Last Updated on April 5, 2024 by The Health Master

Medical Devices

In the realm of regulatory submissions, the Central Drugs Standard Control Organisation (CDSCO) has taken significant steps towards modernization and digitization of Medical Devices.

One of the recent developments includes the shift towards online submission of Period Safety Update Reports (PSUR) related to the marketing authorization of medical devices and in-vitro devices.

This transition marks a pivotal evolution in streamlining the regulatory procedures, aiming for efficiency and ease of access for stakeholders in the healthcare industry.

CDSCO’s Transition to Online Submission

• The CDSCO has announced the discontinuation of offline submission of PSURs for medical devices and in-vitro devices from April 1, 2024.
• Applicants are now required to use the Online System for Medical Devices portal for submitting PSURs, following a designated checklist.
• Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), emphasized the mandatory online submission process and the cessation of offline modes for processing.

Impact of Online Submission on Regulatory Compliance

• The digital submission system ensures a more efficient and standardized approach to regulatory compliance.
• Elimination of manual paperwork reduces potential errors and improves data accuracy.
• Real-time tracking and monitoring of submissions enable quicker response times and enhanced transparency in the review process.

Embracing E-Governance Mechanisms

• CDSCO’s transition towards online submission of PSURs is a part of a broader initiative to implement e-governance mechanisms within the organization.
• The organization has been progressively shifting various application and approval processes to online modes in recent years.
• The move aims to enhance operational efficiency, reduce bureaucratic hurdles, and foster a more agile regulatory framework.

NSWS and DDRS

• The launch of National Single Window System (NSWS) aims to offer a streamlined process for obtaining all necessary approvals in the medical devices industry.
• Invest India, in collaboration with Tata Consultancy Service (TCS), has developed the NSWS portal to provide a unified platform for regulatory activities.
• Additionally, CDSCO’s plan to establish Digital Drugs Regulatory System (DDRS) reflects a commitment to building a unified digital ecosystem for ensuring quality, safety, and compliance across drug, medical device, and cosmetic sectors.

“The proposed DDRS is aimed at building trust and confidence in the quality of drugs, medical devices, cosmetics, etc., in the domestic and global market.” – CDSCO

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