India - Apply for Medical Device License

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Procedure

Apply Online

1. To Apply for Medical Device License, the applicant has to make the application online via the following link – link
2. The applicant has to click Login/Register button.
3. If the applicant is a new user click “Register here”.
4. Select the registration and click the “Submit” button.
5. The applicant has to enter all the details for registration process.
6. Also, upload all the necessary documents that are mentioned in the “Required Documents” section of this page.
7. Finally enter the captcha code and click the “Submit” button.
8. The applicant has to enter the user id and password with the captcha code and click the “Login” button.
9. After that the applicant has to select the type of application and select the form from the drop-down menu.
10. The applicant has to fill in all the necessary details in the application form.
11. The details that need to fill in are provided in the Required Information section of this page.
12. Then the applicant has to upload all the necessary documents that are mentioned in the “Required Documents” section of this page.
13. Click declaration and read the declaration and click “Submit”.
14. Next the applicant has to make the payment as prescribed and click the “Submit” button.
15. Then the applicant will receive an email regarding the successful submission of the application from the nodal officer.
16. Then it will be forwarded to the reviewing officer. After review the application will be forwarded to Nodal Officer.
17. Then it will be forwarded to other inspection officers. After approval, the authority will issue the license.
18. The committee, after completing their assessment, forwards the opinion regarding device suitability to the competent authority for permission for placing the device on the market.
19. This entire process can be completed within 30 -45 days or as per the timeline advised by the respective department authority.

Apply In-Person:

1. To Apply for Medical Device License, the applicant has to approach the nodal offices of the Central Drugs Standard Control Organization (CDSCO) – link
2. An application form will be provided to the applicant by the concerned officer
3. The applicant has to fill in all the necessary details in the application form. (Incomplete applications are not accepted)
4. Make sure that the applicant has attached all the necessary documents that are mentioned in the “Required Documents” section of this page.
5. The applicant has to attach the photocopies of the required documents along with the application form while submitting.
6. Submit all the documents with the completed form to the concerned officer.
7. The applicant has to pay the prescribed fee as requested by the authority.
8. After receiving the application, the concerned authority will check the submitted application and document set. If all are in place, the application will be accepted.
9. All applications are processed within a reasonable time, regarding the particular circumstances of each application, including the completeness of information and documents submitted to the authority by the applicant.
10. Then it will be forwarded to the reviewing officer. After review the application will be forwarded to Nodal Officer.
11. Then it will be forwarded to other inspection officers. After approval, the authority will issue the license.
12. The committee, after completing their assessment, forwards the opinion regarding device suitability to the competent authority for the purpose of permission for placing the device on the market.
13. This entire process can be completed within 30 -45 days or as per the timeline advised by the respective department authority.

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Required Documents

• Application Form
• Manufacturer's Details: Information about the manufacturer of the medical device, including the company name, address, contact details, and manufacturing license details (if applicable).
• Device Details: Comprehensive details about the medical device, including its name, model, intended use, classification, specifications, and technical documentation.
• Product Information: Detailed product information, such as brochures, catalogs, labeling, and instructions for use (IFU) in English.
• Manufacturing Process: Description of the manufacturing process for the medical device, including information on the materials used, quality control measures, and sterilization methods (if applicable).
• Clinical Data: Clinical data, if required, to establish the safety and performance of the medical device. This may include clinical trial reports, published literature, post-market surveillance data, and adverse event reports.
• Regulatory Approvals: If the medical device has obtained regulatory approvals in other countries, copies of these approvals or certifications may be required.
• Stability Data: Stability data that demonstrates the shelf-life and storage conditions of the medical device.
• Quality Management System: Information about the manufacturer's quality management system, such as ISO certifications or other relevant quality system certifications.
• Test Reports: Test reports from authorized testing laboratories for safety, performance, and quality compliance of the medical device.
• Authorization Letter: If the application is submitted by an authorized representative on behalf of the manufacturer, an authorization letter from the manufacturer is required.

Office Locations & Contacts

Central Drugs Standard Control Organization


Ministry of Health and Family Welfare


Directorate General of Health Services
FDA Bhavan, ITO, Kotla Road,
New Delhi -110002
Phone: 91-11-23216367(CDSCO)/ 23236975
Email: [email protected]
Contact Details - link
List of zonal Offices – link

Eligibility

Following is the list of who can apply for CDSCO Medical Device Registration in India:

• The Manufacturer has a registered office in India
• The Authorized Agent of the Manufacturer
• The Subsidiary of the Manufacturer
• Any other importer
• Domestic Manufacturer.

Fees

• The applicant has to pay the prescribed fee as per the authority request.

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The entire process can be completed within 30 - 45 days or as per the timeline advised by the respective department authority.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicants must complete the application form before submitting it. Incomplete applications will not be accepted.
• Applicants must provide genuine information while applying for this procedure.

Required Information

• Name and address of the applicant
• Name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device
• Details of medical device
• Generic Name
• Model No.
• Intended Use
• Class of Medical device
• Material of Construction Dimension
• Shelf Life
• Sterile or Non-Sterile
• Brand Name

Need for the Document

• The medical device license in India is known as the "Medical Device Registration Certificate" (MDRC) or "Import License" for medical devices.
• A medical device license is required to import, sell, and distribute medical devices in India. It ensures that the medical devices comply with safety, quality, and performance standards set by the CDSCO.

Information which might help

• User Manual – link

For more information

• link
• link

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Approval Process

• link
• link

Others

A medical device license in India is required for various purposes related to the import, sale, and distribution of medical devices. Here are some of the primary uses of a medical device license:

• Importation
• Sale and Distribution
• Compliance with Regulations
• Consumer Safety
• Market Access
• Post-Market Surveillance
• Trust and Confidence