The Central Drugs Standard Control Organization (CDSCO) is the Indian licensing authorizing for approving any new Medical devices, Drugs and Pharmaceuticals which is to be imported to India. The CDSCO has released a new Medical device rule “Medical Device Rules (MDR), 2017” to maintain global standards in manufacture, import and sale. This rule has been effected from January 2018 and the CDSCO has been releasing various updates and guidance regarding the rules MDR-2017.
In recent, the CDSCO has incorporated changes in the existing Medical device regulations. On 3rd December 2018, the CDSCO has officially released a notification stating that the following four medical devices (intended for use in human beings) are categorized as ‘drugs’ with effect from 1st January 2020.
- Nebulizer
- Blood Pressure Monitoring machine
- Digital thermometer
- Glucometer
The CDSCO has also added eight other devices to the list on On 8th February 2019 and mandated the manufacturers to register them as ‘Drug’ before 1ST April 2020.
- X-ray machines,
- CT scan equipment,
- MRI equipment,
- PET equipment,
- Defibrillators,
- Dialysis machines,
- Bone marrow cell separators,
- All implantable medical devices.
Earlier there was no distinct and separate regulation for Medical devices. The government understands the need for separate regulations for devices and drugs and has introduced the Medical Device Rules 2017. It is expected that more medical devices still continue to be defined as drugs under the Drug and Cosmetics Act (DCA).
To know more about new Medical Device Regulations please visit our Blogs.
