The CDSCO has issued a circular on submission of online applications of Periodic Safety Update Reports (PSURs). This is in respect of Marketing Authorization (MA) of Medical Devices/ In-vitro Devices. The circular aims to streamline the regulatory submission procedure for PSURs. This circular is dated March 19, 2024.
The circular states that all applicants must now submit their PSURs through the Online System for Medical Devices portal. Additionally, applicants shall also follow the checklist provided on the portal while submitting PSURs. Consequently, from April 1, 2024, the facility for offline submission of applications will no longer be available for processing. Therefore, authorities will not permit applicants to submit their applications in hard copy or any other mode.
In conclusion, this move aims to enhance efficiency and transparency in the regulatory process, making it easier for stakeholders to submit PSURs related to Medical Devices/In-vitro Devices. By transitioning to online submissions, authorities can streamline the review process and ensure timely evaluation of safety updates for these critical healthcare products.
