In India, the SUGAM online e-Governance portal facilitates the submission, review, and approval of applications pertaining to medical devices. This platform, managed by the Central Drugs Standard Control Organization (CDSCO), aims to establish a robust regulatory framework for medical device registration processes. In addition to SUGAM, stakeholders can also leverage the National Single Window System for further streamlining of regulatory procedures.
Advantages of SUGAM
The SUGAM portal offers several advantages to applicants, including:
- Direct application submission for all licenses to the CDSCO
- Easy tracking of submission status
- Efficient query handling
- Direct document upload for submission activities
Details Required for SUGAM Account Creation
Creating an account in the SUGAM portal requires providing specific details and information, including:
- Username
- Password
- Name
- Mobile number
- Designation
- Copy of ID proof
- Undertaking (Template provided in SUGAM page)
- Organization Name
- Organization Type
- Corporate Identification Number (CIN)
- Address
- Contact number
- Fax number
- Email ID
- Copy of Corporate address proof (Certificate of Incorporation)
Step-by-Step Guide to Creating an Account
- Visit the SUGAM online portal and navigate to the account registration section.
- Fill out the registration form with the required details, including your username, password, personal information, and organization details.
- Upload copies of your ID proof, undertaking, and corporate address proof as specified.
- Review the information provided and ensure its accuracy.
- Submit the registration form and await confirmation of your account creation.
- Upon successful account creation, log in to the SUGAM portal using your username and password.
Leveraging the National Single Window System
In addition to the SUGAM portal, stakeholders can benefit from the National Single Window System, which integrates multiple regulatory processes into a single platform. This system enables seamless exchange of information between stakeholders and regulatory authorities, further enhancing efficiency and transparency in the registration process.
National Single Window System (NSWS):
On January 1, 2024, a notice was published on the National Single Window System (NSWS). The NSWS Portal has been launched by the CDSCO.
NSWS has been established as a ‘genuine single-window system which acts as a one-stop shop for all approvals in future’. To give the business user a consistent and smooth transition experience, Currently, only few medical device applications will be accepted.
Creating an account in the SUGAM online portal for medical devices is a crucial first step for manufacturers, importers, and distributors seeking regulatory approval in India. For assistance with account creation or navigating the registration process, reach out to 8C Healthcare. Our team provides expert guidance and support to streamline your regulatory journey.
If you are an importer, distributor, or manufacturer struggling to create an account in the SUGAM online portal for medical devices, please feel free to reach out to 8C Healthcare for assistance. Contact us at contact@8chealthcare.com.
