India is considered one of the leading worldwide medical device markets. Being in this position, India has made a significant change towards its device classification which made the regulatory pathways and requirements more clear. CDSCO revised the medical device classification as per the new risk-based approach under the provision of medical device rule 2017.
Applicability of reclassification on device categories
The reclassification is applicable for six broad categories which include:
- Nephrology and renal care
44 medical devices are categorized under the nephrology and renal care division, this includes some new classifications in peritoneal dialysis transfer set, peritoneal dialysis catheter, hemodialysis catheter (Long Term), and in single-needle hemodialysis catheter/ bloodlines.
- Operation theatre
In the operation theater category, 26 devices are categorized and these include the risk-based reclassification of the operation table system and surgical robotic unit.
- Pain management
Earlier the pain management category consisted of 69 devices. However, it’s re categorized into 26 devices by removing some of the devices (such as Bed/chair electric massager, cold-air therapy unit, hydrotherapy bath/tank, etc.) from the earlier list.
- Personal protective equipment
In the personal protective equipment category, 32 devices are categorized. The newly classified ones are surgical/personnel/isolation/professional examination gown, operating room shoe cover, personal protective equipment, surgical gown, and surgical cap.
- Software
The total number of devices under this category is the same as the earlier list, which is 60. It is important to look into the risk classification of devices in view of the fact that some devices have undergone a change in the risk class.
- General Hospital
The general hospital category is updated from 72 devices to 57 devices now. And it excludes automated blood cell separator, blood vacutainer, blood mixing, and blood weighing devices, blood bank pipettes, blood grouping slides, Neonatal incubator, etc. from the previous list.
CDSCO has finalized the list in consultation with stakeholders, but the organization is yet to add them to the SUGAM portal (an online portal for device registration).
The applicants who intend to furnish the application of import or manufacture under provisions of medical device rules 2017, should be well aware of their device’s classification. The new guideline will align the utilization of medical device rules with international standards to ease the manufacture, import, clinical investigation, clinical performance evaluation, sale, and distribution of medical devices. The goal is to bring India at par with the international and widely recognized standards and make the market more accessible than ever for various medical device activities. For questions or comments feel free to write to jennifer@elexes.com
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