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CDSCO Rolls Out Automated Certification System, Mandates Fresh Applications from Medical Device Companies
The Medical Device Division of CDSCO issued a public notice on April 9, stating that the existing application workflow has been replaced with a new automated process. “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,” the notice reads.
- By Newsdesk
- New Delhi
- Apr 11, 2025
In a significant move to streamline regulatory compliance for medical device companies, the Central Drugs Standard Control Organisation (CDSCO) has announced the implementation of an automated system for issuing Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC). The upgrade, aimed at enhancing efficiency and transparency, requires all stakeholders to re-submit their applications through the revamped online portal.
The Medical Device Division of CDSCO issued a public notice on April 9, stating that the existing application workflow has been replaced with a new automated process. “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,” the notice reads.
As part of the transition, all pending applications submitted under the old system will be automatically rejected. Stakeholders must now re-apply using the updated process. “All current MSC and NCC applications received by CDSCO in the old workflow will be automatically rejected by the system,” the notice clarified, urging applicants to submit fresh requests under the new system effective immediately.
The Non-Conviction Certificate serves as an official declaration that a company has not been convicted of any violations related to the safety or quality of its medical devices—an essential requirement for maintaining regulatory credibility. The Market Standing Certificate, meanwhile, is used to demonstrate a firm’s compliance with regulatory standards and is often needed for export approvals or tender participation.
As outlined in earlier guidance documents, these certificates are available only to Indian medical device manufacturers and importers holding valid licenses. The move toward automation is expected to significantly reduce processing time and eliminate bureaucratic delays in certification.
This upgrade underscores the CDSCO’s ongoing efforts to modernize India's medical device regulatory landscape, aligning it with global best practices.