CDSCO License for Gingival Bleaching Protector
Medical Device Information
Intended Use
A non-sterile paste or gel-like substance designed to protect a patients gums from the hydrogen peroxide (H2O2) found in teeth whitening agents used during chairside light-curing bleaching of the teeth.
Comprehensive Guide to CDSCO Licensing for Gingival Bleaching Protector (Class B Dental Device)
As specialists with over 25 years supporting 500+ clients through India's medical device regulatory landscape, we understand the nuances of obtaining CDSCO licenses for devices like the Gingival Bleaching Protector. This dental device, classified as Class B under the CDSCO framework, is a non-sterile paste or gel designed to shield gums from hydrogen peroxide during teeth whitening treatments. Given its intended use and risk profile, the regulatory pathway involves securing an MD5 Manufacturing License from the State Licensing Authority. Here, we walk you through the entire process with practical tips, timelines, and costs to ensure a smooth approval journey.
CDSCO Regulatory Framework for Gingival Bleaching Protector
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India. The Gingival Bleaching Protector falls under the dental device category with Notification 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022, officially recognizing its classification as Class B. This classification mandates adherence to specific regulatory controls to ensure safety and efficacy.
Risk Classification and License Requirements
- Risk Class: B (Low to Moderate Risk)
- License Type: MD5 Manufacturing License (Application Form MD3)
- Licensing Authority: State Licensing Authority
Class B devices like the Gingival Bleaching Protector require a stringent but streamlined approval process compared to higher risk devices. This includes laboratory testing, documentation compliance, and a notified body audit.
Manufacturing License Process (MD5)
The manufacturing license process for Class B devices is methodical and typically spans 3 to 4 months. The key steps include:
Test License Acquisition (Form MD13): Before full manufacturing license application, obtain a Test License to manufacture the device for testing purposes. This usually takes 1.5 to 2 months.
Product Testing: Conduct mandatory product testing at CDSCO-approved government laboratories. Testing ensures the device meets Indian standards for safety and performance. Refer to the list of testing laboratories for options.
Document Preparation: Compile and verify all required documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality management system (QMS) documents.
License Application Submission: Apply online via the CDSCO MD Online Portal using Form MD3.
Notified Body Audit: A notified body conducts a manufacturing site audit. You can check the list of notified bodies to select an accredited auditor.
Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
Grant of MD5 License: Upon satisfactory compliance, the State Licensing Authority issues the MD5 Manufacturing License.
Manufacturing License Documents Required
To avoid delays, prepare the following documents carefully:
- Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed technical dossier of the Gingival Bleaching Protector. Our comprehensive Device Master File guide can help.
- Plant Master File (PMF): Documentation of manufacturing processes and controls. Learn more at our Plant Master File guide.
- Essential Principles Checklist confirming compliance with Indian standards
- Risk Management File detailing hazard analysis and mitigation strategies. For insights, visit our Risk Management guide.
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions For Use (IFU)
- Quality Management System (QMS) Documents such as ISO 13485 certification
Import License Process (MD15) for Gingival Bleaching Protector
If you plan to import the Gingival Bleaching Protector rather than manufacture it domestically, an MD15 Import License from the Central Licensing Authority is required. This process usually takes 5 to 6 months and demands additional documentation such as:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- CE Certificate or equivalent
- ISO 13485:2016 certification
- Wholesale License
You can submit applications on the CDSCO MD Online Portal using Form MD14.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 2 to 3 weeks |
| License Application (MD5) | 1 month (incl. audit) |
| Query Resolution | 2 to 4 weeks |
| Total Time | 3 to 4 months |
Government Fees and Costs
- Application Fee: Rs. 5,000 per application
- Per Product Fee: Rs. 500 per product
These fees are payable online during application submission on the CDSCO portal. Additional costs include notified body audit fees and product testing charges, which vary depending on the auditor and lab.
Common Challenges and Solutions
Delayed Test Reports: Testing at government labs can sometimes face backlogs. To mitigate this, start test license application early and consider labs with shorter turnaround times.
Incomplete Documentation: Missing or improperly formatted files are a frequent cause of delays. Use our Device Master File and Plant Master File guides to ensure completeness.
Audit Non-Compliance: Prepare your manufacturing site rigorously by conducting internal audits prior to notified body visits.
Query Resolution Delays: Assign dedicated regulatory personnel to respond swiftly to CDSCO and notified body queries.
Expert Consultation and Support
Leveraging our 25+ years of expertise, we provide end-to-end support for obtaining MD5 licenses for Class B devices such as the Gingival Bleaching Protector. Our services include:
- Document preparation and review
- Coordination with notified bodies and testing labs
- Application submission and tracking on the CDSCO MD Online Portal
- Audit readiness assessments
- Post-approval compliance advice
Getting Started with Your CDSCO License Application
To begin your CDSCO licensing journey for the Gingival Bleaching Protector:
Evaluate Your Device Classification: Confirm Class B status using the Medical Device Classification resource.
Prepare Test License Application: Submit Form MD13 for the test license via CDSCO's online portal.
Coordinate Product Testing: Reach out to CDSCO-approved labs early to schedule testing.
Compile Comprehensive Documentation: Utilize our Device and Plant Master File guides to prepare robust dossiers.
Select a Notified Body: Choose an auditor from the notified bodies list and schedule the audit.
Submit MD5 Application: Once test license and testing are complete, apply using Form MD3.
Track Application and Address Queries: Stay proactive in communications with CDSCO to expedite approval.
By following these detailed steps, manufacturers and importers of the Gingival Bleaching Protector can navigate the CDSCO regulatory process efficiently and enter the Indian market confidently.
For personalized assistance, please contact us to leverage our proven regulatory expertise.
