What is CDSCO SUGAM?

CDSCOs responsibilities are approving new drugs, conducting clinical trials, having quality control on imported drugs and medical devices, etc. CDSCO SUGAM PORTAL enables CDSCO officials to process the application online and generate permission online and make workflow easy and convenient. 

The expert team of Operon Strategist makes your registration process easy and quick so that you can plan your start-up faster. We make sure that your process of CDSCO SUGAM registration becomes hassle-free, we provide a one-stop solution for all medical device regulatory-related queries. 

CDSCO Sugam Portal Registration & Online Login: 

SUGAM is a single window interface to access online services offered by CDSCO. This portal allows users to update and upload data on their website related to the license of drugs & medical device manufacturing facilities in India. The SUGAM PORTAL is a single-window interface. To apply for any form of user, you need to register on the portal first. The comprehensive database of SUGAM PORTAL includes details of the manufacturer, manufacturing site, etc. The applications which are submitted on SUGAM online portal are approved/rejected by CDSCO. For the registration process applicants need to submit necessary documents on an online portal. 

SUGAM online portal allows us to avail ourselves of the following services: 

• Online submission 
• Review 
• Grant of license /permission. 

Steps involved in the CDSCO SUGAM Registration process: 

• Fill in the details given in the registration form and get the login credentials. 
• Open the link https://cdscoonline.gov.in/CDSCO/homepage  and sign up. 
• After signing up provide the purpose of registration 

• Upload necessary documents. 
• After online registration, applicants need to submit hard copies to CDSCO for the further verification process. 

Who can apply for CDSCO SUGAM Portal? 

• Manufacturer or importer of medical devices or IVDs who wants to obtain CDSCO Manufacturing license /CDSCO Import license /CDSCO registration. 
• Indian Agents 
• Foreign enterprises holding Indian subsidiary 

Benefits of CDSCO SUGAM Login: 

• It provides a centralized dashboard to monitor regulatory clearance in India. 
• It provides a high level of transparency.

• It reduces delays in regulatory processes. 
• It provides a single-window user interface. 

A few key points to consider are, 

• Applicants need to register with verified credentials 
• Fill out the complete user profile, it is mandatory. 

• If an applicant has more than one manufacturing unit in his organization, then the applicant must register its corporate organization on to SUGAM portal and then registers its sub-units on the portal. 
• At any step, if you get stuck, we will advise you to take a medical device regulatory consultant’s help. 

CDSCO SUGAM online portal is launched for the ease of the manufacturer /importer of medical devices. Manufacturers or importers or those who want to avail of the services should fill out the form and start the process but they get stuck with errors if any occurred in between and if the data is required not filled properly queries can be raised by the CDSCO, which may result in denial/rejection of the application. Though it is simple and user-friendly one should take guidance from a medical device regulatory consultant for the error-free and timely process. Medical device regulatory consultants can guide you in the whole registration process, and documentation and meet the deadline. For queries related to this, you can contact us too! 

Reference link: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/SUGAM_user_manual.pdf