CDSCO License for Bone Marrow Needle

Comprehensive Guide to CDSCO Licensing for Bone Marrow Needle (Class B Disposable Hypodermic Needle)

Bone marrow needles are critical disposable hypodermic devices used to collect samples directly from the bone marrow for diagnostic and therapeutic purposes. Given their invasive nature and direct patient contact, the CDSCO classifies bone marrow needles as Class B medical devices under the notification 29/Misc/3/2017-DC (292). Compliance with CDSCO regulations is mandatory for manufacturers or importers aiming to distribute these devices in the Indian market.

Having successfully assisted over 500 companies in navigating the CDSCO licensing landscape, we provide you with a thorough, step-by-step overview ensuring a smooth and timely approval process.

CDSCO Regulatory Framework for Bone Marrow Needle

The Central Drugs Standard Control Organisation (CDSCO) governs medical device regulation in India. Bone marrow needles fall under Class B, which means they pose a low to moderate risk to patients. The regulatory framework mandates obtaining a manufacturing license (MD5) from the respective State Licensing Authority before production and sale.

Risk Classification and License Requirements for Bone Marrow Needle

Device Name: Bone Marrow Needle
Risk Class: B (Low-Moderate Risk)
Category: Disposable Hypodermic Needles
Notification: 29/Misc/3/2017-DC (292), dated 06.06.2018

Class B devices require an MD5 license (manufacturing) as per Form MD3 application, which is issued by the State Licensing Authority.

Manufacturing License Process (MD5) for Bone Marrow Needle

The MD5 license process involves several key stages:

Test License (Form MD13): Before applying for MD5, you need a test license to legally test your device. This usually takes 1.5 to 2 months.
Product Testing: Conduct testing at CDSCO-recognized government-approved laboratories to validate conformity with essential principles.
Document Preparation: Assemble all required documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
Application Submission: File your MD5 application (Form MD3) via the CDSCO MD Online Portal.
Audit by Notified Body: An audit by a notified body listed on the CDSCO website is conducted to verify compliance.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant: Once all conditions are satisfied, the MD5 license is issued (Form MD5).

Typically, the entire process takes approximately 3 to 4 months.

Manufacturing License Documents Required for Bone Marrow Needle

To streamline your application, ensure you have the following documents ready:

Company Constitution (e.g., Incorporation Certificate, Partnership Deed)
Proof of Ownership or Lease of Manufacturing Premises
Details and Qualifications of Technical Staff
Fire Safety NOC
Pollution Control Board NOC
Device Master File (DMF): Detailed design, materials, and manufacturing process documentation. For guidance, see our comprehensive Device Master File guide.
Plant Master File (PMF): Manufacturing site information and quality controls. Learn more at our Plant Master File guide.
Essential Principles Checklist confirming compliance with Indian Medical Device Rules
Risk Management File documenting hazard identification and mitigation, aligned with ISO 14971 principles (see Risk Management)
Product Test Reports from CDSCO-approved laboratories (List of Testing Labs)
Product Labeling and Instructions for Use (IFU)
Quality Management System (QMS) documents, ideally ISO 13485 certified

Import License Process (MD15) for Bone Marrow Needle

For companies importing bone marrow needles, an import license (MD15) from the Central Licensing Authority is mandatory. While our focus here is manufacturing, it is important to note the import license process involves:

Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and Device/Plant Master Files
Application submission on the CDSCO MD Online Portal
Resolution of any departmental queries
License grant typically within 5-6 months

For detailed import license procedure, refer to our Import License guide.

Import License Documents Required

Valid Manufacturing License from the country of origin
Free Sale Certificate
ISO 13485:2016 Certificate
CE Certificate (if applicable)
Device Master File
Plant Master File
Wholesale License
Company Constitution Documents

Timeline and Processing Duration

Process Stage	Estimated Duration
Test License (MD13)	1.5 – 2 months
Product Testing	2 – 3 weeks
Document Preparation	2 – 4 weeks
Application & Audit Process	1 – 1.5 months
Query Resolution	2 – 3 weeks
Total Time for MD5 License	3 – 4 months

Planning ahead and preparing documents meticulously can help avoid delays.

Government Fees and Costs

Application Fee: ₹5,000 per application
Product Fee: ₹500 per product (Bone Marrow Needle counts as one product)
Test License Fees: Typically included in application process

Additional costs may include fees for notified body audits, product testing, and consultancy services.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Many manufacturers face delays due to limited capacity at government-approved testing labs.
Solution: Engage with testing labs early in the process and consider private or third-party labs recognized by CDSCO for faster turnaround.

Challenge 2: Incomplete Documentation

Missing or inconsistent documents are a major cause of application rejection or queries.
Solution: Use detailed checklists and consult experts to prepare Device Master File, Plant Master File, and Risk Management File thoroughly.

Challenge 3: Audit Non-Compliance

Audit by notified bodies can reveal gaps in QMS or production controls.
Solution: Conduct internal pre-audits and quality reviews before official audits.

Challenge 4: Query Resolution Delays

Slow responses to CDSCO queries prolong approval timelines.
Solution: Assign dedicated personnel to handle regulatory correspondences promptly.

Expert Consultation and Support

With over 25 years of experience and a track record of enabling 500+ companies to obtain CDSCO licenses, we offer:

Customized regulatory strategy for Bone Marrow Needle licensing
End-to-end assistance from test license to final audit
Documentation preparation and review services
Liaison with notified bodies and CDSCO officials
Training on post-market surveillance requirements

Reach out to us early in your product development cycle to avoid costly setbacks.

Getting Started with Your CDSCO License Application for Bone Marrow Needle

Assess Your Product Classification: Confirm your device falls under Class B as per CDSCO classification. You can verify your device class through our Medical Device Classification resource.
Register on CDSCO MD Online Portal: Submit your application and monitor progress via the official CDSCO MD Online Portal.
Apply for Test License (MD13): Prepare and submit your test license application to initiate product testing.
Plan Product Testing: Schedule testing with CDSCO-approved laboratories early to avoid bottlenecks.
Prepare Essential Documentation: Develop robust Device Master File, Plant Master File, and Risk Management File.
Engage a Notified Body: Identify and liaise with a notified body from the official Notified Bodies List for the audit.
Submit MD5 Application: Once test reports and documentation are ready, submit your MD5 application through the portal.
Prepare for Audit: Conduct internal audits and readiness assessments.
Respond to Queries Promptly: Keep communication lines open with CDSCO and notified body.

By following these actionable steps and leveraging expert support, manufacturers of bone marrow needles can confidently navigate the regulatory pathway to market entry in India.

For further details or personalized assistance, feel free to contact our regulatory consulting team.