Obtain CDSCO approval for dental medical devices and products in India with UMSPCS. Expert assistance for registration, licensing, documentation, import, manufacturing, and regulatory compliance.
CDSCO Certification for Dental Products
CDSCO Certification for Dental Products
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CDSCO Certification for Dental Products in India | Expert Compliance Support
There is rapid growth and development in the Indian dental industry with increasing needs of dental equipment, restorative products, orthodontic products, dental implants, and diagnostic aids. However, it is very important to abide by the relevant regulations stipulated under the Medical Devices Rules, 2017 to manufacture, import, distribute, and sell any dental product in India.
If you are a manufacturer, importer, distributor, or a startup firm launching new dental products in India, then obtaining a CDSCO Certification for Dental Products is a key thing to be done by you.
CDSCO (Central Drugs Standard Control Organization) controls the medical devices in India with an aim to ensure that safe and effective medical devices alone are provided to health care professionals as well as patients in India. Approval can be obtained from SLA (State Licensing Authority) or CDSCO (Central Licensing Authority) depending on the risk categorization of the dental product concerned.
UMSPCS takes the complete burden of compliance journey from the identification of proper device categorization to the submission of the application through the CDSCO SUGAM portal.
What is CDSCO Certification for Dental Products?
CDSCO Certification of Dental Products involves the licensing process that is mandatory for dental medical devices prior to manufacture, import, marketing, and sale in India. This certification assures that the dental devices meet the safety, quality, and performance criteria set out in the Medical Devices Rules, 2017.
The products used in dentistry are classified as medical devices owing to their direct effects on the well-being of patients and the resultant clinical outcome. These products comprise:
- Dental instruments
- Orthodontic devices
- Dental implants
- Restorative materials
- Dental consumables
- Dental diagnostic equipment
- Dental surgical instruments
- Prosthetic devices
The competent licensing agency varies depending on the risk category of the device. It is essential to obtain the necessary license before commercializing the products in India.
Why is CDSCO Certification Mandatory for Dental Products?
Unlike other consumer goods, dental equipment is employed in diagnostic and therapeutic processes. In any case of fault in such products, there may be a direct risk to the patient's safety and treatment process.
CDSCO Certification for Dental Products guarantees:
- Regulatory compliance in India
- Patient safety and efficacy of the product
- Market approval before distribution
- Higher patient trust
- Manufacturing and importation according to law
- Low regulation risks
- Customs clearance of imported equipment
Regulatory Framework Governing Dental Products in India
Regulation of dental products occurs in accordance with:
- Medical Devices Rules, 2017
- Drugs and Cosmetics Act, 1940
- Guidelines from the Central Drugs Standard Control Organization (CDSCO)
- Risk-based classification system for medical devices
As per these regulations, each dental medical device should be categorized in accordance with its purpose and associated risk before applying for registration or licensing.
The licensing body and the procedure vary on the basis of the category - Class A, Class B, Class C, and Class D.
Licensing Authorities for Dental Products in India
The approval authority depends on the device classification.
Device Class | Licensing Authority |
Class A | State Licensing Authority (SLA) |
Class B | State Licensing Authority (SLA) |
Class C | Central Drugs Standard Control Organization (CDSCO) |
Class D | Central Drugs Standard Control Organization (CDSCO) |
Usually:
- Low-risk products come under the purview of the State Licensing Authority
- Moderate risk, high-risk, and critical products must get approval from CDSCO
The knowledge of the appropriate licensing body is the very first step to get CDSCO certification in India.
Dental Products Covered Under CDSCO Certification
Many kinds of dental medical products are needed to be approved before launching in the Indian market.The major classifications are as follows:
- Preventive Dental Products
- Restorative Dental Products
- Orthodontic Products
- Dental Surgical Products
- Endodontic Products
- Dental Diagnostic Equipment
- Dental Consumables
Official Classification of Dental Products under CDSCO
Pursuant to the Medical Device Rules, 2017, the Central Drugs Standard Control Organization (CDSCO) has classified the dental medical devices according to their usage and risk associated with them. The classification of these medical devices will determine the licensing agency and its requirements for each individual product.
| S.No. | Medical Device Name | Intended Use | Risk Class |
| 1 | Dental impression material | This material is primarily used to take an oral impression. | A |
| 2 | Dental collar/crown scissors | Scissors are used to cut delicate tissue to remove sutures to perform precision procedures. | A |
| 3 | Dental excavator, reusable | It is a device intended to cut, clean out and shape a carious cavity before filling it. | A |
| 4 | Dental excavator, single-use | It is a single use device intended to cut, clean out and shape a carious cavity before filling it. | A |
| 5 | Dappen dish, reusable | It is a small bowl used to mix and hold dental materials. These dishes can be disposable or reusable | A |
| 6 | Dappen dish, single-use | A small, shallow concave vessel used to knead and hold dental materials. | A |
| 7 | Dental examination kit | Intended as a kit for dental examination. | A |
| 8 | Dental crown, polymer | A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific patient, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. | B |
| 9 | Dental crown/bridge resin, temporary | A material used to manufacture crowns and bridges. | B |
| 10 | Dental crown/bridge, temporary | Intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated. | B |
| 11 | Dental material mixing surface, reusable | A dental instrument slab or tray used as a surface to mix dental materials. | A |
| 12 | Dental material mixing surface, single-use | It has a pad or tray used to knead or mix dental material (impression material, cement, etc). | A |
| 13 | Dental spatula, reusable | A dental instrument used to mix dental materials. Some are equipped with an injection function. | A |
| 14 | Dental spatula, single-use | A spatula-shaped device used to knead or mix dental material (impression material, cement, etc). | A |
| 15 | Dental crown, metal/ceramic | A device made of a combination of metal and tooth-coloured ceramic, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. | B |
| 16 | Dental crown, metal/polymer | A device made of metal, veneered with a polymer-based, tooth-coloured material, and created for a specific patient, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. | B |
| 17 | Dental impression material kit, reusable | Devices and materials used to take the impression. | A |
| 18 | Dental impression material kit, single-use | A collection of non-sterile devices designed to obtain a negative imprint of the teeth. The kit typically includes dental impression materials and a dental impression tray(s); This is a single-use device. | A |
| 19 | Dental impression material mixer | An electric device used to mix impression materials immediately before use at the chair side. | A |
| 20 | Dental impression material syringe | This dental injection syringe is used to inject the impression material onto the impression tray. | A |
| 21 | Dental impression tray material | A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The material is used in cases in which a preformed The impression tray is not suitable. | A |
| 22 | Dental impression tray, reusable | An impression tray is a metal or plastic device intended to hold impression material, to make an impression of a patient's teeth to reproduce the structure of a patient's teeth. | A |
| 23 | Dental polishing brush | A rotary dental brush intended for cleaning and polishing by a dental hygienist or a dentist. | A |
| 24 | Dental bone particle collector | A device used to collect bone debris generated by drilling, etc. during oral surgery. | B |
| 25 | Dental bone matrix implant, animal-derived | A sterile bio absorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. | C |
| 26 | Dental suction system | It evacuate solids, liquids, aerosols and gases from the oral cavity and immediate surrounding area for the purpose of improving operating effectiveness and efficiency during oral treatment procedures and limiting the contamination of the immediate environment. | B |
| 27 | Dental suction system cannula, reusable | A tubal dental device to be connected to a non-active aspiration device (usually, a dentistry dedicated device). Used to eliminate water and cutting debris that have accumulated in the oral cavity. This device is reusable after sterilization. | A |
| 28 | Dental suction system cannula, single-use | A tubal dental device to be connected to a non-active aspiration device (usually, a dentistry dedicated device). Used to eliminate water and cutting debris that have accumulated in the oral cavity. | A |
| 29 | Carboxymethylcellulose sodium denture adhesive | An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. | B |
| 30 | Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free | An adhesive compound intended to be used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. | B |
| 31 | Dental amalgam | A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). | B |
| 32 | Dental suction system fluid-separation unit | A separator used in the oral cavity. Used for the separation of fluids (saliva, blood) from gases to avoid liquids from entering the suction pump (i.e., dry suction). | A |
| 33 | Dental suction system pump | An electrically-powered dental suction pump used as the suction source of a dental suction system, dental treatment unit, etc. | B |
| 34 | Temporary mandibular condyle prosthesis | A sterile implantable device intended for the temporary reconstruction of the mandibular condyle of the temporomandibular joint (TMJ) typically in a patient undergoing ablative surgery requiring the removal of the mandibular condyle. | C |
| 35 | Temporomandibular joint disc | A sterile interpositional implant or interarticular disc, intended to permanently interface between the natural mandibular condyle and natural glenoid fossa (mandibular fossa) in the temporomandibular joint (TMJ). | C |
| 36 | Bar dental precision attachment | It connects removable partial dentures to fixed bridgework under a male/female locking mechanism. | A |
| 37 | Dental suction system disinfection control unit | An electrically-powered device intended to control the regular (typically daily) automated/semi-automated disinfection of a dental suction system tubing line. | B |
| 38 | Transgingival implant | A sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis. | C |
| 39 | Zinc polycarboxylate dental cement | A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). | B |
| 40 | Transmandibular implant | A sterile transosteal (transosseous) device [transmandibular implant (TMI)] intended to be surgically implanted through mandibular bone to provide support and a means of retention for a dental prosthesis, especially in a patient with an extremely atrophied/deformed mandible. | C |
| 41 | Pliable-polymer dental regeneration membrane, bio absorbable, ligated | A sterile bio absorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. | C |
| 42 | Pliable-polymer dental regeneration membrane, bio absorbable, tacked | A sterile bio absorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. | C |
| 43 | Dental surgical procedure kit, medicated, reusable | A collection of various dental instruments, dressings, pharmaceuticals and the necessary materials used to perform a dental surgical procedure. | C |
| 44 | Dental surgical procedure kit, medicated, single-use | A collection of various sterile dental instruments, dressings, pharmaceuticals and the necessary materials used to perform a dental surgical procedure. | C |
| 45 | Membrane fixation tack, bio absorbable | A sterile bio absorbable tack intended to be used to fix a pliable-polymer dental regeneration membrane in situ to aid in the regeneration of tooth support that has been lost due to periodontal disease or trauma. | C |
| 46 | Periodontal root surface regeneration material | A bio absorbable material intended to be used alone or in combination with bone graft materials for the regeneration of tooth support that has been lost due to periodontal disease or trauma. It is applied during periodontal flap surgery to the scaled and preconditioned root surface and forms an insoluble matrix that creates a suitable root surface for selective periodontal cell migration and cell attachment, which re-establishes the lost tooth support. | C |
| 47 | Periodontal tissue reconstructive material | A sterile viscous material intended to be injected into the buccal mucosa to treat deficiencies of the gingiva (e.g., interdental papillae), through augmentation, during the treatment of intermediate stage periodontal disease. | C |
| 48 | Bone matrix implant, human-derived | A sterile implantable device made primarily of human demineralized bone matrix (DBM) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. | C |
| 49 | Collagen dental regeneration membrane | A sterile, bio absorbable, animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and/or to regenerate bone or bone defects around dental implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. | C |
| 50 | Dental cotton roll | It is intended as an absorbent, hard-packed cylinder (a roll) that is used as a saliva absorber from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. | A |
| 51 | Dental impression tray, single-use | The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device. | A |
| 52 | Preformed dental crown, permanent | A prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure. | B |
| 53 | Preformed dental crown, temporary | This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury. | B |
| 54 | Zinc phosphate dental cement | A non-sterile substance intended for professional use as a dental cement and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the principal constituent of which is zinc oxide (ZnO)] and an aqueous solution of phosphoric acid. | B |
| 55 | Dental articulation paper forceps | A hand-held manual dental instrument designed for grasping and holding articulation paper during its application to a patient's oral cavity. | A |
| 56 | Dental dressing forceps, reusable | A hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. | A |
| 57 | Dental dressing forceps, single-use | A sterile, hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. | A |
| 58 | Rubber dam clamp forceps | A hand-held dental instrument used for the insertion and removal of rubber dam clamps. | A |
| 59 | Tooth extraction forceps | A hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. | A |
| 60 | Dental amalgam mercury dispenser | A device with a valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form which is to be used to produce amalgam filling material. | A |
| 61 | Dental anaesthesia injection kit | A collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. | B |
| 62 | Dental anaesthesia syringe cartridge | A plastic or glass container prefilled with a single dose of anaesthetic medication intended to be inserted into a dental anaesthesia syringe and injected into oral tissues for a dental procedure. | C |
| 63 | Dental anaesthesia syringe, intraligamentary | A hand-held manual dental instrument intended to be used to inject an anaesthetic agent under pressure via the periodontal ligament or into bone through an attached sterile needle. This is a reusable device. | C |
| 64 | Dental anaesthesia syringe, reusable | A hand-held manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. | B |
| 65 | Dental anaesthesia syringe, single-use | A sterile, hand-held, manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle (needle not included). | B |
| 66 | Dental anaesthesia syringe/needle | A hand-held manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an included sterile needle; the needle may be attached or detached. | B |
| 67 | Dental anaesthesia system | An assembly of devices used for the administration of a proportional mixture of oxygen (O2) and nitrous oxide (N2O) or medical air during dental surgical treatment. | C |
| 68 | Bite registration rim | A schematic model of the dental arch attached to a temporary or permanent base for recording jaw relationships. | B |
| 69 | Bite registration rim wax | A dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device. | A |
| 70 | Bite registration rim wax, plate | A dental material (modelling wax) delivered as prefabricated plates of wax with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). | B |
| 71 | Calcium hydroxide dental cement | Use as a dental cement and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid. | B |
| 72 | Ceramic artificial teeth | Prefabricated teeth made of ceramic (porcelain) for mounting on removable dentures or fixed partial dentures. | B |
| 73 | Dental soft-tissue matrix implant, animal-derived | A sterile, bio absorbable, animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue ingrowth; it is indicated for various oral soft tissue augmentation procedures (e.g., alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material which may be fixed to soft tissues with sutures; it is applied to soft tissue during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device. | C |
| 74 | Dental Bonding Agents | A dental resin used in the bonding of light cured composites and acid modified composites to tooth structure. | B |
| 75 | Dental Etchant | The material is applied for temporary etching of dental hard tissue in order to condition the surface for bonding procedures. | B |
| 76 | Dental Prosthesis Priming Agent | A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) immediately prior to insertion into a tooth structure to promote bonding to a prosthesis component during a dental procedure in the mouth. | B |
| 77 | Restorative Material | A dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material for restoration of cavities in teeth. | B |
| 78 | Orthodontic Adhesive | Used as a combined etchant and primer in orthodontic treatment used with/without light curing direct bonding orthodontic adhesive. | B |
| 79 | Dental Varnishes/ Glazing | A dental device intended to be applied to the surface of a restorative dental filling to attain a smooth, glaze-like finish on the surface. | B |
| 80 | Dental Cements | Intended for direct/indirect restoration (temporary/permanent) of tooth. | B |
| 81 | Dental Root Surface Conditioner | Assists in the debridement and cleaning of root canals (dental) Aids in the chemical breakdown of pulp soft tissue (dental). | B |
| 82 | Dental Cleansing Solution | A liquid used to clean cavities or root canals after preparation, and may also be used for disinfecting the cavity or root canal in endodontic procedures. | B |
| 83 | Endodontic Sealer | To fill and seal all pathways between the root canal and external surfaces of the tooth i.e., for permanent obturation of the root canal. Intended for use in procedure involving root filling, repair of root perforations, pulp capping and apexification. | B |
| 84 | Oral Cavity Abrasive Polishing Agent | An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. | A |
| 85 | Root Canal Filling removal Solution | A liquid substance used in endodontic procedures for the softening and removal of root canal fillings. It will typically be introduced into the root canal using instruments. The device typically contains solvents and other elements (e.g., tetrachloroethylene, formamide, eucalyptol, excipients). | B |
| 86 | Dental Composite Resin Kit | A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin based cement nor dental prosthesis. | B |
| 87 | Gingival Bleaching Protector | A non-sterile paste or gel-like substance designed to protect a patient's gums from the hydrogen peroxide (H2O2) found in teeth whitening agents used during chairside light-curing bleaching of the teeth. | B |
| 88 | Dental Caries Removal Solution | A liquid substance used in dentistry to detect and remove caries from an infected tooth. | B |
| 89 | Denture Base Resin | A collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). | B |
| 90 | Polymer Based Prosthodontic Material | Light cured, methacrylate-based resin for creating reservoir space for bleaching trays is useful for laboratory procedures such as model, and die repair. It can block out defects and under cuts on the stone models quickly and securely for precise abutment preparation. | B |
| 91 | Powered Surgical Drill Hand piece for Dental applications | A device that consists of a hand piece to which is connected a variety of attachments in order to achieve a number of cutting/inserting/trimming operations. | B |
| 92 | Orthodontic appliance, Band | Device for fixed orthodontic appliances. Device affixed to contour of tooth/teeth and cemented into place to support (pressure can be exerted on the teeth) orthodontic appliances or attachments. | B |
| 93 | Orthodontic Elastomeric | A tooth positioner/instrument intended to control settling/position and to minimize or eliminate relapse of the teeth after an orthodontic treatment. | A |
| 94 | Orthopaedic dental file | A hand-held dental surgical instrument used to enlarge the root canal, smooth out the root canal wall or shaping canals after they are previously cleaned by scratching/scraping with vertical reciprocating motion or rotary motion or plucking motion. | B |
| 95 | Dental endodontic enlarger | A device for enlarging and preparing the root canal, which probes, enlarges, and cleans the root canal by dental file, etc. The motion of the file includes vibrating, rotating, repeating rotation, reciprocating, and a combination of these motions. | B |
Key Aspects of CDSCO Certification for Dental Products
CDSCO Certification for Dental Products requires more than just making an application. Manufacturers or importers have to prove that their dental products are regularly meeting regulatory requirements in terms of safety, quality, and performance.These are some of the most important considerations:
- Proper classification of medical devices
- Licensing authority of the product
- Adherence to Medical Devices Rules, 2017
- Device Master File (DMF) preparation
- Plant Master File (PMF) preparation
- Quality Management System (ISO 13485)
- Performance assessment of the product
- Review of technical documentation
- Manufacturing facilities audit
Eligibility Requirements for CDSCO Certification for Dental Products
In order to apply for CDSCO certification of dental products, it is necessary that one meets the eligibility conditions as defined under Medical Devices Rules, 2017. The eligibility would depend upon the category of the person who applies for CDSCO certification and that may be an Indian Manufacturer, Foreign Manufacturer, Importer or Authorized Representative.
Those entities who are eligible to apply for CDSCO certification in India include:
- Indian manufacturers of dental products
- Foreign Manufacturers of dental products who export their products to India
- Authorized Indian Agent (Foreign Manufacturer)
- Importers of dental devices
- Owners of brands of dental products
- Distributors of medical devices
It is essential for foreign manufacturers to nominate an Authorized Indian Representative (AIR).
Basic Requirements for CDSCO Certification for Dental Products
It is imperative to meet these requirements to get regulatory clearance. Prior to filing the application, companies must ensure that the following requirements are met:
- Product Classification
- Quality Management System (QMS)
- Manufacturing Facility
- Technical Documentation
- Device Master File (DMF)
- Plant Master File (PMF)
- Regulatory Compliance
Applicable Licenses and Forms for Dental Products
The application form that must be used will be based on the activity type and risk class of the device.
Selecting the proper application form is among the most crucial stages during the CDSCO Medical Device Registration procedure.
| Purpose | Applicable Form |
| Manufacturing License for Class A & B | Form MD-5 |
| Manufacturing License for Class C & D | Form MD-9 |
| Import License for Medical Devices | Form MD-15 |
Complete Procedure for CDSCO Certification for Dental Products
CDSCO certification in India follows a systematic process of regulation. The following sequence will ensure that there is no delay and any compliance problem.
Step 1: Register Company on CDSCO SUGAM Portal
It is mandatory for the applicant to register the company on the CDSCO SUGAM portal through providing the requisite details about the business and the applicant to start the CDSCO Certification for Dental Products procedure.
Step 2: Make the Application
Make the relevant application form of CDSCO containing all the information related to dental products like their intended use, manufacture details and other details as per the regulatory requirements.
Step 3: Provide All the Relevant Documents
All the required documents have to be provided like DMF, PMF, ISO 13485 Certificate, Product Test Reports, Technical Specifications, Labeling and other documents.
Step 4: Payment of Applicable Government Fees
Applicable government fees are paid depending upon the classification of device, type of application either manufacturing/import and the number of dental products in the application.
Step 5: CDSCO License Grant
The licensing authority evaluates the application and other documentation. If the process goes well, the CDSCO manufacturing license is granted for manufacturing/import/selling and distributing dental products in India.
Documents Required for CDSCO Certification for Dental Products
It is important to have complete and proper documentation to avoid any regulatory hurdles. Though different types of documentation may be needed based on classification of devices and nature of applications, some of the most common ones include:
- Proof of organization’s identity
- Rent Deed of premises
- Master File of Plant/Site
- Dimensioned Building Layout
- ISO 13485 certificate and previous audit reports
- Technical manpower competent for manufacturing and devices testing
- Device master file
- Test license if available
- Compliance with environmental requirements
- Certificate of analysis of three consecutive batches
With complete documentation, chances of getting the CDSCO certification for dental products become much easier.
Cost of CDSCO Certification for Dental Products
For Class A and Class B, the license fee for manufacture is only ₹ 5,000/- and for each separate apparatus, it is ₹ 500/-. For Class C and Class D, the fee for manufacture is ₹ 50,000/- and for each separate apparatus, it is ₹ 1,000/.
Other charges will occur for laboratory testing, audits, document preparation, and regulatory consultancy based on the nature of the application.
Estimated Timeline for CDSCO Certification
Review Time Frame is dependent on the nature of the classification, complexity, and completeness of the documents submitted and usually runs as follows:
- Class I Low Risk Devices: 3-6 months
- Class III Higher Risk Implantable Devices: 6-12 months or longer
Issues That Could Delay Review
- Incompleteness of documents
- Requesting further information
- Testing delays
- Questions posed during the review process
Common Challenges in Obtaining CDSCO Certification
Most companies face delays due to preventable compliance problems, some of which may be listed below:
- Product classification errors
- Documentation problems
- Device Master File or Plant Master File errors
- Non-submission of test reports
- Delay in responding to queries from regulators
- Violation of ISO 13485 guidelines
- Labeling and packaging mistakes
- Lack of knowledge about the CDSCO SUGAM portal
- Changing regulatory needs for medical devices
The guidance of regulatory experts can assist in avoiding these obstacles.
Benefits of CDSCO Certification for Dental Products
Obtaining CDSCO Certification for Dental Products is not just a compliance matter but also a valuable investment which would help build the credibility of your products, improve their acceptance and pave the way for future business growth. The issuance of the CDSCO certificate indicates that your dental products conform to Indian medical device regulations.
The following are some of the advantages of the CDSCO certification:
- Legal Right to Sell Products in India
- Credibility of Products
- Patient Safety
- Increased Market Potential
- Smoother Imports & Distribution
- Business Edge
- Regulatory Risks Reduced
- Business Growth
Common Mistakes to Avoid During CDSCO Certification
Many applications face delays due to avoidable mistakes made during the registration procedure. The following common mistakes should be avoided to save your time and efforts.
Don’t make the following mistakes:
- Wrong classification of the dental product
- Using an incorrect application form
- Incomplete documentation
- Missing or outdated test reports
- Device Master File (DMF) mistakes
- Incomplete Plant Master File (PMF)
- Failure to comply with the ISO 13485 guidelines
- Product labeling mistakes
- Not replying to the questions by CDSCO
- Submitting the application without professional regulatory review
Why Choose UMSPCS for CDSCO Certification for Dental Products?
It could be complicated for companies seeking CDSCO Certification for Dental Products, particularly for those that are seeking approval for the first time or are handling different product types.
UMSPCS has more than 6 years of experience and over 600 product compliances under its belt. With our help, manufacturers, importers, and healthcare firms in India get their CDSCO Certification fast, accurately, and without any trouble.
Services provided by us include:
- Classification of the product and its regulatory assessment
- Selection of the appropriate licensing authority and the relevant application forms
- Creation of Device Master File (DMF)
- Creation of Plant Master File (PMF)
- ISO 13485 documentation support
- Technical document creation and review
- Application filing through the CDSCO SUGAM Portal
- Liaisoning with CDSCO and State Licensing Authorities
- Query handling and regulatory support
- Audit and inspection assistance
- Post-licensing regulatory services
Why Choose UMSPCS for CDSCO Certification for Dental Products?
It could be complicated for companies seeking CDSCO Certification for Dental Products, particularly for those that are seeking approval for the first time or are handling different product types.
UMSPCS has more than 6 years of experience and over 600 product compliances under its belt. With our help, manufacturers, importers, and healthcare firms in India get their CDSCO Certification fast, accurately, and without any trouble.
Services provided by us include:
- Classification of the product and its regulatory assessment
- Selection of the appropriate licensing authority and the relevant application forms
- Creation of Device Master File (DMF)
- Creation of Plant Master File (PMF)
- ISO 13485 documentation support
- Technical document creation and review
- Application filing through the CDSCO SUGAM Portal
- Liaisoning with CDSCO and State Licensing Authorities
- Query handling and regulatory support
- Audit and inspection assistance
- Post-licensing regulatory services
Conclusion
With the continuous growth of the Indian dental healthcare industry, regulatory compliance has become mandatory for both manufacturers and importers. CDSCO Certification for Dental Products is a mandatory requirement for many dental devices and signifies that your products are certified with the needed standards of safety and quality performance under the Medical Devices Rules, 2017.
It consists of several processes including product classification, technical documentation, quality management compliance, regulatory review and, wherever needed, facility audits. Although the whole process might be complicated, it can be much easier with proper guidance.
In case you have plans to produce, import or market dental products in India, our team is always ready to assist you. We offer all-inclusive help from our qualified professionals to ensure that you get through the process without any problems and become compliant with CDSCO in time.
Need professional help with CDSCO Certification in India?
Just contact us for assistance with product classification, technical documentation, regulatory approvals and all-inclusive compliance services. With our specialists, you will obtain your CDSCO Certification for Dental Products quickly and easily. Also can get to know more information about CDSCO Cardiovascular Medical Device Registration.
Frequently Asked Questions (FAQs)
Yes, CDSCO or State Licensing Authority approval is compulsory for the manufacture, import, and distribution of most of the dental products notified under the Medical Devices Rules, 2017 in India.
Class A & B devices licenses are issued by the State Licensing Authorities whereas CDSCO regulates the Class C & D dental products.
Some of the critical documents are Device Master File (DMF), Plant Master File (PMF), ISO 13485 certificate, test report, labeling and company registration documents.
The CDSCO certification process will usually take about 6 to 12 months.
It depends upon device class, government fee, testing and documentation and consultancy.
Yes, foreign companies may register an AIR and get an import license on the CDSCO SUGAM portal.
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