CDSCO License for Dental anaesthesia system
Medical Device Information
Intended Use
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.
Comprehensive Guide to CDSCO Licensing for Dental Anaesthesia Systems (Class C Medical Device)
Navigating the regulatory landscape for medical devices in India can be challenging, especially for specialized equipment such as the Dental Anaesthesia System. This device, designed to administer a controlled mix of oxygen and nitrous oxide during dental surgeries, falls under Class C risk category as per the CDSCO classification. With over 25 years of regulatory consultancy experience and having supported 500+ companies in securing CDSCO licenses, we offer a detailed, practical roadmap to help manufacturers and importers obtain the necessary approvals efficiently.
CDSCO Regulatory Framework for Dental Anaesthesia Systems
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules, 2017 (MDR 2017), which align with the global risk-based approach. The Dental Anaesthesia System is notified under Notification 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022, categorizing it as a Class C device due to its moderate to high risk profile.
Class C devices typically require stringent regulatory control as they directly impact patient safety during surgical interventions. The CDSCO framework mandates manufacturers or importers to obtain a manufacturing license (MD9) or import license (MD15) respectively before market entry.
Risk Classification and License Requirements for Dental Anaesthesia System
- Device Name: Dental Anaesthesia System
- Risk Class: Class C
- Intended Use: Administration of proportional mixtures of O2 and N2O or medical air during dental surgeries
- Regulatory Category: Dental Medical Device
As a Class C device, the Dental Anaesthesia System requires an MD9 manufacturing license issued by the Central Licensing Authority (CLA) of CDSCO. Importers must apply for an MD15 import license.
Manufacturing License Process (MD9) for Class C Devices
Obtaining the MD9 license is a multi-step process that typically takes 4 to 5 months, encompassing the following stages:
Test License Application (Form MD13): Initially, manufacturers must apply for a test license to produce samples for testing. This takes approximately 1.5 to 2 months to obtain.
Product Testing: Samples must be tested in CDSCO-approved government or notified laboratories to verify compliance with Indian standards. A list of approved testing laboratories is available on the CDSCO portal.
Document Preparation: Comprehensive technical documentation, including Device Master File and Plant Master File, is prepared. This documentation demonstrates compliance with Essential Principles and risk management requirements.
License Application (Form MD7): Submit the MD9 application with all supporting documents through the CDSCO MD Online Portal.
Inspection & Audit: CDSCO inspectors conduct a detailed audit of manufacturing premises, quality systems, and documentation.
Query Resolution: Address any observations or queries raised by CDSCO during the audit.
Grant of License: Upon satisfactory review and audit, the MD9 license is granted.
For an in-depth understanding, consult our MD9 License Guide.
Manufacturing License Documents Required
The MD9 application demands rigorous documentation, including but not limited to:
- Company Constitution (Incorporation Certificate, PAN card, GST registration)
- Proof of Ownership or Lease Agreement of manufacturing premises
- Details and qualifications of technical staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed description of the Dental Anaesthesia System’s design, components, specifications, and manufacturing processes. Learn how to prepare a DMF in our Device Master File Guide.
- Plant Master File (PMF): Documentation covering infrastructure, equipment, quality control procedures, and compliance measures. Refer to our Plant Master File Guide.
- Essential Principles Compliance Checklist
- Risk Management File demonstrating compliance with ISO 14971 standards. Practical tips on Risk Management are invaluable.
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Dental Anaesthesia Systems
For importers, the MD15 license is mandatory prior to marketing the Dental Anaesthesia System in India. The process generally spans 5 to 6 months and involves:
Preparing all requisite documents, including the manufacturing license from the country of origin, Free Sale Certificates, and quality certifications.
Applying on the CDSCO MD Online Portal using Form MD14.
Addressing any queries raised during the technical review.
Receiving the import license (Form MD15) upon approval.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Quality Management System certificate
- CE Certificate or equivalent international approval
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution
- Proof of authorized importer in India
Our Import License Guide offers comprehensive insights.
Timeline and Processing Duration
| License Type | Processing Time | Key Milestones |
|---|---|---|
| MD9 (Manufacturing) | 4-5 months | Test license (1.5-2 months) → Testing → Application → Audit → License grant |
| MD15 (Import) | 5-6 months | Document prep → Application → Review → License grant |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 | ₹50,000 | ₹1,000 |
| MD15 (Class C) | $3,000/site (approx ₹2.5 lakh) | $1,500/product (approx ₹1.25 lakh) |
Note: Fees are subject to currency fluctuations and CDSCO updates.
Common Challenges and Solutions
Challenge 1: Delays in Testing
- Solution: Engage early with CDSCO-approved labs to schedule tests promptly. Maintain a buffer in project timelines.
Challenge 2: Incomplete Documentation
- Solution: Follow comprehensive checklists and use expert consultation services. Our experience shows that missing Device or Plant Master Files often cause rejections.
Challenge 3: Audit Non-compliance
- Solution: Perform internal audits and gap analyses before CDSCO inspection. Make sure QMS and risk management files are up-to-date.
Challenge 4: Query Resolution Delays
- Solution: Assign dedicated regulatory personnel or consultants to respond quickly and thoroughly.
Expert Consultation and Support
Our seasoned regulatory team offers tailored support from document preparation, audit readiness, to query management, ensuring smooth CDSCO licensing for Dental Anaesthesia Systems. We've helped over 500 companies navigate these complexities with proven success.
Getting Started with Your CDSCO License Application
Assess your Device Classification: Confirm your Dental Anaesthesia System is Class C under the latest CDSCO notification.
Initiate Test License Application: Apply for MD13 to begin sample production for testing.
Plan Testing Logistics: Engage with notified testing labs early. Refer to the Testing Laboratories list.
Prepare Device and Plant Master Files: Utilize our guides to ensure thorough documentation.
Register on the CDSCO MD Online Portal: Submit applications electronically for transparency and tracking.
Schedule Pre-audit Assessments: Conduct mock audits to identify gaps.
Engage with Notified Bodies: For audit requirements, refer to the Notified Bodies List.
By following these actionable steps and leveraging expert guidance, manufacturers and importers can efficiently secure their CDSCO licenses, ensuring timely and compliant market entry for Dental Anaesthesia Systems in India.
For personalized assistance, reach out to our regulatory consultants who specialize in medical device compliance and licensing.
Embark on your CDSCO licensing journey today with confidence and expert support.
