The Central Drugs Standard Control Organization (CDSCO) has increased the number of medical device categories now being regulated by the Medical Device Rule 2017. The following categories of medical devices are now being regulated under the Medical Device Rule 2017, based on their intended use, risk associated with the device and other parameters.
- (1) Nephrology and renal care (44 devices included)
- (2 )Operation theatre (26 devices)
- (3) Pain management (26 devices)
- (4) Personal protective equipment (PPE) (32 devices)
- (5) Software (60 devices)
- (6) General hospital (57 devices)
The CDSCO began issuing new risk-based medical device and in vitro diagnostic (IVD) classification lists in late 2020 in order to clarify regulatory pathways and compliance requirements for manufacturers and sponsors under the Regulations.
Reference:
- Classification of Medical devices pertaining to Nephrology and Renal Care (File No. 29/Misc./03/2020-DC (143))
- Classification of Medical Devices Pertaining to Operation Theatre (File No. 29/Misc./03/2020-DC (199))
- Classification of Medical Devices Pertaining to Pain Management (File No. 29/Misc/03/2020-DC(178))
- Classification of Medical Devices Pertaining to Personal Protective Equipment (File No. 29/Misc./03/2020-DC (186))
- Classification of Medical Devices Pertaining to Software (File No. 29/Misc./03/2020-DC (198))
- Classification of Medical Devices Pertaining to General Hospital (File No. 29/Misc./03/2020-DC (193))