CDSCO License for Blood Collecting Needle

Comprehensive Guide to CDSCO Licensing for Blood Collecting Needle (Class B Medical Device)

Manufacturers and importers of medical devices face a rigorous regulatory landscape in India, especially when it comes to obtaining necessary licenses from the Central Drugs Standard Control Organization (CDSCO). As a device category, Blood Collecting Needles fall under Class B risk classification and are regulated stringently to ensure patient safety and product quality. With over 25 years of experience helping 500+ companies successfully navigate CDSCO licensing, we provide you with an in-depth, practical guide tailored specifically for Blood Collecting Needles.

About Blood Collecting Needle and Its Regulatory Importance

A Blood Collecting Needle is designed for use with evacuated blood collection tubes to collect venous blood. Classified as Disposable Hypodermic Needles, these devices are critical in clinical settings, demanding compliance with safety and quality standards. The CDSCO notification number 29/Misc/3/2017-DC (292), dated 06.06.2018, governs this category, mandating manufacturers and importers to secure appropriate licenses before marketing in India.

CDSCO Regulatory Framework for Blood Collecting Needle

Blood Collecting Needles are categorized as Class B medical devices according to the CDSCO classification system. Class B devices are considered low to moderate risk and require a manufacturing license under the MD5 license scheme governed by the State Licensing Authority. Importers must obtain an MD15 import license from the Central Licensing Authority.

This framework ensures that devices meet essential principles related to safety, performance, and quality before entering the Indian market.

Risk Classification and License Requirements

• MD5 License: For manufacturing Class A and B devices, issued by the State Licensing Authority.
• MD15 License: For imported devices, issued by the Central Licensing Authority.

Manufacturing License Process for Blood Collecting Needle (MD5 License)

The MD5 license process for Class B devices involves multiple steps:

1. Test License Application (Form MD13): Obtain a test license allowing product testing.
2. Product Testing: Conduct necessary tests at CDSCO-approved laboratories.
3. Document Preparation: Compile technical and quality documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and others.
4. Application Submission (Form MD3): Apply for the manufacturing license via the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body for process and facility audit. Refer to the list of notified bodies.
6. Query Resolution: Address any observations or queries posed by the licensing authority or notified body.
7. Grant of License (Form MD5): Receive the manufacturing license upon satisfactory compliance.

Manufacturing License Documents Required

For Blood Collecting Needles, ensure you have the following documents ready for submission:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification of Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF) – detailing design, specifications, and manufacturing process (learn more about DMFs)
• Plant Master File (PMF) – describing manufacturing facilities and quality systems (PMF guide)
• Essential Principles Compliance Checklist
• Risk Management File specific to the device (risk management insights)
• Test Reports from CDSCO-approved laboratories (testing labs list)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents – ISO 13485:2016 certification is highly recommended

Import License Process for Blood Collecting Needle (MD15 License)

For importers, the process is centralized and slightly different:

1. Document Compilation: Prepare comprehensive technical and regulatory documents.
2. Application Submission (Form MD14): Submit the import license application via the CDSCO MD Online Portal.
3. Query Resolution: Respond to any clarifications sought by CDSCO.
4. Grant of License (Form MD15): License issued by the Central Licensing Authority.

Import License Documents Required

• Valid Manufacturing License issued by the country of origin
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate (for devices approved in Europe)
• Device Master File (DMF)
• Plant Master File (PMF)
• Wholesale Drug License (if applicable)
• Company Constitution and Incorporation Certificates

Timeline and Processing Duration

Government Fees and Costs

• MD5 License (Manufacturing Class B Devices):

  • Application fee: ₹5,000
  • Additional fee per product: ₹500

• MD15 License (Import Class B Devices):

  • Site fee: $2,000 (approx. ₹1,50,000)
  • Product fee per device: $1,000 (approx. ₹75,000)

Note: Fees are subject to change; always verify current rates on the CDSCO MD Online Portal.

Common Challenges and Solutions

• Delayed Testing Results: Testing at government-approved labs can take time. Plan ahead and submit your samples early.
• Incomplete Documentation: Missing or improperly prepared documents lead to delays. Use checklists and expert reviews.
• Audit Non-Compliance: Notified body audits can uncover gaps in QMS or facility standards. Conduct internal audits to preempt issues.
• Query Resolution Delays: Promptly respond to CDSCO queries with complete information to avoid processing stalls.

Expert Consultation and Support

Navigating CDSCO regulations for Blood Collecting Needles requires meticulous preparation and understanding of the regulatory framework. Our team has guided over 500 companies through this process, ensuring compliance and timely approvals. We assist with document preparation, audit readiness, liaising with notified bodies, and addressing CDSCO queries efficiently.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device falls under Class B using resources like our Medical Device Classification guide.
2. Prepare Technical Documentation: Develop your DMF, PMF, Risk Management File, and QMS documents.
3. Engage a CDSCO-Approved Testing Laboratory: Schedule product testing early.
4. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
5. Plan Internal Audits: Ensure your manufacturing site meets notified body requirements.
6. Submit Manufacturing License Application (Form MD3): Once testing and documentation are complete.

By following these focused steps and leveraging expert support, you can significantly streamline your path to obtaining the CDSCO manufacturing license for your Blood Collecting Needle. Reach out to our regulatory consultants today to start your application process with confidence.