Mandatory CDSCO License for Dental Products in India
Dental products, a broad range of specialized products used for dental care and treatment, are regulated under the Medical Devices Rules, 2017 in India. This includes dental instruments, diagnostic equipment, and prosthetic devices and many more. As of October 2022, a valid license from the Central Drugs Standard Control Organization (CDSCO) is mandatory for any entity that engages in the manufacturing, importation, sale, or distribution of dental products in India.
Licensing authorities for Dental Products in India
The Central Drugs Standard Control Organization (CDSCO) is the licensing authority for Class C and Class D dental devices and the State Licensing Authority is the licensing authority for Class A and Class B dental devices in India.
List of “Class A” Dental Products
- Dental impression material
- Dental collar/crown scissors
- Dental excavator, reusable
- Dental excavator, single-use
- Dappen dish, reusable
- Dappen dish, single-use
- Dental examination kit
- Dental material mixing surface, reusable
- Dental material mixing surface, single-use
- Dental spatula, reusable
- Dental spatula, single-use
- Dental impression material kit, reusable
- Dental impression material kit, single-use
- Dental impression material mixer
- Dental impression material syringe
- Dental impression tray material
- Dental impression tray, reusable
- Dental polishing brush
- Dental suction system cannula, reusable
- Dental suction system cannula, single-use
- Dental suction system fluid-separation unit
- Bar dental precision attachment
- Dental cotton roll
- Dental impression tray, single-use
- Dental articulation paper forceps
- Dental dressing forceps, reusable
- Dental dressing forceps, single-use
- Rubber dam clamp forceps
- Tooth extraction forceps
- Dental amalgam mercury dispenser
- Bite registration rim wax
- Oral Cavity Abrasive Polishing Agent
- Orthodontic Elastomeric
List of “Class B” Dental Products
- Dental crown, polymer
- Dental crown/bridge resin, temporary
- Dental crown/bridge, temporary
- Dental crown, metal/ceramic
- Dental crown, metal/polymer
- Dental bone particle collector
- Dental suction system
- Carboxymethylcellulose sodium denture adhesive
- Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free
- Dental amalgam
- Dental suction system pump
- Dental suction system disinfection control unit
- Zinc polycarboxylate dental cement
- Preformed dental crown, permanent
- Preformed dental crown, temporary
- Zinc phosphate dental cement
- Dental anaesthesia injection kit
- Dental anaesthesia syringe, reusable
- Dental anaesthesia syringe, single-use
- Dental anaesthesia syringe/needle
- Bite registration rim
- Bite registration rim wax, plate
- Calcium hydroxide dental cement
- Ceramic artificial teeth
- Dental Bonding Agents
- Dental Etchant
- Dental Prosthesis Priming Agent
- Restorative Material
- Orthodontic Adhesive
- Dental Varnishes/ Glazing
- Dental Cements
- Dental Root Surface Conditioner
- Dental Cleansing Solution
- Endodontic Sealer
- Root Canal Filling removal Solution
- Dental Composite Resin Kit
- Gingival Bleaching Protector
- Dental Caries Removal Solution
- Denture Base Resin
- Polymer Based Prosthodontic Material
- Powered Surgical Drill Hand piece for Dental applications
- Orthodontic appliance, Band
- Orthopaedic dental file
List of “Class C” Dental Products
- Dental bone matrix implant, animal-derived
- Temporary mandibular condyle prosthesis
- Temporomandibular joint disc
- Transgingival implant
- Transmandibular implant
- Pliable-polymer dental regeneration membrane, bio absorbable, ligated
- Pliable-polymer dental regeneration membrane, bio absorbable, tacked
- Dental surgical procedure kit, medicated, reusable
- Dental surgical procedure kit, medicated, single-use
- Membrane fixation tack, bio absorbable
- Periodontal root surface regeneration material
- Periodontal tissue reconstructive material
- Bone matrix implant, human-derived
- Collagen dental regeneration membrane
- Dental anaesthesia syringe cartridge
- Dental anaesthesia syringe, intraligamentary
- Dental anaesthesia system
Are You Looking for a License to Manufacture Dental Products in India?
Contact MedDev Experts today! We have a team of experienced professionals who can help you navigate the complex regulatory process and get your license approved.
Dental Products Licensing Requirement:
- To manufacture Class A and Class B dental products in India, you must obtain the MD 5 License from the State Licensing Authority.
- To manufacture Class C dental products in India, you must obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO).
- To import dental products into India, you must obtain the MD 15 Import License from the CDSCO.
Requirements for Manufacturing, Importing, and Distributing Dental Products in India:
- Class A and Class B devices: MD 5 License from the State Licensing Authority
- Class C devices: MD 9 License from the CDSCO
- Import: MD 15 Import License from the CDSCO
License Fee for Dental Products in India
- Class A or Class B: ₹ 5,000/- for manufacturing license, ₹ 500/- for each distinct device.
- Class C or Class D: ₹ 50,000/- for manufacturing license, ₹ 1,000/- for each distinct device.
Validity of Dental Products License in India
Dental product licenses are valid indefinitely, as long as the retention fee is paid every 5 years.
How to Apply Online for Dental Products Manufacturing or Import License in India
- Step 1: Enroll your organization on CDSCO’s SUGAM Portal.
- Step 2: Fill in the respective applications and submit them through CDSCO’s online SUGAM Portal.
- Step 3: Upload the necessary documents and make the required payment.
- Step 4: Your application will be scrutinized by the CDSCO Team. If it meets the requirements, it will proceed to a quality management system compliance audit.
- Step 5: The Team will conduct an audit at your manufacturing premises. If any Non-Conformance (NC) is identified, you will be required to submit an NC closure report.
- Step 6: Once all the conditions are met, CDSCO will grant the license.
Deadline for Obtaining Dental Products License in India
The deadline for obtaining dental products license in India is October 1, 2022 for Class A and Class B devices, and September 30, 2023 for Class C and Class D devices.
List of Documents for Obtaining an Dental Products Manufacturing License in India
- Organization identity proof: This could be the Memorandum of Association, List of Directors or Partners, UDYAM Aadhar, or PAN card.
- Sale Deed / Rent Deed of the Premises: This document proves that you have legal ownership of the premises where you will be manufacturing the medical devices.
- Plant or Site Master File: This file contains information about the layout of your manufacturing facility, as well as the equipment and processes you will be using.
- Building Layout with Dimension: This is a detailed drawing of your manufacturing facility, showing the dimensions of each room and the location of all equipment.
- ISO 13485 Certificate and Previous Audit Reports: This certificate shows that your manufacturing facility meets international standards for quality management systems.
- Competent Technical Staff for Manufacturing and Testing of Devices: You must have a team of qualified and experienced staff who can manufacture and test your medical devices.
- Device Master File: This file contains detailed information about each medical device you will be manufacturing, including its design, manufacturing process, and testing procedures.
- Test License, if any: If you need a license to test your medical devices, you must obtain it before you can start manufacturing them.
- Compliance with the environmental requirements: You must comply with all applicable environmental regulations, such as those related to cleanrooms for manufacturing the devices.
- Certificate of Analysis of 3 Consecutive Batches: This certificate shows that the first 3 batches of medical devices you manufactured meet the required quality standards.
