SUGAM Registration- MD/ IVD in India
We at CliniExperts, make sure that our expert team creates your registration easy and quick so that you can focus on more important aspects of your product launch. Our team ensures that your registration is hassle-free, we also act as an authorized agent if you are an importer, providing a one-stop point of contact for all your business in India.
SUGAM Registration- MD/ IVD – Overview
The registration process for medical devices is primarily done on the SUGAM portal, a website where the applicants apply for approval of licenses, FSC and Registration numbers. In addition, the portal provides an interface and ease of access for applicants to track the submitted application, query responses and the ability to download permissions issued by the CDSCO.
Any applications submitted are reviewed and approved/rejected by the CDSCO. The process involves the submission of necessary documents on the online portal. After uploading the documents, applicants must submit a hard copy of the papers to the CDSCO (Medical Device Division) for further approval on the medical device portal.
Who Can Apply?
A manufacturer/importer of Medical Devices or In-Vitro diagnostics devices who intends to get a manufacturing license/registration/importing license can do the registration on the SUGAM portal.
How To Apply?
The Applicant must follow the following process:
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Step 1: An applicant (manufacturer/importer) requires a user login id with the credential to apply on the SUGAM portal (https://cdscomdonline.gov.in/NewMedDev/Homepage).
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Step 2: The registration requires uploading all the self-attested copies of the undertaking (the documents which include the name and address of the Company and issued by the Government Authority).
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Step 3: The applicant also has to upload Aadhar ID proof (Authorised person/agent), the manufacturing license or Wholesale Drug License and the certificate of incorporation.
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Step 4: After online registration, the applicant must submit hard copies of all the uploaded documents and the Cover Letter to the CDSCO for verification. The CDSCO will approve the Sugam Registration after evaluating the proposed application and the documents.
Validity
The validity of the license is not defined.
Fee Involved
No fees are required for registration on the online portal.Important Documents
A set of required documents include:
- Annexure Sheet
- Cover Letter
- Undertaking
- Aadhaar/Pan Card
- COI/IEC/GST Certificate
- Wholesale License/Manufacturing License
Timeline to get from Central Drugs Standard Control Organisation
5 to 7
WORKING DAYSEssential Tips
- A wholesale license or a manufacturing license is a must for SUGAM registration for all Medical Device Registration
- TCOI/IEC/GST certification is necessary for completion of the registration process.
- The SUGAM undertaking should be signed, and the address given on the undertaking must corroborate[SG2] with the supportive submitted documents, e.g., COI/GST/IEC.
Expert Advise
Applicants must obtain the Wholesale License in FORM 21B, 20B to register on the SUGAM Portal for import purposes.
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Frequently Asked Questions
Can we apply for MD and IVD on the SUGAM Portal?
Yes, the application for both MD and IVD can be made on the SUGAM Portal.
As an importer, do we require a manufacturing and wholesale license for registration on the SUGAM Portal?
The wholesale license is required for registration on the SUGAM portal by the manufacturer or importer
Who needs to submit the Certificate of Incorporation?
The manufacturer and the importer both need to submit the Certificate of Incorporation on the SUGAM Portal.
Does SUGAM Portal require details of Authorized Agent information in the registration process of manufacturing medical devices in India?
The Authorized Agent information is only required for importing the Medical Devices. No information is required for any registration process. The authorized agent acts as the point of contact for all regulatory paperwork and licensing for the importer.
How does the manufacturer/importer get the correspondence from the CDSCO?
All the correspondence from the CDSCO will be sent to the registered email-id on the medical devices online portal.