CDSCO Circular - Online Submission of PSURs
The CDSCO has issued a circular mandating the online submission of Periodic Safety Update Reports (PSURs) for Marketing Authorization (MA) of Medical Devices and In-vitro Devices. This measure, effective from March 19, 2024, aims to simplify the regulatory submission process for PSURs.
According to the circular, all applicants are now required to submit their PSURs through the Online System for Medical Devices portal and adhere to the provided checklist during submission. From April 1, 2024, offline submission facilities will be discontinued, and applicants will no longer be able to submit applications in hard copy or any other mode.
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This transition to online submissions aims to improve efficiency and transparency in the regulatory process, facilitating stakeholders in submitting PSURs related to Medical Devices/In-vitro Devices. It will enable authorities to streamline the review process and ensure prompt evaluation of safety updates for these critical healthcare products.
