Dental medical devices include all the tools and equipment used by dental professionals to provide dental treatment. These devices play a vital role in treating dental issues and maintaining oral hygiene. The devices are pivotal for the dental profession. Hence, regulation of their quality, efficacy, and safety is of utmost importance. Similar to other medical devices, dental medical devices are strictly regulated worldwide to protect public health. In India, these devices are also monitored and regulated to ensure patient safety. The apex medical device regulatory body of India is Central Drugs Standard Control Organization (CDSCO). It regulates the manufacturer, sale, import, and distribution of medical devices in India. CDSCO functions under the regulatory framework of the Medical Devices Rules, 2017. Medical devices intended for dental use are also under the purview of Medical Devices Rules, 2017. For manufacturing, selling, and distributing these devices in the Indian market, CDSCO registration for dental medical devices is mandatory.

Given the impact and demand for dental medical devices, dental medical device manufacturing and distribution is a lucrative business. However, it is important to focus on the regulatory aspect before entering the Indian market. In this blog, we will focus on the mandatory CDSCO registration for dental medical devices in India.

What are dental medical devices?

Dentists use various medical devices to diagnose, treat, manage, and mitigate oral health conditions. Dental medical devices include a wide variety of equipment, tools, and instruments used for various dental procedures. Basically, the term covers dental instruments, dental diagnostic equipment, dental prosthetic devices, and other similar medical devices. Some examples are dental mirrors, scaler, probes, headlight, cement as well as dental chair, autoclaves and other sterilization equipment.

CDSCO dental medical devices classification

CDSCO has classified medical devices into four classes (A, B, C, and D) for the ease of registration and licensing. The classification helps entities understand the registration process and regulatory requirements for their products. For the purpose of CDSCO registration for dental medical devices, CDSCO has also classified the devices intended for dental use. Similar to the other medical devices, dental medical devices classification is also based on intended use and risk level.

Some examples of dental devices belonging to various CDSCO classes are as follows:

• Class A: dental cotton roll, dental dressing forceps (reusable and single use), dental suction system cannula (reusable and single use), tooth extraction forceps, dental examination kit, dental spatula (reusable and single use), dappen dish (reusable and single use), etc.
• Class B: dental anaesthesia syringe/needle, ceramic artificial teeth, dental cements, polymer based prosthodontic material, orthopaedic dental file, denture base resin, dental bone particle collector, orthodontic adhesive, endodontic sealer, dental amalgam, etc.
• Class C: transmandibular implant, transgingival implant, periodontal tissue reconstructive material, collagen dental regeneration membrane, dental surgical procedure kit (reusable and single use), dental anaesthesia system, dental bone matrix implant (animal-derived), etc.

CDSCO has published an exhaustive list of dental devices (containing approximately 95 devices) categorised based on class. The full list of CDSCO classification of medical devices intended for dental use is available here.

Licensing authorities and requirement for registering dental medical devices in India

Depending on the CDSCO class, different authorities are responsible for registration for dental medical devices.

• State Licensing Authority (SLA): SLA is responsible for Class A and B dental devices in India.
• Central Licensing Authority (CLA): CLA is responsible for Class C and D dental devices in India.

For Class A and B dental devices, MD 5 License is required. In contrast, for Class C and D dental devices, MD 9 License is required. For importing dental devices into India, MD15 Import License is required. The licenses are valid indefinitely as long as they are not cancelled by the regulatory body officials. However, a license retention fee is to be paid every five years.

Necessary documents for registration for dental medical devices

Certain supporting documents are required for registering your dental products in India.

• Sale Deed / Rent Deed proving legal ownership of the manufacturing facility.
• Building layout with dimension presenting the dimensions of each room and the location of all equipment in the manufacturing facility. This presents a detailed drawing of the medical device manufacturing facility.
• Organization identity proof, such as UDYAM Aadhar, PAN card, etc.
• Documents proving the manufacturing team comprises competent, qualified, and experienced staff who will manufacture and test the dental devices.
• Plant master file
• Device master file
• Audit reports
• ISO 13485 Certificate validating the manufacturing facility meets international criteria for quality management systems.
• Medical device test license. This will be required in case you need to test your dental product before launching it in India.
• Certificate of Analysis of 3 Consecutive Batches. This document will certify that the first 3 batches of the manufactured dental devices meet the required quality benchmarks.
• Document supporting compliance with the environmental regulatory requirements.

The above list provides an outline of the supporting documents. For the exact list of documents and document preparation support, the Pharmadocx Consultants team is ready to help you.

Process for registration for dental medical devices

The application process for registration for dental medical devices in India is online on the CDSCO website.

1. Login/Signup on CDSCO’s online registration portal, SUGAM.
2. Prepare the application as per the requirements of the CDSCO dental medical device class.
3. Collate the necessary supporting documents required for registration.
4. Submit the application online and pay the required registration fees.
5. The regulatory officials will review and evaluate your application.
6. The regulatory officials will perform an audit and inspect the manufacturing facility as per regulatory requirements.
7. If all the necessary criteria are fulfilled, CDSCO will grant the pertinent license. This will permit you to manufacture, sell, and distribute dental medical devices in India.

Registering dental medical devices in India: Pharmadocx Consultants your trusted ally

With an in-depth understanding of the CDSCO regulations, Pharmadocx Consultants is dedicated to simplifying your path to securing registration for dental medical devices in India. We leverage our expertise and industry knowledge to help medical device manufacturers obtain medical device manufacturing, test, and import license.

Documentation support: Different classes of dental devices have different documentation requirements. We will help you prepare the necessary documents for registering your dental products in India.

License application support: We will oversee the complex license application process. Our team has proven expertise in license application.  

Mock audit support: Pharmadocx Consultants conducts mock audits to help their clients identify any noncompliance or shortcomings. Our mock audit service will prepare you for the inspection and audit carried out by the regulatory officials. Additionally, we provide audit document preparation support.

License grant support: Our service does not end with assistance for registration application. We provide license application and document preparation support as well as assist in procuring the license. Our team of experts will help you respond to any query raised by the officials. We will monitor the application process till the license is granted.

Manufacturing medical devices intended for dental use is a potential business. However, to enter the Indian medical device manufacturing sector, you have to register your product with the CDSCO. The Pharmadocx Consultants team will help you obtain the registration for dental medical devices in India. Our team provides tailored support depending on your needs and will guide you through the steps of the registration process. Call/Whatsapp us at 9996859227 or drop an email at [email protected] and let us be your trusted ally in the dental device registration process.