CDSCO License for Single Lumen Hypodermic Needle
Medical Device Information
Intended Use
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Introduction to Single Lumen Hypodermic Needle and Regulatory Importance
A Single Lumen Hypodermic Needle is an essential medical device designed for injecting fluids into or withdrawing fluids from body parts beneath the skin surface. Classified under disposable hypodermic needles, this device plays a critical role in healthcare delivery, demanding stringent regulatory compliance to ensure safety, efficacy, and quality.
Given its classification as a Class B medical device under the CDSCO framework, obtaining the appropriate manufacturing or import license is mandatory before marketing in India. Compliance with CDSCO regulations not only safeguards patient safety but also ensures smooth market access and brand credibility.
With over 25 years of experience assisting 500+ companies in navigating CDSCO licensing, we understand the nuances and practical challenges manufacturers and importers face. This comprehensive guide focuses on the regulatory pathway for the Single Lumen Hypodermic Needle, providing actionable insights on timelines, costs, document preparation, and common hurdles.
CDSCO Regulatory Framework for Single Lumen Hypodermic Needle
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Devices Rules, 2017. According to Notification No. 29/Misc/3/2017-DC (292) dated 06.06.2018, Single Lumen Hypodermic Needles fall under Class B – a low to moderate risk category.
Class B devices require a manufacturing license from the State Licensing Authority via the MD5 license process. Importers need to apply for the MD15 import license through the Central Licensing Authority.
The regulatory framework mandates compliance with Good Manufacturing Practices (GMP), product testing by government-approved laboratories, and submission of comprehensive technical documentation.
Risk Classification and License Requirements for Single Lumen Hypodermic Needle
The Single Lumen Hypodermic Needle is classified as Class B due to its moderate risk profile as a disposable invasive device. This classification defines the licensing route:
- Manufacturing License: MD5 license (Form MD3) granted by the State Licensing Authority.
- Import License: MD15 license (Form MD14) granted by the Central Licensing Authority.
Class B devices require a test license (MD13) prior to manufacturing license application, ensuring product testing compliance.
For detailed classification, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Single Lumen Hypodermic Needle
The MD5 manufacturing license application for Class B devices involves several key stages:
Test License Application (Form MD13): Obtain a test license for initial production and testing. This stage takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory product tests at CDSCO-approved laboratories to verify compliance with essential principles.
Documentation Preparation: Compile the complete dossier including Device Master File, Plant Master File, risk management, and quality system documents.
Application Submission (Form MD3): Apply online through the CDSCO MD Online Portal.
Audit by Notified Body: An audit of manufacturing premises and quality systems by a CDSCO-notified body is mandatory. Check the list of notified bodies to select an auditor.
Query Resolution: Address any observations or queries raised by the licensing authority or the notified body.
Grant of License (Form MD5): Upon satisfactory compliance, the State Licensing Authority issues the manufacturing license.
The entire process typically spans 3 to 4 months from test license application to license grant.
For an in-depth overview, refer to our MD5 License Guide.
Manufacturing License Documents Required for Single Lumen Hypodermic Needle
Manufacturers must prepare a comprehensive set of documents including:
- Company Constitution/Registration Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed device design and manufacturing process information. Learn more from our Device Master File guide.
- Plant Master File (PMF): Documentation of manufacturing facilities and quality systems. See our Plant Master File guide.
- Essential Principles Checklist confirming compliance with regulatory standards
- Risk Management File demonstrating hazard analysis and mitigation strategies. Our Risk Management resource can help.
- Test Reports from CDSCO-approved laboratories
- Product Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified
Ensuring accuracy and completeness of these documents significantly reduces the risk of delays.
Import License Process (MD15) for Single Lumen Hypodermic Needle
Importers seeking to bring Single Lumen Hypodermic Needles into India must apply for an MD15 import license:
Document Preparation: Assemble necessary certificates including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files.
Application Submission: File the application using Form MD14 via the CDSCO MD Online Portal.
Review and Queries: The Central Licensing Authority reviews the application and may raise queries.
Grant of Import License: Subject to compliance and satisfactory documentation, the import license is granted within 5 to 6 months.
Unlike manufacturing, no test license is required for import applications.
For more details, see our Import License Guide.
Import License Documents Required for Single Lumen Hypodermic Needle
Key documents for MD15 license application include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate or Certificate of Market Authorization
- ISO 13485:2016 Certification
- CE Certificate or Equivalent
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution
Completing this documentation upfront prevents unnecessary delays during review.
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Manufacturing License (MD5) | 3 to 4 months (including test license and audit) |
| Import License (MD15) | 5 to 6 months |
Planning your product launch timeline accordingly is crucial to avoid market entry delays.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 License | Rs 5,000 | Rs 500 |
Additional costs include testing fees at approved labs and notified body audit fees, which vary based on scope.
Budgeting for document preparation, testing, and consultancy services is equally important.
Common Challenges and Solutions
Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. Solution: Use checklists and consult experts to ensure completeness.
Testing Delays: Limited slots at government-approved labs can extend timelines. Solution: Schedule tests early and consider multiple approved labs from the Testing Laboratories list.
Audit Non-Compliance: Non-conformities during notified body audits can stall approval. Solution: Conduct pre-audit internal assessments and training.
Query Management: Delayed or inadequate response to regulatory queries prolongs processing. Solution: Respond promptly with precise, well-documented answers.
Expert Consultation and Support
Navigating CDSCO licensing for Single Lumen Hypodermic Needles requires expertise in regulatory requirements, document preparation, and process management. Our seasoned consultants have empowered over 500 manufacturers and importers to achieve timely approvals.
We offer tailored support including:
- Gap analysis of existing documentation
- Coordination with notified bodies and testing labs
- Application drafting and submission via the CDSCO MD Online Portal
- Regulatory strategy and compliance training
Engage with us early to streamline your path to market and mitigate risks.
Getting Started with Your CDSCO License Application
Assess Your Device Class: Confirm your device’s risk classification as Class B.
Prepare Required Documents: Gather company registration, premises proofs, and technical files including Device and Plant Master Files.
Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal.
Schedule Product Testing: Coordinate with CDSCO-approved labs to conduct necessary product tests.
Compile License Application: After test results, prepare the MD5 license application (Form MD3) with complete documentation.
Engage a Notified Body: Select an audit agency from the Notified Bodies list and schedule your audit.
Submit Application and Follow Up: File your application online and actively respond to any queries.
Taking these proactive steps will position your Single Lumen Hypodermic Needle product for a successful CDSCO licensing journey, enabling timely access to the Indian healthcare market.
For specialized assistance, contact our regulatory experts to ensure a smooth and compliant licensing process.
