CDSCO License for Dental cotton roll
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
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.
Comprehensive Guide to CDSCO Licensing for Dental Cotton Rolls (Class A Medical Device)
Dental cotton rolls are essential consumables in dental procedures, primarily used as absorbent, hard-packed cylinders to control saliva and improve operative exposure. Classified as a Class A medical device under the CDSCO framework, dental cotton rolls require specific regulatory compliance to be marketed and manufactured in India. With over 25 years of expertise and having supported 500+ companies in securing CDSCO licenses, we provide you with detailed, actionable insights to navigate this process efficiently.
Understanding the CDSCO Regulatory Framework for Dental Cotton Rolls
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, and dental cotton rolls fall under Class A (low risk) per the Medical Device Rules, 2017. The applicable notification for dental devices, including cotton rolls, is Notification 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022.
As a Class A device, the licensing and regulatory oversight are handled by the State Licensing Authority, making the process comparatively straightforward but still requiring strict adherence to documentation and quality standards.
Risk Classification and License Requirements for Dental Cotton Rolls
- Risk Class: A (Low Risk)
- License Type: MD5 Manufacturing License
- Authority: State Licensing Authority
- Application Form: MD3 for manufacturing license, MD13 for initial test license
Dental cotton rolls, being Class A, mandate an MD5 license, which includes obtaining a test license (MD13), product testing from CDSCO-approved labs, plant and device master file submissions, QMS compliance, and audit by a notified body.
Step-by-Step Manufacturing License Process (MD5) for Dental Cotton Rolls
- Obtain Test License (Form MD13): Before the manufacturing license application, companies must apply for a test license, which allows product testing. This process typically takes 1.5 to 2 months.
- Product Testing: Conduct mandatory testing at CDSCO-recognized laboratories to ensure compliance with standards. You can consult the list of testing laboratories for approved facilities.
- Document Preparation: Compile required documents including Device Master File, Plant Master File, Quality Management System (QMS) documents, and risk management files.
- Apply for Manufacturing License (Form MD3): Submit your application through the CDSCO MD Online Portal for the MD5 license.
- Audit by Notified Body: An audit will be conducted by a notified body to verify compliance. Refer to the list of notified bodies to select your auditor.
- Resolve Queries: Address any queries raised by the licensing authority or auditor promptly.
- Grant of License (Form MD5): Upon successful verification and audit, the State Licensing Authority will issue the MD5 license.
Essential Documents Required for MD5 License Application
- Company Constitution (e.g., Memorandum and Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing process. For guidance, see our detailed Device Master File guide.
- Plant Master File (PMF) outlining premises and manufacturing infrastructure. Learn how to prepare one in our Plant Master File guide.
- Essential Principles Checklist demonstrating compliance with Indian regulatory principles
- Risk Management File covering hazard identification and mitigation strategies. Our Risk Management guide can assist here.
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents, preferably ISO 13485:2016 certification or equivalent
Import License Process (MD15) for Dental Cotton Rolls
For importers, an MD15 license issued by the Central Licensing Authority is mandatory. The process includes:
- Document preparation (including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485, CE certificate where applicable)
- Application submission via the CDSCO MD Online Portal
- Query resolution
- License grant
Typical processing time is approximately 5-6 months. Detailed requirements and fees vary by device class.
Timeline and Processing Duration for MD5 License
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 2 to 3 weeks |
| MD5 Application & Audit | 1 to 1.5 months |
| Query Resolution | 2 to 4 weeks |
| Total Estimated Time | 3 to 4 months |
Government Fees and Cost Breakdown
| Fee Component | Cost (INR) |
|---|---|
| Application Fee | 5,000 |
| Per Product Fee | 500 |
| Test License Fee (MD13) | Included in above or minimal |
Note: Additional costs may include product testing fees at approved labs and audit fees charged by notified bodies.
Common Challenges and Practical Solutions
- Delayed Test Reports: Testing delays can stall your license; select labs with faster turnaround from the CDSCO Testing Laboratories list.
- Incomplete Documentation: Missing or inconsistent documents are a common cause of queries. Use comprehensive checklists like those in our Device and Plant Master File guides.
- Audit Non-Compliance: Prepare thoroughly for notified body audits by conducting internal audits and staff training.
- Query Resolution Delays: Respond promptly to regulatory queries with clear, evidence-backed documentation.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for first-time manufacturers or importers. Our consultancy, with a proven track record of assisting over 500 companies, offers:
- End-to-end application preparation
- Gap analysis and documentation support
- Coordination with notified bodies and testing labs
- Post-license compliance and renewal assistance
Getting Started with Your CDSCO License Application for Dental Cotton Rolls
- Assess your manufacturing setup: Ensure your facility meets the regulatory prerequisites and that you have qualified technical staff.
- Prepare key documents: Begin drafting your Device Master File and Plant Master File using our expert guides.
- Apply for Test License (MD13): Initiate the process online at the CDSCO MD Online Portal.
- Plan product testing: Select a CDSCO-approved testing laboratory early to avoid delays.
- Engage a Notified Body: Schedule your audit in advance by referring to the Notified Bodies list.
- Maintain transparent communication: Promptly address any queries from regulators or auditors.
Starting your licensing journey with these practical steps will streamline your path to market. Our team is ready to assist you at every stage to ensure timely approval and compliance.
For more detailed information on MD5 licensing, view our comprehensive MD5 License Guide.
Embark on your regulatory journey confidently with expert support tailored to dental cotton rolls – a critical component in dental care.
