CDSCO Dental Medical Device Licensing for Import & Classification

Dentistry in India is evolving rapidly, with sophisticated equipment and materials used for better patient care. However, the tools that make dental practices and procedures successful need to be reliable and up to the quality standards set by CDSCO. As the apex regulatory authority for medical devices in India, it has set certain requirements, which manufacturers or importers of dental medical devices must know. To make it easier for you, we’ve explained the major processes and requirements for CDSCO dental Medical devices and licensing in this post.

Table of Contents

Medical Devices Used in Dentistry

Dental medical devices are tools and instruments that dentists use daily to detect dental problems, treat them, and manage patient comfort. Examples are:

Dental mirrors for examination
Scalers for removing tartar
Probes for detecting cavities
Headlights for visibility
Cements for tooth restoration
Specialized dental devices are prosthetic devices like crowns and dentures, orthodontic appliances, and surgical kits

If a device is poorly made, like a dental mirror, it may scratch a patient’s tooth during examination. In the same way, a faulty suction system could allow fluid aspiration during procedures. That’s why CDSCO regulates dental devices strictly, as patient safety depends on it.

How CDSCO Regulates Dental Medical Devices?

CDSCO regulates dental medical devices under the Medical Devices Rules, 2017. Accordingly, they have published a comprehensive list of dental medical devices. This official notification classified dental devices into risk categories.

This classification had many positive outcomes. Previously, many dental devices operated without clear regulatory pathways, but this notification brought structure and clarity to the process. Manufacturers started knowing exactly which devices required licensing and which regulatory pathway applied.

Today, it keeps a detailed oversight of dental device manufacturing, import, sale, and distribution. Every dental device manufacturer or importer must obtain a proper CDSCO dental device license before setting themselves up for success in the Indian market. Otherwise, they are subject to penalties, fines, and business shutdown.

CDSCO Dental Device Classification:

CDSCO divides dental devices into four risk categories. These are Class A, Class B, Class C, and Class D. Your device’s classification determines which licensing pathway applies and what documentation you must submit. Note that since Class C and Class D dental devices have the potential to pose greater harm to patients if unreliable, they require more stringent regulatory processes.

Class A dental devices, like Dappen dish, Dental excavator, Dental Collar/ Crown scissors, and more, come in the lowest risk category. They carry minimal potential for patient harm if they fail to function as intended.
Class B devices present a moderate risk compared to Class A. Some examples are Dental crown/bridge, Dental bone particle collector, and Dental suction system.
Class C and Class D dental devices require CDSCO approval and are not regulated by the State Licensing authority. These devices carry moderate to high risk. A few examples are Bone matrix implant, Temporary mandibular condyle prosthesis, Dental surgical procedure kit, and more.

Updated Risk-Based Classification of Dental Medical Devices by CDSCO

To determine the risk class of your dental device, refer to the table below:

S No.	Medical Device Name	Risk Class
1	Dental impression material	A
2	Dental collar/crown scissors	A
3	Dental excavator, reusable	A
4	Dental excavator, single-use	A
5	Dappen dish, reusable	A
6	Dappen dish, single-use	A
7	Dental examination kit	A
8	Dental crown, polymer	B
9	Dental crown/bridge resin, temporary	B
10	Dental crown/bridge, temporary	B
11	Dental material mixing surface, reusable	A
12	Dental material mixing surface, single-use	A
13	Dental spatula, reusable	A
14	Dental spatula, single- use	A
15	Dental crown, metal/ceramic	B
16	Dental crown, metal/polymer	B
17	Dental impression material kit, reusable	A
18	Dental impression material kit, single-use	A
19	Dental impression material mixer	A
20	Dental impression material syringe	A
21	Dental impression tray material	A
22	Dental impression tray, reusable	A
23	Dental polishing brush	A
24	Dental bone particle collector	B
25	Dental bone matrix implant, animal-derived	C
26	Dental suction system	B
27	Dental suction system cannula, reusable	A
28	Dental suction system cannula, single-use	A
29	Carboxymethylcellulose sodium denture adhesive	B
30	Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free	B
31	Dental amalgam	B
32	Dental suction system fluid-separation unit	A
33	Dental suction system pump	B
34	Temporary mandibular condyle prosthesis	C
35	Temporomandibular joint disc	C
36	Bar dental precision attachment	A
37	Dental suction system disinfection control unit	B
38	Transgingival implant	C
39	Zinc polycarboxylate dental cement	B
40	Transmandibular implant	C
41	Pliable-polymer dental regeneration membrane, bioabsorbable, ligated	C
42	Pliable-polymer dental regeneration membrane, bioabsorbable, tacked	C
43	Dental surgical procedure kit, medicated, reusable	C
44	Dental surgical procedure kit, medicated, single-use	C
45	Membrane fixation tack, bioabsorbable	C
46	Periodontal root surface regeneration material	C
47	Periodontal tissue reconstructive material	C
48	Bone matrix implant, human-derived	C
49	Collagen dental regeneration membrane	C
50	Dental cotton roll	A
51	Dental impression tray, single-use	A
52	Preformed dental crown, permanent	B
53	Preformed dental crown, temporary	B
54	Zinc phosphate dental cement	B
55	Dental articulation paper forceps	A
56	Dental dressing forceps, reusable	A
57	Dental dressing forceps, single-use	A
58	Rubber dam clamp forceps	A
59	Tooth extraction forceps	A
60	Dental amalgam mercury dispenser	A
61	Dental anesthesia injection kit	B
62	Dental anaesthesia syringe cartridge	C
63	Dental anaesthesia syringe, intraligamentary	C
64	Dental anaesthesia syringe, reusable	B
65	Dental anaesthesia syringe, single-use	B
66	Dental anaesthesia syringe/needle	B
67	Dental anaesthesia system	C
68	Bite registration rim	B
69	Bite registration rim wax	A
70	Bite registration rim wax, plate	B
71	Calcium hydroxide dental cement	B
72	Ceramic artificial teeth	B
73	Dental soft-tissue matrix implant, animal-derived	C
74	Dental Bonding Agents	B
75	Dental Etchant	B
76	Dental Prosthesis Priming Agent	B
77	Restorative Material	B
78	Orthodontic Adhesive	B
79	Dental Varnishes/ Glazing	B
80	Dental Cements	B
81	Dental Root Surface Conditioner	B
82	Dental Cleansing Solution	B
83	Endodontic Sealer	B
84	Oral Cavity Abrasive Polishing Agent	A
85	Root Canal Filling Removal Solution	B
86	Dental Composite Resin Kit	B
87	Gingival Bleaching Protector	B
88	Dental Caries Removal Solution	B
89	Denture Base Resin	B
90	Polymer-Based Prosthodontic Material	B
91	Powered Surgical Drill Handpiece for Dental Applications	B
92	Orthodontic appliance, Band	B
93	Orthodontic Elastomeric	A
94	Orthopaedic dental file	B
95	Dental endodontic enlarger	B

Types of CDSCO Licenses for Dental Products in India

Class A and B dental devices follow the MD-5/MD-6 manufacturing licensing process through state licensing authorities. Class C and Class D dental devices follow the MD-9/MD-10 licensing process. If you are an importer, you need the MD-15 import license.

Application Requirements for the Manufacturing License

Your application to manufacture dental Medical devices needs the following documents:

Device master file with extensive Device Details
Plant/Site Master File (PMF/SMF) describing the manufacturing facility, layout, processes, and controls
Quality management procedures
ISO 13485 certification or equivalent quality management documentation
Product test reports from approved laboratories
Post-market surveillance and adverse event reporting plan
Proof of facility ownership or lease
Building layout with room dimensions
Technical staff qualifications
Government Fees as per the Medical Devices Rules 2017

Safety/clinical safety summary, where applicable

How to Get the Form MD-15 License to Import Dental Devices in India?

CDSCO issues Form MD-15 license for all imported medical and dental devices. Regardless of your product’s risk class, you must follow the regulatory process for MD15 in order to gain approval. If the following documents are accurate and are submitted on time, you receive the license in stipulated time.

Application in Form MD-14
Regulatory approvals from the country of origin
Free Sale Certificate proving the device is freely sold in the country of origin
Free Sale Certificate from any of the following countries like United States of America (USA), United Kingdom (U.K), the European Union, Canada, Australia or Japan.
Device master file with complete technical specifications
Plant Master File as per the Medical Devices Rules 2017
Quality management system certification (ISO 13485 or equivalent)
Risk management documentation
Post-market surveillance Data
Audit Report

How to Navigate the Medical Device SUGAM Portal for Registering Dental Devices?

CDSCO launched this online portal to each regulatory submission. Through this portal, you submit applications electronically, track status, and respond to regulatory queries. When approval is given, you can download the license/certificates.

Use this portal in the following way to get approval:

Gather the documents needed for the registration process.
Open the CDSCO website and sign up on the Medical Device SUGAM portal.
Choose the purpose of your registration.
Fill out the required fields in the registration form
Upload the documents you gathered and create a strong password
After completing all form fields and uploading documents, click the Submit button to receive the confirmation email.
Confirm your email by tapping the verification link sent to it.

Concluding Words:

CDSCO dental medical devices regulation ensures patient safety in the growing dental sector. The extensive classification of devices demonstrates CDSCO’s commitment to dental care quality. You must understand it and follow the correct licensing pathway for market success.

If you feel confused or are getting into India’s medical device market for the first time, feel free to seek our help. As a top regulatory service provider with more than two decades of experience, we specialize in CDSCO medical device licensing for dental devices, surgical instruments, rehabilitation equipment, specialized medical technology, and many more. We serve manufacturers and importers across the globe with strategic regulatory guidance. Our Dueran consultant experts have been transforming licensing requirements into competitive business advantages for many years and are happy to assist you any day.

Frequently Asked Questions (FAQ’s)

1. What are the medical devices used in dentistry?

Medical devices used in dentistry are examination tools, like mirrors, probes, scalers, restoration materials, like cements, composites, and amalgam, and prosthetic devices, such as crowns or bridges.

2. How many types of dental instruments are there?

CDSCO classifies various dental medical devices into risk-based classes A, B, C and D for ease of the licensing process.

CDSCO Dental Medical Device Licensing for Manufacturing & Import