In February 2019, the Ministry of Health & Family, Welfare notified that the following medical devices will be regulated as “Drugs” in India starting 1st April 2021.
- (1) All implantable devices
- (2) CT scan equipment
- (3) MRI equipment
- (4) Defibrillators
- (5) PET equipment dialysis machine
- (6) X-ray machine
- (7) Bone marrow cell separator
As per this regulation, the Central Drugs Standard Control Organization (CDSCO) on April 18, 2021, has issued an amendment order regarding the regulation of these devices. All manufacturers importing the above mentioned, must get the relevant import license before they can continue selling or import these into India. In view of the above, if the manufacturer is already selling in India, has submitted the application, they will get a 6-month extension or till the Government takes a decision on the Import License.