In a significant regulatory overhaul aimed at streamlining administrative workflows and enhancing transparency, the Central Drugs Standard Control Organization (CDSCO) has announced the implementation of an automated re-application process for the issuance of Compliance Certificates (CoCs) for medical device manufacturers. This initiative is set to take effect immediately and mandates that all existing manufacturers re-apply through the updated digital mechanism.

The move aligns with the Government of India’s broader vision of promoting ‘Ease of Doing Business’ and fortifying the regulatory ecosystem under the Medical Devices Rules (MDR), 2017. It comes as part of CDSCO’s ongoing digital transformation agenda designed to ensure speed, traceability, and efficiency in regulatory submissions and approvals.

What This Means for Manufacturers
Under the new directive, manufacturers who have previously obtained CoCs are required to re-apply through the Sugam Portal, the CDSCO’s centralized online platform. The revised process will employ automated validation protocols, ensuring quicker turnaround times, minimal human intervention, and robust data integrity. All re-applications must conform to the prescribed Technical and Regulatory Requirements under the MDR, 2017.

This automated mechanism will also facilitate auto-generation of CoCs post verification, eliminating bureaucratic delays that have historically plagued the approval process.

Key Features of the Automated Process:
Digital Document Upload: All submissions, including technical dossiers, undertakings, and manufacturing licenses, must be uploaded electronically.

Integrated Review System: Real-time validation against pre-defined regulatory checklists.

Auto-Issuance Capability: Certificates will be issued digitally upon successful system verification.

Audit Trail: Complete traceability of application status and historical actions.

Industry Response
Industry stakeholders have welcomed the announcement, hailing it as a step forward in aligning India’s regulatory framework with global best practices. The initiative is anticipated to enhance compliance oversight, reduce redundancy, and improve the overall ease of engaging with regulators for both domestic and international manufacturers.

A senior CDSCO official stated, “This new system will not only foster greater regulatory compliance but also significantly reduce processing timelines, providing a more business-friendly environment for the MedTech industry.”

Transition Guidelines and Support
CDSCO has issued comprehensive guidance documents to facilitate a smooth transition. Manufacturers are advised to refer to the updated Frequently Asked Questions (FAQs) and Standard Operating Procedures (SOPs) available on the CDSCO portal. Additionally, dedicated helpdesk support has been established to assist stakeholders during the migration phase.

Call to Action
All medical device manufacturers and importers are strongly advised to:

Log in to the Sugam Portal and initiate the re-application process without delay.

Ensure their existing documentation is in compliance with the latest MDR provisions.

Consult regulatory experts or CDSCO representatives for any clarifications.

Failure to comply within the stipulated timelines may lead to regulatory action, including suspension or cancellation of previously granted certificates.