The Central Drugs Standard Control Organization (CDSCO) on April 03, 2024, notified regarding the Strengthening of private Medical Devices Testing Laboratories in the country.
The following has been stated:
• It has stated that certain private testing labs have been registered under MDR, 2017 for testing & examination of certain medical devices in the country on behalf of the manufacturer. In order to strengthen the private testing facility for medical devices in the country, this office is in the process of identifying the existing private labs having the facility to test the medical devices, so that these labs may be registered under MDR, 2017.
• It has been observed that your organization has having testing facility for carrying out various tests of medical devices. The medical devices require various tests including Physical, chemical, microbiology, mechanical & electrical etc.
• it has requested that you may kindly identify your facility for testing of the above tests for medical devices and submit the application in Form MD-39 along with the requisite information with fees as per MDR, 2017 for registration of testing laboratory on behalf of the manufacturer.
[Notification No MED/2/2024-eoffice]
