Strengthening Private Medical Device Testing Facilities in India
CDSCO has issued a public notice issued inviting applications from existing private labs to register for testing specific medical devices. These tests include physical, chemical, microbiological, mechanical, and electrical examinations. Interested private labs can submit applications in Form MD-39, along with the requisite fees.
DCGI Meeting with Stakeholders on March 28th Stands Cancelled
This cancellation is due to unforeseen work commitments for the DCGI. The CDSCO encourages stakeholders to contact the CDSCO’s Public Relations Cell (PRO Cell) to reschedule their meetings for a more suitable date. This applies particularly to those stakeholders located outside of Delhi.
Latest Drug Alert Lists for February and January
The CDSCO has stated that in the month of February 2024 it received 676 samples and tested 1,167 samples. Among these samples, it observed that 58 samples did not possess standard quality and identified 2 samples as spurious. Furthermore, in a revised report for January 2024, one specific case stood out. In particular, Sun Pharma Laboratories Ltd. manufactured a batch of Levetiracetam Tablets IP (Levipil 500). Upon investigation, authorities discovered that the actual manufacturer, as per the label claim, denied manufacturing the implicated batch.
Online Submission of PSURs for Medical Devices Made Mandatory
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.
