CDSCO Updates Classification List for Four Medical Device Categories, Invites Stakeholder Feedback
The Central Drugs Standard Control Organisation (CDSCO) has announced an updated classification list for medical devices, spanning four categories: interventional radiology, radiotherapy, oncology, and Class A (non-sterile and non-measuring) medical devices. This revision follows the Medical Device Rules (MDR), 2017, as well as internationally accepted standards.
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Dr. Rajeev Singh Raghuvanshi, Drugs Controller General, stated, “The existing classification lists have been revisited, and new entries have been added in line with the First Schedule (Part I) of the MDR, 2017, as well as international classification standards. These include categories such as interventional radiology, radiotherapy, oncology, and Class A devices.
Updated Classification Categories
The revised classification list includes the following four categories:
- Interventional Radiology
- Radiotherapy
- Oncology
- Class A (Non-Sterile and Non-Measuring) Medical Devices
The classification follows a risk-based approach as outlined in Rule 4(3) of Chapter II of the MDR, 2017.
For More Details On CDSCO Updated Medical Device Classification
Key Devices and Their Risk Classification
- Interventional Radiology:
- 186 devices in total, with:
- Class C: Angiography devices, cardiovascular MRI systems, full-body MRI systems.
- Class B: Ultrasound and x-ray related devices.
- Class A: Grid for MRI (needle guide positioner).
- Radiotherapy:
- 114 devices listed, including:
- Class D: Gamma knife for radiotherapy.
- Class C: Brachytherapy devices.
- Oncology:
- 75 devices listed, including:
- Class C: Accelerator systems, cancer diagnostic probes.
- Class B: Breast ultrasound imaging system, facial prosthesis.
- Class A (Non-Sterile and Non-Measuring) Devices:
- 803 devices listed, such as abdominal support belts, absorbent cotton wool, acupressure bands.
Stakeholder Feedback Requested
The CDSCO is requesting stakeholders to review the updated list and submit their feedback within 30 days of its publication. Comments can be submitted via the provided feedback form, which is part of the notice released by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General.
Importance of the Update
This updated classification list aims to ensure that medical device regulations are aligned with both national and international standards. It is expected to improve regulatory clarity and streamline the approval process for medical devices.
Feedback Submission
Stakeholders wishing to participate in the feedback process can find the draft list and feedback form on the CDSCO website. All comments must be submitted by the deadline to be considered for finalization.
For more information on CDSCO medical device registration, stakeholders are encouraged to visit the CDSCO official website or contact the relevant regulatory authority.
