CDSCO License for Dental needles
Medical Device Information
Intended Use
Dental needles are used to deliver local anaesthetic to the operative site in order to make a patient as comfortable as possible.
Comprehensive Guide to CDSCO Licensing for Dental Needles (Class B Medical Device)
Dental needles, classified as Class B medical devices under the CDSCO framework, are essential disposable hypodermic needles used to deliver local anaesthetic during dental procedures. Ensuring regulatory compliance for dental needles is crucial to guarantee patient safety, product quality, and smooth market entry in India. With over 25 years of expertise and having assisted 500+ companies, we provide an actionable roadmap to secure your CDSCO license efficiently.
CDSCO Regulatory Framework for Dental Needles
The Central Drugs Standard Control Organisation (CDSCO) governs the import, manufacturing, and sale of medical devices in India. Dental needles fall under the “Disposable Hypodermic Needles” category, notified vide Notification No. 29/Misc/3/2017-DC (18) dated 16.08.2018. As a Class B medical device, dental needles require a manufacturing license (MD5) from the State Licensing Authority or an import license (MD15) if imported.
Risk Classification and License Requirements for Dental Needles
- Device Name: Dental Needles
- Risk Class: B (Low moderate risk)
- License Type: MD5 (Manufacturing License) for domestic manufacturers; MD15 for importers
Class B devices are considered low to moderate risk, requiring adherence to essential principles of safety and performance, supported by comprehensive documentation, testing, and audit.
Manufacturing License Process for Dental Needles (MD5)
Manufacturers must follow a stepwise process to secure an MD5 license:
- Apply for Test License (Form MD13): This preliminary step allows product testing in government-approved laboratories. Expect 1.5 to 2 months for approval.
- Product Testing: Submit dental needle samples to CDSCO-recognized testing labs listed here. Testing ensures compliance with Indian standards.
- Document Preparation: Compile mandatory documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documentation.
- Apply for Manufacturing License (Form MD3): Submit completed application through the CDSCO MD Online Portal.
- Audit by Notified Body: A mandatory audit by a notified body from the official list of notified bodies to verify compliance.
- Queries Resolution: Address any queries from CDSCO or the notified body promptly.
- License Grant (Form MD5): Upon successful audit and document verification, the license is issued.
Manufacturing License Documents Required for Dental Needles
- Company Constitution (e.g., incorporation certificate)
- Proof of ownership or lease of manufacturing premises
- Technical staff qualifications and experience
- Fire NOC and Pollution Control Board NOC
- Device Master File
- Plant Master File
- Essential Principles Checklist
- Risk Management File adhering to ISO 14971 principles
- Test Reports from approved laboratories
- Product labels and Instructions For Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 certification
Import License Process for Dental Needles (MD15)
Importers of dental needles must secure an MD15 license from the Central Licensing Authority:
- Document Preparation: Gather manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate (if applicable), Device Master File, Plant Master File, wholesale license, and company constitution.
- Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
- Review and Queries: CDSCO reviews the submission and may raise queries.
- License Grant: Upon satisfactory resolution, the import license (Form MD15) is granted.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale Drug License
- Company Constitution
Timeline and Processing Duration
| License Type | Process Step | Duration |
|---|---|---|
| Test License (MD13) | Application to approval | 1.5 - 2 months |
| Product Testing | Sample submission to report | 1 - 1.5 months |
| MD5 License Application | Submission to audit | 1 month |
| Audit and Queries | Audit + resolution | 1 - 1.5 months |
| Total MD5 License Time | 3 - 4 months approx. | |
| MD15 Import License | Application to grant | 5 - 6 months |
Government Fees and Costs
- MD5 License:
- Application Fee: ₹5,000
- Per Product Fee: ₹500
- MD15 Import License:
- Class B Device: ₹2,000 per site
- ₹1,000 per product
Additional costs include laboratory testing fees and notified body audit charges, which vary depending on the notified body selected.
Common Challenges and Practical Solutions
Challenge 1: Delays in Test License Approval
- Solution: Submit a complete application with all technical files and ensure compliance with CDSCO formats to avoid back-and-forth queries.
Challenge 2: Product Testing Failures
- Solution: Conduct in-house pre-testing and quality checks before submitting samples to government labs.
Challenge 3: Audit Non-Compliance
- Solution: Engage experienced consultants to prepare audit-ready documentation and conduct mock audits.
Challenge 4: Documentation Gaps
- Solution: Use our comprehensive Device Master File guide and Plant Master File guide to ensure completeness.
Expert Consultation and Support
With over 500 successful CDSCO license applications under our belt, we specialize in guiding manufacturers of dental needles through every step—from initial application to final license issuance. Our team helps streamline documentation, coordinate with notified bodies, and ensure timely responses to CDSCO queries, drastically improving approval timelines.
Getting Started with Your CDSCO License Application for Dental Needles
- Assess Your Product Classification: Confirm your device risk class as B and understand applicable regulatory requirements via our Medical Device Classification resource.
- Initiate Test License Application: Prepare and submit Form MD13 on the CDSCO MD Online Portal.
- Engage Testing Laboratories Early: Contact government-approved labs immediately after test license approval to schedule timely testing.
- Start Document Compilation: Begin preparing your Device Master File, Plant Master File, Risk Management File, and QMS documents in parallel.
- Plan for Audit: Identify and coordinate with a notified body listed here to schedule your audit post testing.
- Consult with Experts: Leverage our regulatory consulting services to avoid common pitfalls and expedite license grant.
Embarking on CDSCO licensing for dental needles can be complex, but with structured planning, detailed documentation, and expert guidance, you can secure your MD5 manufacturing license within 3-4 months and confidently enter the Indian market. Contact us today to initiate your application and ensure compliance with India's stringent medical device regulations.
