Senior Regulatory Affairs Executive
4 Years of Experience Medical device regulatory professional specializing in EU MDR 2017/745
Registering Rehabilitation Medical Devices is vital for their safety and effectiveness. In India, the Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority overseeing this process. CDSCO approves new devices, conducts trials, sets standards, monitors imports, and collaborates with State Drug Control Organizations.
Rehabilitation medical devices are specialized tools designed to aid individuals in their recovery process following injury, illness, or medical procedures.
These devices include mobility aids, orthotic and prosthetic devices, assistive technology, rehabilitative exercise equipment, neurological rehabilitation devices, sensory aids, and communication devices.
Information About an Update on Compulsory Registration for Class C and D Medical Devices
The Central Drugs Standard Control Organization (CDSCO) has issued a circular announcing a shift in the regulatory framework for Class C and Class D (non-notified) medical devices. These devices, previously subject to mandatory registration, will now fall under a licensing system as per GSR 102(E) dated 11.02.2020. This transition will become effective from October 1, 2023.
Manufacturers and importers seeking manufacturing or import licenses for Class C and Class D medical devices must follow the Medical Devices Rules (MDR) 2017. They are advised to apply through CDSCO’s online portal, providing necessary documents and fees.
Please refer to the official circular here.
List of Class C Rehabilitation Medical Devices
Look at a couple of products categorized under Class C Rehabilitation Medical Devices –
Sr. No. | Device Name | Risk Class |
1. | Foot sensorimotor therapy mechanical neurostimulator | C |
2. | Interferential electrical stimulation system | C |
3. | Musculoskeletal/ physical therapy laser | C |
4. | Pulsed signal therapy system | C |
5. | Short-wave diathermy treatment system | C |
Please review the complete assortment of Class C Rehabilitation Medical Devices provided here.
Documents Required for CDSCO Manufacturing License of Class C and Class D Rehabilitation 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 Class D Rehabilitation Medical Devices
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 Rehabilitation Devices ?
Operon Strategist can provide comprehensive assistance with CDSCO registration for Class C and Class D rehabilitation devices. Our expertise includes guiding you through the entire registration process, from preparing the necessary documentation and application to liaising with regulatory authorities. We can help ensure your devices meet the required standards and compliance criteria. With Operon Strategist, you can streamline the registration process for CDSCO import and CDSCO manufacturing license, save you time and effort while ensuring smooth and successful registration for your rehabilitation medical devices.
Need more Clarity on Licensing Regime of Class C and Class D Rehabilitation Medical Devices? Contact us Now!
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Senior Regulatory Affairs Executive | 4 Years of Experience
Medical device regulatory professional specializing in EU MDR 2017/745 technical documentation, CE marking, risk management, clinical and biological evaluation, and post-market surveillance. His expertise includes SFDA MDMA submissions, CDSCO licensing, ISO 13485, MDSAP, US FDA regulatory requirements, and BIS certification.
