CDSCO Mandates Re-Application for MSC & NCC Certificates After System Upgrade
This directive follows an upgrade to the existing online system, which is now equipped with an automated certification workflow.
The Central Drugs Standard Control Organisation (CDSCO) has announced that all medical device manufacturers and importers in India must re-submit the Market Standing Certificate (MSC) and Non-Conviction Certificate (NCC) applications.
This directive follows an upgrade to the existing online system, which is now equipped with an automated certification workflow.
The Medical Device Division of CDSCO stated in a public notice, "To simplify the regulatory procedure, the current online application workflow for grant of Market Standing Certificate (MSC) and Non-Conviction Certificate (NCC) for medical devices is upgraded with a new workflow for auto-generated certification."
Effective April 9, 2025, the new system invalid all pending applications under the previous workflow.
The notice clearly states, "All the current MSC and NCC applications received by CDSCO in the old workflow will be automatically rejected by the system, and all concerned stakeholders shall re-submit fresh MSC and NCC applications from the date of issuance of this notice, i.e., April 9, 2025."
Certificates Essential for Compliance and Export
The Non-Conviction Certificate (NCC) officially declares that the applying company has not been convicted in any legal case involving product safety or quality violations. According to CDSCO, the NCC is essential to demonstrating legal and regulatory compliance within the medical device sector.
In parallel, the Market Standing Certificate (MSC) is often required for export documentation and government tenders. It verifies that a company complies with required regulatory norms and has a consistent market presence.
The CDSCO’s guidance document highlights that both certificates apply only to entities holding valid manufacturing or import licenses within India. The move to a new automated process is positioned as a step toward digitizing and standardizing compliance mechanisms, although stakeholders are now required to adapt by resubmitting their documentation.
