Do you want to know if a CDSCO License for dental products in India or not then look at this here is your answer. Dental products are used for dental care and treatment and are regulated in India per the Medical Devices Rules, 2017. These products contain diagnostic equipment, prosthetic devices, and dental instruments. As of October 2022, a valid CDSCO License for Dental Products in India issued by the Central Drugs Standard Control Organization (CDSCO) is essential for any company that imports, manufactures, sells, or distributes dental products.
Licensing Authorities To Get CDSCO License for Dental Products in India
Licensing Authorities For CDSCO license for Dental Products are followed by:-
- The responsible licensing authority for Class C and Class D Dental Products: The Central Drugs Standard Control Organization (CDSCO).
- The responsible licensing authority for Class A and Class B Dental Products: The State Licensing Authority in India.
A list of Class A Dental Products is followed by
- 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
A list of Class B Dental Products is followed by
- 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
- A preformed dental crown, permanent
- A preformed dental crown, temporary
- Zinc phosphate dental cement
- Dental anesthesia injection kit
- Dental anesthesia syringe, reusable
- Dental anesthesia syringe, single-use
- Dental anesthesia 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 Cement
- 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 Handpiece for Dental applications
- Orthodontic appliance, Band
- Orthopaedic dental file
The list of Class C Dental Products is followed by
- 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 anesthesia syringe cartridge
- Dental anesthesia syringe, intraligamentary
- Dental anesthesia system
Requirement To Get a CDSCO License for Dental Products in India:
- You should get the MD 5 License from the State Licensing Authority to manufacture Class A and B dental products in India.
- You should get the MD 9 License from the Central Drugs Standard Control Organization (CDSCO), which manufactures Class C dental products in India.
- You should get the MD 15 Import License from the CDSCO to import dental products into India.
Forms Required for CDSCO License for Dental Products in India:
- Form MD 5 is a License from the State Licensing Authority for Class A and Class B devices
- Form MD 9 is a License from the CDSCO for Class C devices
- Form MD 15 is an Import License from the CDSCO for Import
Cost of CDSCO License for Dental Products in India
A manufacturing license costs ₹ 5,000/- only for Class A or Class B and ₹ 500/- for each distinct device. A manufacturing license costs ₹ 50,000/- only for Class C or Class D and ₹ 1,000/- for each distinct device
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Procedure to Apply Online forCDSCO License for Dental Products in India
- Step 1: You must enroll in your organization on CDSCO’s SUGAM Portal.
- Step 2: The respective application forms must be submitted via CDSCO’s online SUGAM Portal after being filled out.
- Step 3: All the required documents must be uploaded, and then the payment must be made.
- Step 4: The CDSCO Team will investigate your application. If it satisfies all the requirements of CDSCO, it will proceed to a QMS compliance audit.
- Step 5: The Team will conduct an audit at your manufacturing premises. You must submit an NC closure report if the team identifies any Non-Conformance (NC).
- Step 6: CDSCO will issue the CDSCO license for Dental Products after all the requirements are met.
List of Documents Required for Obtaining a Dental Products Manufacturing License in India
- Organization identity proof
- Sale Deed or Rent Deed of the Premises
- Plant or Site Master File
- Building Layout with Dimension
- ISO 13485 Certificate and Previous Audit Reports
- Competent Technical Staff for Manufacturing and Devices Testing
- Device Master File
- Test License, if any
- Compliance with the environmental requirements
- Certificate of Analysis of Three Consecutive Batches
Validity and Retention of CDSCO License for Dental Products in India
The manufacturing License of Dental Products is valid indefinitely; the renewal fee must paid every five years.
What is the Deadline for Dental Products License in India?
- For Class A and Class B devices: October 1, 2022
- For Class C and Class D devices: September 30, 2023.
Is CDSCO Statutory?
India’s Central Drug Regulator CDSCO is a Statutory Agency reporting to the Ministry of Health and Family Welfare, responsible for granting Licenses for Specific drug Classes.
What is the Mandate of CDSCO?
It conforms to the safety, efficacy, and quality of drugs, cosmetics, and medical devices to safeguard and increase public health.
How Much Does an Import License Cost in India?
For IEC code registration, most import-export code agents charge an average professional fee of around ₹2000 to ₹3500, so the total cost is up to ₹4000.
What is the Drug License for Dental Products?
To manufacture Class C dental products in India, you should get the MD 9 License from the Central Drugs Standard Control Organization (CDSCO). If you want to import dental products into India, you should get the MD 15 Import License from the CDSCO.
Can a Dentist get a Pharmacy License in India?
Yes, Dentists can have both a Dentistry and pharmacy license. To obtain a Dentistry license, you must complete “A Bachelor of Dental Surgery (BDS),” and for a Pharmacy license, you must complete a Pharmacy Diploma.
What are the Classifications of Dental Products?
Dental Products can be classified into three main types according to their function: which are
1 – Preventive Dental Materials
2 – Restorative Dental Materials
3 – Auxiliary Dental Materials