CDSCO Medical Device Registration Disposal Rejection Of Long Pending Applications on SUGAM Portal Awaiting Query Response
CDSCO Medical Device Registration: SUGAM Query Rejection
INDIA, 04 May 2026 In view of new regulations for pending applications under SUGAM portal for CDSCO medical device registration, it is pertinent to note that CDSCO under the ministry of health and family welfare is currently purging old cases due to non response from the applicants. The above order pertains to a previous office order issued on 16 January 2026, under the file number IT-11011(11)/1/2026 Under SUGAM Portal Registration, where more divisions have been added such as GCT BABE Ethics Committee and Veterinary (pending since 2016). Through this new mechanism, the Central Drugs Standard Control Organisation (CDSCO) has initiated a reminder process for applicants who have applied through the SUGAM portal. Applicants seeking services of medical device regulatory consulting, medical device consultancy and CDSCO registration consultants shall keep in mind to check all the queries.
CDSCO Medical Device Registration Step by Step Query Resolution and Application Disposal Process
As against an indefinite waiting period for resolving the queries, the new procedure takes the help of a tightly structured and automated reminder matrix and then terminal enforcement. This holds true for the queries raised regarding SUGAM Portal Registration files too.
Step 1: The Initial Review and Generation of the Customised First Reminder For SUGAM Portal Registration
The process is started because an application remains pending at the SUGAM portal owing to outstanding questions posed by the evaluation officers. CDSCO starts its formal process of sending reminders by preparing a personalized reminder which is sent to the individual account and email id of the applicant. For consultancy services for medical devices, this notification clearly explains all the technical shortcomings and missing data needed to be provided by the applicant.
Step 2: Continuous Escalation via the Second and Third Reminders CDSCO Medical Device Registration
In the case where the applicant doesn’t respond appropriately to the first reminder, the system sets up an automatic tracking timeline using a 30 day cycle. In 30 days from that first reminder, the CDSCO will issue the second reminder. In 30 days again after the second reminder, the third reminder will be issued. The applicants who are dealing with the medical device regulatory consulting service must take the reminders seriously.
Step 3: Issuance of the Fourth and Final Disposal Notice with CDSCO Registration Consultants
In cases where an applicant leaves the application unanswered even after three warnings have been issued, then the system enters the enforcement stage. The fourth and last letter is generated and dispatched by CDSCO exactly thirty days after the third reminder is sent out. This letter serves as the key notice to the applicant informing him/her that the application has entered the ultimate stage of reminders as a result of not responding through both email and the web portal.
Step 4: Final Execution of Application Rejection and Financial Forfeiture for Medical Device Regulatory Consulting Services
The final step in this regard would be the automatic termination of the case through administration. The moment that the fourth letter is sent and the associated deadlines pass, the application status of the product is automatically rejected by the CDSCO. This is in addition to the total loss of the entire application fee which had been initially submitted to the government by the manufacturer.
Step 5: Special Accelerated Cleanup for Legacy Files
In addition to the above immediate enforcement rule, there is a different rule that is applicable to legacy applications which have been pending for more than two years. In case of these particular historical applications that have already undergone the process of getting three reminders before this new notice came into being, CDSCO gives the last deadline of 30 days starting from the actual date of this notice, which is 04 May 2026. Should these legacy applications fail to respond to the queries within the span of 30 days, there will be an immediate rejection notice without any further administrative procedure. Those companies dealing with CDSCO registration consultants should prioritize these legacy applications.
Final Steps for Medical Device Consultancy Support
Access the SUGAM portal directly to check all open applications for any unanswered questions. You will have to collaborate very well with your Indian Authorised Representative or license holder to make sure that they are keeping track of all the government notifications related to any questions. Priority should be accorded to all applications that have been in the system for two years and above since they are likely to be deleted imminently. Make sure that your answers to all the unanswered questions are submitted through email and the portal before the next interval of reminding period or grace period of 30 days elapses. In case you are not sure of your current application status or need professional help in compiling and coordinating your technical answer, then the Indian regulatory team of Morulaa Healthtech is ready to help you in assessing your application status and executing the right action.
Other posts
Don't let red tape slow down your vision. We simplify complex Indian building regulations so you can focus on creation. Our team provides the clarity you need during the project and the support you deserve after it’s done. Smooth approvals, smarter builds.