India, 04 May 2026 - For CDSCO medical device registration, understanding the new rules for pending applications on the SUGAM portal requires knowing that CDSCO under the ministry of health and family welfare is clearing out old files because applicants are not replying to queries this order is connected to an older office order from January 16 2026 under file IT-11011(11)/1/2026 Under SUGAM Portal Registration,  now more divisions are included like GCT BABE ethics committee and Veterinary (applications pending since 2016), the Central Drugs Standard Control Organisation (CDSCO) has initiated a structured reminder mechanism for applicants who have submitted applications on the SUGAM portal. Applicants using medical device regulatory consulting services, medical device consultancy support, or CDSCO registration consultants should check each query early.  As part of this mechanism, CDSCO issues reminders at fixed intervals to inform applicants to respond to the pending queries raised during the evaluation of their applications.

CDSCO Medical Device Registration Step-by-Step Query Resolution and Application Disposal Process

The newly outlined process moves away from indefinite waiting periods and instead relies on a highly structured, automated reminder matrix followed by terminal enforcement. This also affects SUGAM Portal Registration files where query responses remain pending.

Step 1: The Initial Review and Generation of the customised First Reminder For SUGAM Portal Registration

The process begins when an application sits unaddressed on the SUGAM portal due to outstanding queries raised by evaluating officers. The CDSCO initiates its structured reminder mechanism by generating a customized first reminder that is delivered directly to the applicant's account and registered email address. For medical device consultancy teams, this notice specifically details the exact technical deficiencies or missing information that the applicant must address to advance their file.

Step 2: Continuous Escalation via the Second and Third Reminders CDSCO Medical Device Registration 

If the applicant fails to submit a comprehensive response following the initial alert, the system executes an automated tracking timeline based on a strict 30-day cycle. Exactly 30 days after the first reminder, the CDSCO issues a second one. If the applicant does not reply within another 30 days, the system sends a third and final warning. Applicants working with medical device regulatory consulting services should treat each reminder as time-sensitive.

Step 3: Issuance of the Fourth and Final Disposal Notice with CDSCO Registration Consultants

When an applicant allows the application to remain unaddressed past the third warning, the system transitions into an enforcement phase. Exactly 30 days after the issuance of the third reminder, the CDSCO generates and sends a fourth and final communication. This critical document formally notifies the applicant that their application has reached the terminal threshold of the reminder mechanism due to a lack of response through both email and the web portal. At this stage, CDSCO registration consultants can help applicants check whether any response is still pending.

Step 4: Final Execution of Application Rejection and Financial Forfeiture for Medical Device Regulatory Consulting Services

The ultimate step in this process is the immediate administrative termination of the file. Once the fourth notice is issued and its accompanying deadlines lapse, the CDSCO officially changes the application status to rejected. Along with this permanent rejection, the entire application fee amount previously paid by the manufacturer to the government is completely forfeited. For ongoing CDSCO medical device registration matters, timely query response is important.

Step 5: Special Accelerated Cleanup for Legacy Files

A separate, immediate enforcement rule applies to legacy applications that have already been stuck in the pipeline for more than two years. For these specific historical files that have already completed the three-reminder sequence prior to the publication of this new notice, the CDSCO provides a final, non-negotiable window of 30 days counted from the exact date of this public notice, which was issued on 04 May 2026. If these long-pending queries are not answered within this 30-day grace period, a final rejection communication is executed immediately without further administrative delays. Companies working with CDSCO registration consultants should give these legacy files first priority. This also applies to old SUGAM Portal Registration files that have not received a proper query response.

Final Steps for Medical Device Consultancy Support

Log into the SUGAM portal directly to audit all open applications for any unresolved queries. You must also coordinate closely with your Indian Authorized Representative or license holder to verify that they are actively monitoring all official query notifications. Immediate priority must be given to any application that has remained in the system for two or more years, as these are at imminent risk of deletion. Ensure that comprehensive responses to all outstanding queries are submitted through both email and the portal before the next reminder interval or the final 30-day grace period lapses. If you are uncertain about your current application status or require professional assistance in compiling and coordinating your technical response, Morulaa Healthtech’s India regulatory team is available to help you assess your application standing and execute the necessary next steps. This support can also help you assess your CDSCO medical device registration status through medical device regulatory consulting services and medical device consultancy support.