents confirming the bona fide personal-use requirement and a prescription from a Registered Medical Practitioner.
Form MD-21 – Permission to Import for Personal Use
Form MD-21 is the permission granted by the Central Licensing Authority for the import of the specified medical device in the approved quantity for personal use.
The permission identifies the approved medical device, manufacturer and quantity permitted for import, subject to the applicable conditions.
When Is MD-20 & MD-21 Permission Required?
Under Rule 43 of the Medical Devices Rules, 2017, a small quantity of a medical device may be imported for personal use under specified conditions.
The MD-20/MD-21 pathway is particularly relevant where:
- A small quantity of a medical device is required for bona fide personal use.
- The device is not forming part of bona fide personal baggage.
- The applicable import conditions under the Medical Devices Rules, 2017 are fulfilled.
- A Registered Medical Practitioner has prescribed the medical device.
- Supporting documents establish the bona fide personal-use requirement.
The applicability of this route should be assessed based on the specific circumstances of the proposed import.
Who May Apply for MD-20 Permission?
The MD-20 pathway may be relevant to an applicant seeking to import a small quantity of a medical device exclusively for bona fide personal use.
Depending on the circumstances, the application may involve:
The information provided in the application should clearly establish the personal-use purpose of the proposed import.
MD-20 & MD-21 Application Process
The process can generally be understood as follows:
Assess the Personal-Use Import Requirement
The first step is to assess whether the proposed import falls within the personal-use provisions under Rule 43 of the Medical Devices Rules, 2017.
Important considerations include:
• Whether the medical device is required for bona fide personal use.
• Whether only a small quantity is proposed for import.
• Whether the device is forming part of bona fide personal baggage.
• Whether the proposed quantity is supported by the prescription.
• Whether the relevant supporting documentation is available.
MD-20/MD-21 should not be treated as a substitute for a commercial medical device import licence.
Obtain a Prescription from a Registered Medical Practitioner
For an MD-20 application, the applicant is required to submit a prescription supporting
the need for the medical device.
The prescription should clearly support the personal requirement for the proposed
device and quantity.
Depending on the medical requirement, supporting documentation may help establish:
• Patient details.
• Medical requirement.
• Name or identification of the required medical device.
• Required quantity.
• Duration or frequency of use, where relevant.
The quantity proposed for import should remain consistent with the genuine personal requirement and supporting medical documentation.
Prepare Supporting Documentation
The application must be accompanied by documents confirming that the medical device is intended for bona fide personal use and a prescription from a Registered Medical Practitioner.
Depending on the information required in the applicable CDSCO application system and the specific case, supporting documentation may include:
| Sr. No. | Document / Information |
|---|---|
| 1 | Prescription from a Registered Medical Practitioner |
| 2 | Patient Details |
| 3 | Patient Identity Proof, as applicable |
| 4 | Details of Person Collecting the Consignment, where applicable |
| 5 | Residential Address and Contact Information |
| 6 | Medical Device Details |
| 7 | Manufacturer Name and Address |
| 8 | Quantity Proposed for Import |
| 9 | Documents Supporting Bona Fide Personal Use |
| 10 | Invoice or Product Value Information, where applicable |
| 11 | Relevant Supporting Medical Documentation, where necessary |
| 12 | Other Documents or Information Required by CDSCO |
Other Documents or Information Required by CDSCO
Prepare the Online MD-20 Application
The applicant prepares the application in Form MD-20 through the applicable CDSCO online
system.
The online application may require information relating to:
• Patient details.
• Applicant details.
• Contact information.
• Residential address.
• Identity proof details.
• Medical device details.
• Manufacturer details.
• Quantity proposed for import.
• Personal-use justification.
• Medical prescription.
• Details of the person collecting the consignment, where applicable.
All information should be reviewed carefully to ensure consistency with the supporting documents.
Submit the MD-20 Application
Once the required information and supporting documents are compiled, the application is
submitted to the Central Licensing Authority through the applicable CDSCO online
system.
Before submission, applicants should verify:
• Accuracy of patient information.
• Correct medical device details.
• Manufacturer information.
• Proposed quantity.
• Validity and relevance of the prescription.
• Availability of documents supporting bona fide personal use.
• Consistency across the application and uploaded documents.
Incomplete or inconsistent information may result in requests for clarification.
CDSCO Review
The Central Licensing Authority reviews the application and supporting documents.
The review may consider whether:
• The application contains the required information.
• The documents support bona fide personal use.
• A prescription from a Registered Medical Practitioner has been provided.
• The medical device and proposed quantity are appropriately identified.
• Additional clarification is required.
Under Rule 43, upon receipt of the application, the Central Licensing Authority may
grant permission in Form MD-21 or reject the application, with reasons recorded in
writing, within the period prescribed under the Rules.
Respond to CDSCO Queries, If Raised
Where CDSCO requests clarification or additional information, the applicant should provide an accurate and complete response.
A response may involve:
• Clarifying the personal-use requirement.
• Providing additional medical documentation.
• Correcting inconsistencies in the application.
• Providing clarification regarding the medical device.
• Submitting additional information requested by the authority.
MDR Consultants can assist clients with understanding regulatory queries and organising appropriate supporting documentation.
Grant of Permission in Form MD-21
Where the Central Licensing Authority is satisfied with the application and supporting documents, permission may be granted in Form MD-21.
The permission specifies the approved medical device and quantity permitted for personal use.
The applicant should carefully review the details and conditions of the permission before proceeding with the import.
Import and Customs Documentation
Following the grant of applicable permission, the approved medical device may be imported in accordance with the conditions of the permission and other applicable requirements.
Under Rule 43, the medical device may be required to be declared to Customs Authorities if directed.
The consignment should be accompanied by an invoice or statement showing:
• Name of the medical device.
• Quantity of the medical device.
Applicants should ensure that the imported consignment corresponds to the approved device and quantity.
MD-20 & MD-21 Processing Timeline
Under Rule 43(3) of the Medical Devices Rules, 2017, the Central Licensing Authority may grant permission in Form MD-21 or reject the application, with reasons recorded in writing, within seven days from the date of application, upon being satisfied with the information and documents submitted.
Actual processing may depend on the completeness and adequacy of the application and any clarification required by the regulatory authority.
Important Conditions for Personal-Use Import
The MD-20/MD-21 pathway is intended specifically for bona fide personal use.
Applicants should keep in mind that:
- The import should relate to a genuine personal-use requirement.
- The pathway is for a small quantity of the medical device.
- A prescription from a Registered Medical Practitioner is required for the MD-20 route.
- Supporting documents should establish bona fide personal use.
- Customs declaration requirements must be complied with where directed.
- The consignment should be accompanied by an invoice or statement showing the device name and quantity.
- The imported device should correspond with the details approved under the applicable permission.
- The route should not be used as a substitute for commercial import licensing.
Proper maintenance of these records is an important compliance requirement under Rule 42.
How MDR Consultants Can Help
MDR Consultants provides regulatory and documentation assistance for applicants seeking to understand the MD-20/MD-21 pathway for personal-use medical device imports.
- Regulatory Applicability Assessment: We help assess the proposed import requirement and review whether the MD-20/MD-21 personal-use pathway may be applicable.
- Documentation Guidance: Our team assists in identifying and organising the documents and information required to support the application.
- MD-20 Application Support: We provide support in preparing and reviewing the information required for the Form MD-20 application.
- Medical Device Information Review: We assist in organising relevant device, manufacturer and quantity information for consistency within the application.
- CDSCO Online Submission Support: MDR Consultants can guide applicants through the applicable CDSCO online submission process.
- Regulatory Query Support: Where clarification or additional information is requested, we assist with reviewing the query and organising an appropriate response.
- Import Permission Support: We provide regulatory support through the application and MD-21 permission stage.
Need Support for MD-20 & MD-21 Personal Use Import Permission?
If you are planning to import a small quantity of a medical device into India for bona fide personal use, MDR Consultants can help you understand the applicable regulatory requirements and documentation process.
