PSUR – Periodic Safety Update Reports 

The Central Drugs Standard Control Organization (CDSCO) issued a new circular, File No.: PSUR-13011(15)/1/2024-eoffice, on March 9, 2024, which specifies that submissions of PSUR’s (Periodic Safety Update Reports) must now be made through the dedicated portal at https://www.cdscomdonline.gov.in/. The announcement also  states that from April 1, 2024, the option to submit PSUR applications offline, whether by hard copy or any other alternative method, will no longer be available. This move is part of CDSCO’s efforts to streamline medical device and pharmaceutical registration processes in India.

The Broader Context of CDSCO’s Digitalization

The CDSCO  has been progressively moving its application and approval processes to an online format to  align with the adoption of e-governance within the organization. This digital transformation is essential for regulatory compliance in the rapidly evolving medical device sector in India. Recently, they had made 2 changes prior to the PSUR Update as below

1. In November 2023, the CDSCO mandated that all applications for Post Approval Changes (PACs) concerning marketing authorization for human vaccines and antisera be submitted via the Sugam Portal’s online system. This directive was part of phasing out offline submissions, effective from December 1, 2023. This directive, which aligns with the regulatory framework for medical devices and utilizes tools like MD-14 forms, was part of phasing out offline submissions, effective from December 1, 2023.
2. On January 1, 2024, the CDSCO introduced the National Single Window System (NSWS) portal, initially incorporating three activities tailored for the medical devices sector, aiming to enhance the ease of doing business within the industry and ensure efficient registration processes for medical devices in India.

Conclusion

The mandatory online submission of PSUR’s (Periodic Safety Update Reports) represents a significant advancement in the regulatory framework governing medical devices and in-vitro diagnostic devices in India. It aligns with global trends towards digitalization and e-governance, offering manufacturers and importers a more efficient, transparent, and accessible process for regulatory compliance.  Morulaa supports manufacturers in keeping up with the changing regulatory landscape in India and its digital transformation. This ensures compliance and facilitates timely market access for your products in India. For more information on how Morulaa can assist with SUGAM registration, MD-14 applications, or any other regulatory requirements, contact us on [email protected] or Click Here to know more.