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USA: FDA Modifies List of Recognized Standards – June, 2021

USA: FDA Modifies List of Recognized Standards – June, 2021

  • 2021-06-25 12:45:15

According to FDA Modernization Act, FDA publishes a series of recognized consensus standards modifications. FDA believes these modifications are closer to modern requirements for medical devices to ensure public benefit improvement. The medical device manufacturers should notice the standards change to avoid the FDA challenge.

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INDIA: Central Drugs Standard Control Organization (CDSCO) arranges a Proposal for Designation of Central Testing Laboratories for Medical Devices and In-Vitro Medical Device – April 2018

INDIA: Central Drugs Standard Control Organization (CDSCO) arranges a Proposal for Designation of Central Testing Laboratories for Medical Devices and In-Vitro Medical Device – April 2018

  • 2020-02-14 07:40:37

In light of the new Medical Device Rules 2017, CDSCO/CLA/SLA shall have updated information of laboratories involved in testing of medical device & in vitro diagnostics with respect to their laboratory reports and decision on performance evaluation of products made by stakeholder/regulator.

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