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Regulation of CT Equipment, All Implantable Devices, MRI etc – New Rule

Regulation of CT Equipment, All Implantable Devices, MRI etc – New Rule

The CDSCO brought about a new amendment on 18th April, 2021 wherein all the following devices will be effective from 1st April, 2021. 

  1. All Implantable Devices
  2. CT Scan Equipment 
  3. MRI Equipment 
  4. Defibrillators 
  5. PET Equipment 
  6. Dialysis Machine 
  7. X-Ray Machine 
  8. Bone Marrow Cell Separator 

All the manufacturers importing the above mentioned, need to get the import license to continue selling in India. In the view of the above, if the manufacturer is already selling in India, has submitted the application, will get a 6 month extension or till the Government takes a decision on the Import License. 

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