CDSCO License for Bone grafting material

Comprehensive Guide to CDSCO Licensing for Bone Grafting Material (Class C Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and more than 500 successful CDSCO licensing projects, we understand the complexities manufacturers and importers face when bringing advanced medical devices like Bone Grafting Material into the Indian market. This internal prosthetic replacement device, classified as Class C under the CDSCO framework, requires meticulous preparation and adherence to stringent regulatory requirements. In this guide, we provide detailed, actionable insights on navigating the CDSCO licensing process, ensuring you are well-prepared for every step.

Understanding Bone Grafting Material and Regulatory Importance

Bone grafting materials are critical for reconstructing periodontal and bony defects in the oral and maxillofacial regions. Given their direct interaction with bone tissues and potential impact on patient safety, these devices fall under Class C by CDSCO, indicating a moderate-to-high risk profile that demands thorough regulatory scrutiny.

Obtaining the correct CDSCO license is not just a legal formality but a prerequisite for market access, patient safety assurance, and building trust among healthcare providers and patients.

CDSCO Regulatory Framework for Bone Grafting Material

The Central Drugs Standard Control Organisation (CDSCO) regulates all medical devices in India through defined classifications and licensing pathways. For Class C devices like bone grafting materials, the license is issued by the Central Licensing Authority under the MD9 license category, following the guidelines notified under 29/Misc/3/2017-DC (292) dated 06.06.2018.

Manufacturers and importers must comply with the Medical Device Rules, 2017, and submit detailed technical and quality documentation to CDSCO.

Risk Classification and License Requirements for Bone Grafting Material

• Device Class: C
• Intended Use: Filling, augmenting, or reconstructing periodontal or bony defects
• License Type: MD9 (Manufacturing License for Class C & D devices)
• Competent Authority: Central Licensing Authority, CDSCO

Due to the moderate risk associated with internal prosthetic replacements, the MD9 license process involves stringent evaluation, including product testing, document verification, and on-site audits.

Manufacturing License Process (MD9) for Bone Grafting Material

1. Test License (Form MD13): Initiate with applying for a test license, which typically takes 1.5 to 2 months. This allows for product testing as per CDSCO requirements.
2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to demonstrate compliance with safety and performance standards. You can find the list of testing laboratories here.
3. Document Preparation: Prepare comprehensive documentation, including Device Master File and Plant Master File, essential principles checklist, risk management files, and quality management system (QMS) documents.
4. License Application (Form MD7): Submit the MD9 application through the CDSCO MD Online Portal.
5. Audit: CDSCO inspectors conduct an on-site audit of your manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and QMS.
6. Query Resolution: Address any queries raised by the CDSCO or audit team promptly.
7. License Grant: Upon satisfactory review, CDSCO grants the MD9 license.

For detailed guidance on the MD9 process, refer to our comprehensive MD9 License Guide.

Manufacturing License Documents Required for Bone Grafting Material

To facilitate a smooth review, ensure submission of the following documents:

• Company Constitution: Incorporation certificate, partnership deed, or equivalent
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Credentials: CVs, qualifications, and experience
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed device description, specifications, manufacturing process, and quality control procedures. Learn how to create a DMF from our Device Master File Guide.
• Plant Master File (PMF): Manufacturing facility details, equipment, and quality management systems. Refer to our Plant Master File Guide.
• Essential Principles Checklist: Compliance with the Indian Medical Device Rules and international standards
• Risk Management File: Risk analysis and mitigation strategies as per ISO 14971. See practical tips in our Risk Management article.
• Test Reports: From CDSCO-approved labs
• Labels and Instructions for Use (IFU): Device labeling and user manuals
• Quality Management System (QMS) Documentation: ISO 13485:2016 certification and related procedures

Import License Process (MD15) for Bone Grafting Material

If you are an importer, the process differs slightly:

• No Test License Required: Unlike manufacturing, importers do not require a test license.
• Document Preparation: Gather manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution.
• License Application: Submit Form MD14 for import license (MD15) via the CDSCO MD Online Portal.
• Query Resolution and License Grant: Address any queries and await license issuance.

Government fees for import licenses vary by device class; for Class C, expect around $3000 per site and$1500 per product.

For more detailed import licensing, see our Import License Guide.

Timeline and Processing Duration

• MD9 License for Bone Grafting Material: Approximately 4 to 5 months from test license application to grant.
• Test License (MD13): 1.5 to 2 months
• Product Testing: Around 1 month depending on lab capacity
• Audit and Query Resolution: 1 to 1.5 months

Planning well in advance with complete documentation and proactive query management can help avoid delays.

Government Fees and Costs

• MD9 Application Fee: Rs 50,000 per application
• Fee per Product: Rs 1,000
• Test License (MD13): Separate fees as applicable

Budget for additional costs such as testing laboratory charges, audit fees, and consultancy if required.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all files, especially Device and Plant Master Files, are thorough and updated.
• Delays in Product Testing: Choose CDSCO-approved labs with proven turnaround times; schedule tests early.
• Audit Non-Compliance: Prepare your facility and QMS meticulously; conduct internal mock audits.
• Query Management: Assign dedicated personnel to respond promptly and accurately to CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO licensing landscape can be daunting, but with expert guidance, the process becomes manageable and efficient. We have supported over 500 companies in obtaining their MD9 licenses for complex devices such as bone grafting materials. Our services include document preparation, audit readiness, liaison with CDSCO officials, and post-license compliance.

Getting Started with Your CDSCO License Application for Bone Grafting Material

1. Assess Your Device Classification: Confirm Class C status using reliable resources like our Medical Device Classification guide.
2. Prepare Initial Documentation: Gather company constitution, premises proof, and technical staff details.
3. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved laboratories early.
5. Compile Device and Plant Master Files: Utilize our guides to ensure compliance.
6. Plan for Audit: Prepare your manufacturing site and QMS.
7. Submit MD9 Application (Form MD7): After successful testing and documentation.

Starting early and following a structured approach will significantly increase your chances of timely approval and successful market entry. For personalized assistance, feel free to contact our expert team to schedule a consultation.

Embark on your regulatory journey with confidence and leverage our decades of expertise to bring your bone grafting material device safely and compliantly to the Indian market.