CDSCO Registration for Dental Medical Devices for High Risk Devices
Dental Medical Device
Dental medical devices are tools, instruments, and equipment used by dental professionals to diagnose, treat, and manage various oral health conditions. These devices play a crucial role in maintaining oral hygiene, preventing dental issues, and performing dental procedures effectively. Here are some common types of dental medical devices. The Central Drugs Standard Control Organization (CDSCO), a regulatory body in India, ensures the safety, efficacy, and quality of dental medical devices by implementing stringent standards and regulations.
dental medical devices are classified based on risk into different categories, ranging from low-risk devices, such as dental mirrors and examination gloves, to higher-risk devices like dental implants, each with distinct regulatory requirements.
Looking for Consultant?
Fill the Form or Mail Us to: enquiry@operonstrategist.com
Compulsory Registration for Class C and D Medical Devices
Starting from October 1, 2023, “Class C and Class D” CDSCO Registration for Dental Medical Devices, which were previously required to be registered, will now need to follow a licensing regime as per the recent circular issued by the Central Drugs Standard Control Organization (CDSCO) on April 12, 2023. This transition aligns with GSR 102(E) dated February 11, 2020.
Manufacturers and importers seeking a manufacturing or import license for these devices should apply online via the CDSCO portal. The application process must include necessary documents and fees, following the guidelines of the Medical Devices Rules (MDR) 2017.
List of Class C and Class D Dental Medical Device
Some of the Class C and Class D Dental Medical Devices are listed below –
Sr. No. | Device Name | Risk Class |
1. | Dental amalgam | C |
2. | Dental amalgam alloy | C |
3. | Dental amalgam mercury | C |
4. | Transmandibular implant | C |
5. | Dental surgical procedure kit, medicated, reusable | C |
Examine the compilation of Class C and D Dental Medical Devices presented here.
Documents Required for CDSCO Manufacturing License of Class C and Class D Dental Medical Devices
Gaining a manufacturing license from CDSCO entails a holistic commitment to compliance, covering meticulous facility standards, methodical protocols, and exhaustive documentation. This unwavering approach guarantees the creation of medical devices that uphold rigorous benchmarks for quality and safety.
Documents Required for CDSCO Import License of Class C and Class D Dental Medical Devices
Securing a CDSCO import license necessitates obtaining Approval and Free Sale Certificates from recognized global regulatory bodies like the USA, EU, Japan, Australia, and Canada. These certificates affirm compliance with international quality standards and unrestricted market approval, underscoring their vital role in upholding safety and import quality.
When it comes to obtaining your CDSCO Registration for Dental medical devices, Operon Strategist stands as your reliable ally.
Get Expert Consultation For Medical Device Compliances
Our team of seasoned professionals excels in navigating the intricate terrain of regulatory compliance, ensuring a seamless and successful process.
Whether you’re an established industry veteran or a newcomer, we offer customized solutions to guide you through every phase of the licensing journey. With an in-depth understanding of the latest regulations and a track record of proven outcomes, Operon Strategist is dedicated to simplifying your path to securing manufacturing and import licenses.
