Medical Devices Rules amended to provide for setting up of State Medical Devices Testing Laboratories

The Department of Health and Family Welfare, vide the Medical Devices (Amendment) Rules, 2023, has introduced the provision for State Medical Devices Testing Laboratories which are medical device laboratories established or designated by State Governments.

Now, State Governments can establish State Medical Devices Testing Laboratories for testing and evaluation of medical devices or to carry out any other specified functions. All medical device testing laboratories must be duly accredited by the National Accreditation Body for Testing and Calibration Laboratories.

Please click on the link for a detailed read of the notification.

Source: Department of Health and Family Welfare