Anesthesia Medical Device Registration
Introduction to Anesthesia Medical device
Anesthesia is the medical practice of inducing a reversible loss of sensation and awareness to enable painless medical procedures. This is accomplished through various methods like medications, gases, and medical devices. Anesthesia devices are essential for ensuring patient safety and comfort during procedures. They are specialized equipment that administers and monitors anesthesia, maintains vital signs, and ensures a controlled and safe experience. Anesthesia providers like anesthesiologists use these devices to manage patients undergoing surgeries or medical interventions.
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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 made changes to the regulatory framework for Class C and Class D (non-notified) medical devices. Instead of obligatory registration, these devices will now follow a licensing system outlined in GSR 102(E) dated 11.02.2020. This change will take effect from October 1, 2023.
Manufacturers and importers aiming to acquire licenses for these device categories must adhere to the Medical Devices Rules (MDR) 2017. They need to submit applications through CDSCO’s online portal, along with the necessary documents and fees.
For more detailed information, please consult the official circular provided.
List of Class C and D Anesthesia Medical Device
Check out a few of the Anesthesia Medical Device falling under Class C and Class D –
Sr. No. | Device Name | Risk Class |
1. | Anesthesia machine | C |
2. | Airway pressure/oxygen monitor | C |
3. | Pulse oximeter | C |
4. | High-frequency ventilator | C |
5. | Epidural anesthesia kit | D |
Take a moment to review all the Anesthesia Medical Devices under Class C and D, offered here for your consideration.
Documents Required for CDSCO Manufacturing License of Class C and D Anesthesia Medical Device Registration
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 Anesthesia Medical Device Registration
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 Ith Cdsco Registration for Class C and Class D Anesthesiology Medical Devices?
Operon Strategist provides comprehensive assistance for the CDSCO registration of Anesthesia Devices. Our proficiency assists you throughout the complete procedure, encompassing thorough documentation and application readiness, coupled with proficient correspondence with regulatory bodies. We guarantee the alignment of your devices with the mandatory standards and compliance benchmarks. Partnering with Operon Strategist simplifies the registration, guaranteeing a smooth process for your anesthesia devices.
Need more Clarity on Licensing Regime of Anesthesia Medical Devices? Contact us Now!
