Ever since the Medical Device Rule 2017 came into effect in January 2018, the Central Drugs Standard Control Organization (CDSCO) has been classifying more medical devices under the definition. In line with that, the following categories of medical devices are now being regulated under the Medical Device Rule 2017, based on their intended use, the risk associated with the device, and other parameters.
(1) Interventional Radiology
(3) Dermatological & Plastic Surgery
(4) Physical Support
(6) In-Vitro Diagnostic Medical Devices (IVD Analyzers, IVD Instruments & IVD Software)
Regarding the In-Vitro Diagnostic Medical Devices, around 20 devices are in the clinical chemistry category, 13 in the hematology category, 8 in the immunology category and 7 in microbiology categories including 53 IVD analyzers have been classified. CDSCO has also included potential risk classes for each device type, to ease the classification process by the manufacturer.
When a notified IVD comes equipped with software, which drives the device or influences the use of the device, the software falls automatically in the same class. Software that is not incorporated in a notified IVD medical device, shall be classified using the classification provisions as specified in paragraph 2 of Part II of the First Schedule of Medical Devices Rule 2017.
As a recap on the new medical device registration process in India, State Licensing Authorities (SLAs) have to send applications to the notified bodies for inspections and auditing of Class A and Class B category medical devices towards compliance to the MDR 2017. Class C and Class D categories are audited by the CDSCO independently as per the MDR 2017.