This document outlines the process for obtaining registration and a license for medical devices and diagnostics in India. It describes the key regulatory body, the application process through the Sugam online portal, required documents which include product details, regulatory status and certificates, and fees. It then explains the review process, including potential resubmission if queries are raised, and specifies that the licensing authority aims to grant the license within 9 months of the application submission.

1. MEDICAL DEVICES &
DIAGNOSTICS
ONLINESOLUTION FOR
APPLICATION, SUBMISSION, PROCESSING & GRANT OF
PERMISSION
By:CS Harsha Batra

2. INTRODUCTION
• In India, the manufacturing, import, sale, and distribution of medical devices
are regulated under India’s Drugs & CosmeticAct and Rules (DCA).
• The Central Drug Standards Control Organization (CDSCO) isIndia’s
main regulatory body for pharmaceuticals and medical devices.
• Any person who intends to manufacture a Class A or Class B medical device
including in vitro diagnostic medical deviceshall make an application for
grant of license to the State Licensing Authority.

3. PROCESS FOR MEDICAL DEVICE &
DIAGNOSTIC REGISTRATION
1. Create Login Id by filling the Registration form on Sugam Portal.
2. Username will be corporate email id and it should be unique, which can be used
as user name for future communication.
3. Password length should be at least six characters with at least one number,one
lowercase, one uppercase letter and one special character.
4. Upload necessary documents.
5. After clicking on "Submit" button, a confirmation link will be sent to user’s
registered email id to verify registration.
6. Verify account by clicking on the link sent to the registered email id.
7. After clicking the verification link, registration application of the user will be sent
for approval to the concerned authority.
8. In case of approval/rejection of the application, a mail will be sent to user's

4. registered email id.
9. After receiving approval mail from CDSCO for their user registration, User can
login into the system with User Name and Password as entered in user
registration

5. APPLICATION
After completion of login procedure, application shall be file in Form 40 for Fresh
Registration.
DOCUMENTS REQUIRED
1. Covering Letter-Purpose should be clearly mentioned with page numberand
Index.
2. Self-attested copy of authorization letter to the person issued by the
Director/Company Secretary/Partner of the Indian Agent firm.
3. Detail Product description along with material of construction, intendeduse,
Product specification, product literature, package inserts alongwith a sample.
4. Regulatory status of the said product in country of origin.
5. Regulatory certificates in respect of said product.

6. FEES: 1000 USD for each product.
The licensing authority shall within 9 months from the date of receipt ofapplication
issue such Registration Certificate, which may extend further for not more than
3months.

7. SUBMISSION
FINAL PREVIEW
Once payment is done user can view the complete legal form with payment details
and download the system generated form for signature.
SUBMISSION OF FORM
1. Take print of downloaded system generated form.
2. Sign & Scan form.
3. Upload the document after which the form will be submitted.
After submission of form a file number will generate which will be used fortracking
of application.

8. REVIEW
APPLICATION RECEIVED BY NODAL OFFICER
After successful submission of application, the application will be received by Nodal
Officer, who shall forward the same to Reviewing Officer.
APPLICATION REVIEW
After receiving the application from Nodal Officer, Reviewing officer will check the
application & if it is completed in all respect, he shall forward the application to
Deputy Decision Authority with his comments upon it.

9. RESUBMISSION
1. The Deputy Decision Authority will raise query, if any & sent intimation
to applicant.
2. If Documents are in Order, then forward the application toLicensing
Authority.

10. GRANT OF LICENSE
After receiving the application from The Deputy Decision Authority , the
Licensing Authority will Grant License.
Within 9 months from the submission of application License will be granted.
*The licensing authority shall within 9 months from the date of receipt of
Application issue such Registration Certificate, which may extend further for not
more than 3 months.
* License will remaining valid for the period of 3 years.
*Applications for Renewal of License should be submitted minimum 9 months
Before the expiry of the registration certificate.