SUGAM Registration for MD/IVD in India: A Step-by-Step Guide

The Central Drugs Standard Control Organization (CDSCO) regulates IVD product registration in India. The amount of IVD devices that require full technical documentation to back their registration submissions has grown exponentially under the amended Medical Device Rules, 2017.

Previously, only necessary IVD devices had to be registered with the entire device master file prior to being sold in India. Manufacturers, importers, and distributors of such products are required to register on the SUGAM Portal, an online platform to enable regulatory approvals.?

In this step-by-step guide, we walk you through the SUGAM registration procedure for medical devices (MD) and in vitro diagnostics (IVD) in India.?

What Is CDSCO??

Being India's National Regulatory Authority (NRA), the Central Drugs Standard Control Organization (CDSCO) is responsible to the Directorate General of Health Services of the Ministry of Health & Family Welfare.

Besides new drug approvals, medical devices, and cosmetics, CDSCO is also responsible for carrying out clinical trials, establishing standards, monitoring the quality of imported drugs, medical devices, and cosmetics in the country, and coordinating state drug control agencies' efforts.?

India's Central Drugs Standard Control Organization (CDSCO) initiated SUGAM, an online application portal, in January 2016 for several services. The SUGAM offers services of online submission, review, and NOC/permission issuing.?

Overview of SUGAM Registration for IVDs?

The SUGAM portal, a website where applicants request for acceptance of licenses, FSC, and registration numbers, is where the medical device registration procedure is mainly completed.

Moreover, applicants can trace their submitted applications, find answers to their queries, and receive licenses issued by the CDSCO through the easy of use of the portal.? The CDSCO scrutinizes all applications and determines whether to approve or reject them.

The procedure entails submitting the required paperwork using the web site. Applicants must upload their documents to the medical device portal and then provide a hard copy of them to the CDSCO (Medical Device Division) for additional clearance.?

Who May Apply for IVD Registration??

If a medical device or in-vitro diagnostics device manufacturer or importer wants to get a manufacturing, registration, or import license, they can do so using the SUGAM site.?

What Is IVD??

A medical device used to analyze human or animal materials is known as an in-vitro diagnostic (IVD), according to the Central Drugs Standard Control Organization (CDSCO). IVDs can be used to monitor, diagnose, or assess a person's physiological condition.? ? ?

Step-by-Step Guide for SUGAM Registration for IVD or MD?

Step 1: Create an Account on the SUGAM Portal?

• Visit the official SUGAM Portal (https://cdscoonline.gov.in).?

• Click on "Sign Up Here" and select the appropriate user type (Importer, Manufacturer, Indian Agent, etc.).?

• Fill in the required details such as organization name, email ID, mobile number, and address.?

• Upload mandatory documents like:?

• PAN card of the company?

• GST registration certificate?

• Authorized signatory’s ID proof?

• Submit the registration request and wait for CDSCO approval.?

Step 2: Login and Profile Completion?

1. After receiving approval, log in to the SUGAM portal.?

1. Complete the company profile by providing:?

• Details of the responsible person?

• Manufacturing/import facility details?

• Product category details?

1. Ensure all mandatory fields are correctly filled before proceeding.?

Step 3: Apply for MD/IVD Registration Certificate?

• Navigate to the Medical Devices section.?

• Select the appropriate registration form (e.g., MD-14 for import license, MD-5 for manufacturing license).?

• Upload required documents, which may include:?

• Free Sale Certificate (for imports)?

• ISO 13485 certification?

• Product dossier?

• Undertaking or declaration forms?

• Pay the applicable government fees online.?

• Submit the application and track the status through the dashboard.?

Step 4: CDSCO Review and Query Response?

• CDSCO will review the application and may raise queries.?

• Respond to any queries within the stipulated timeline by uploading the necessary clarifications or documents.?

• Once satisfied, CDSCO will approve the registration and issue the license.?

Step 5: Download and Use the Registration Certificate?

• Once approved, log in to the SUGAM portal.?

• Navigate to the Approved Applications section.?

• Download the certificate and ensure compliance with regulatory requirements before commercialization.

?Common Challenges and Solutions at SUGAM:?

1.????? Incomplete Documentation?

·??????? Make sure all documents are prepared according to CDSCO guidelines prior to submission.?

·??????? Make use of the document checklist uploaded on the portal to ensure there is no missing paperwork.?

2. Delayed Approvals?

·??????? Check the status of the application from time to time on the SUGAM dashboard.?

·??????? Respond to the questions raised by CDSCO within the specified period to avoid further delays.?

3. Technical Issues with the Portal?

·??????? In case of login issues, attempt clearing cache and cookies or changing browsers.?

·??????? In the event of system failures, get in touch with the CDSCO helpdesk or technical support.?

4. Regulatory Requirement Confusion?

·??????? Get yourself updated with the latest guidelines on the official CDSCO website.?

·??????? Consult professionals if necessary to confirm regulatory compliance.?

5. Delays in Payment Processing?

·??????? Process payments using authorized modes as mentioned on the portal.?

·??????? Save payment transaction information for reference purposes in case of a dispute.?

6. Query Response Difficulty?

·??????? Make sure answers to CDSCO questions are clear, concise, and backed up by proper documentation.?

·??????? Task a regulatory specialist to deal with communications with CDSCO to enhance precision and efficiency.?

Conclusion?

SUGAM registration is crucial in guaranteeing that medical devices and in vitro diagnostic (IVD) products are complying with CDSCO regulatory requirements. Through a systematic process and having all the documents in order, manufacturers and importers can easily go through the registration process.

Keeping track of regulatory requirements and responding to CDSCO queries in a timely manner can contribute meaningfully towards eliminating delays and expediting approvals.