CDSCO Registration for Dental Medical Devices

CDSCO Registration for Dental Medical Devices (Class C and Class D)

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.

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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.

How operon can help you

When it comes to CDSCO registration for Class C and Class D dental medical devices, Operon Strategist provides complete regulatory support to manufacturers, importers, and medical device companies. Our team assists with CDSCO manufacturing and import license applications, device classification, technical documentation, Device Master File (DMF) preparation, Plant Master File (PMF) preparation, ISO 13485 compliance, regulatory gap analysis, and end-to-end submission support through the CDSCO portal. We also offer guidance for medical device registration, CE Marking, FDA compliance, quality management systems, clean room setup, and turnkey medical device manufacturing projects. With strong regulatory expertise and practical industry knowledge, Operon Strategist helps businesses simplify the licensing process and achieve faster regulatory compliance for dental medical devices in India.

FAQ

CDSCO registration is the regulatory approval process required for manufacturing, importing, and marketing dental medical devices in India. It ensures that dental devices comply with the safety, quality, and performance requirements defined under the Medical Devices Rules (MDR), 2017.

Class C and Class D dental medical devices are categorized as moderate to high-risk devices. Examples include dental amalgam, dental amalgam alloy, dental amalgam mercury, transmandibular implants, and medicated reusable dental surgical procedure kits.

Yes. From October 1, 2023, Class C and Class D dental medical devices require a manufacturing or import license under the CDSCO licensing regime as per the latest CDSCO notification.

The required documents generally include:

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