Medical device manufacturers need to resubmit MSC and NCC as CDSCO launches Automated Process

New Delhi: Through a recent notice, the Central Drugs Standard Control Organization (CDSCO) has asked all concerned stakeholders, medical device manufacturers, to resubmit fresh Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC) due to an upgrade in the online system, which now features an auto-generation workflow for these certificates.

This came as the Central Drugs Standard Control Organization (CDSCO) has introduced an upgraded online system with a new workflow for auto-generating Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC) for medical devices licensed by the Central Licensing Authority.

This initiative aims to improve ease of doing business and streamline regulatory processes.

A Market Standing Certificate (MSC) from the Central Drugs Standard Control Organization (CDSCO) verifies that a pharmaceutical or medical device manufacturer holds a valid manufacturing license and has been actively selling their products in the Indian market. It's often required by foreign regulatory bodies for registering products in other countries. The MSC also demonstrates compliance with regulatory standards and ensures quality assurance.

A Non-Conviction Certificate (NCC) is a document issued by the Central Drugs Standard Control Organization (CDSCO) to medical device manufacturers and importers in India. It verifies that a company has not been convicted of any offenses related to serious injuries or deaths associated with its medical devices, reported malfunctions of its devices, or instances where its devices do not meet quality standards.

The notice stated,

"In order to promote ease of doing business and to simplify the regulatory procedure, the current online application workflow for grant of a Market Standing Certificate (MSC) and Non-Conviction Certificate (NCC) for medical devices licensed by Central Licensing Authority is upgraded in the Online System for Medical Devices with a new workflow for auto-generated MSC and NCC certificates."

In this regard, the notice further stated that all the current MSC and NCC applications received by CDSCO in the old workflow will be automatically rejected by the system.

In view of the above, the committee requested that all concerned stakeholders resubmit fresh MSC and NCC applications from the date of issuance of this notice.

To view the official notice, click the link below:

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