Introduction to Oncology Medical Devices
The field of oncology devices is at the forefront of medical innovation, focusing on tools designed to diagnose, treat, and manage various forms of cancer. From advanced imaging technologies that aid in early detection to precision radiotherapy devices that target tumors with unprecedented accuracy, the oncology device category plays a pivotal role in improving patient outcomes. They improve cancer care, boosting diagnosis, treatment efficiency, while minimizing side effects and enhancing patients’ quality of life.
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Information About an Update on Compulsory Registration for Class C and D Medical Devices
The Central Drugs Standard Control Organization (CDSCO) has introduced changes to the regulatory Sr. No. framework for Class C and Class D (non-notified) medical devices. Instead of mandatory registration, these devices will now adhere to a licensing system outlined in GSR 102(E) dated 11.02.2020. This transition is effective from October 1, 2023.
Manufacturers and importers intending to obtain licenses for these classes of devices must adhere to the Medical Devices Rules (MDR) 2017. They are required to submit applications through CDSCO’s online portal along with the requisite documentation and fees. For detailed information.
Please refer to the official circular provided.
List of Class C and D Oncology Medical Devices
Kindly assess a couple of Class C and Class D categorized Oncology medical devices listed below.
Sr. No. | Device Name | Risk Class |
1. | Activated-oxygen generator | C |
2. | Electro cancer therapy system | C |
3. | Brachytherapy source spacer | C |
4. | Flexible ultrasound colonoscope | C |
5. | Extravascular-circulation hyperthermia system | D |
Kindly review the full range of Class C and D Oncology Medical Devices provided here
Documents Required for CDSCO Manufacturing License of Class C and D Oncology Medical Devices
Obtaining a CDSCO manufacturing license involves a comprehensive dedication to adherence, encompassing precise facility requirements, systematic procedures, and thorough record-keeping. This steadfast strategy ensures the development of medical devices that consistently meet stringent standards for both quality and safety.
Documents Required for CDSCO Import License of Class C and D Oncology Medical Device
Acquiring a CDSCO import license requires obtaining Approval and Free Sale Certificates from well-known international regulatory authorities such as the USA, EU, Japan, Australia, and Canada. These certificates validate adherence to global quality standards and unrestricted market acceptance, underscoring their crucial role in ensuring safety and import excellence.
How Can Operon Strategist Help You With CDSCO Registration for Class C and Class D Oncology Medical Devices?
Operon Strategist offers comprehensive support for CDSCO registration of Oncology Devices. Our expertise guides you through the entire process, including meticulous documentation and application preparation, along with effective communication with regulatory authorities. We ensure your devices align with the required standards and compliance criteria. Collaborating with Operon Strategist streamlines registration, ensuring a seamless process for your oncology devices.
Need more Clarity on the Licensing Regime of Class C and Class D Oncology Medical Devices? Contact us Now!
