CDSCO License for Osteotome

Introduction to Osteotome and Its Regulatory Importance

Osteotomes are essential handheld surgical instruments featuring a flat cutting edge designed to be struck with a hammer for precise bone trimming. Widely used in orthopaedic surgeries, including uncemented and cemented stem procedures, these devices fall under the General Hospital or Orthopaedic Instruments category. Given their critical role in surgical outcomes, securing a valid CDSCO license for Osteotomes is mandatory for manufacturers and importers aiming to market these devices in India.

Navigating the CDSCO regulatory framework can be complex, but with over 25 years of experience assisting 500+ companies, we provide expert insights to streamline your licensing journey.

CDSCO Regulatory Framework for Osteotome (Class A Medical Device)

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017 (MDR 2017). Osteotomes are classified as Class A devices, considered low-risk. Consequently, the licensing process is managed primarily by the State Licensing Authority via the MD5 license (Application Form MD3).

The relevant notification for Osteotomes is 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022, which confirms their classification and regulatory requirements.

Risk Classification and License Requirements for Osteotome

• Device: Osteotome
• Risk Class: Class A (Low Risk)
• License Type: Manufacturing License MD5 (Form MD3)
• Regulatory Authority: State Licensing Authority
• Applicable Rules: Medical Device Rules, 2017

Class A devices require a test license (Form MD13) before applying for the manufacturing license. The overall process includes product testing, document submission, audit by a notified body, and final approval.

For detailed device classification, you can refer to our Medical Device Classification guide.

Manufacturing License Process for Osteotome (MD5 License)

1. Obtain Test License (Form MD13): Initiate with an application for a test license, valid for 6 months, allowing product testing in government-approved laboratories.
2. Product Testing: Conduct mandatory testing of Osteotomes at CDSCO-approved labs to ensure compliance with essential principles.
3. Document Preparation: Compile the Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and other required documents.
4. Application Submission: File the manufacturing license application via the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: Arrange for an audit by a notified body from the authorized list (Notified Bodies List) to verify manufacturing processes and QMS.
6. Query Resolution: Address any observations or queries raised by the licensing authority or notified body promptly.
7. Grant of License: Upon satisfactory compliance, the State Licensing Authority issues the MD5 manufacturing license.

Manufacturing License Documents Required for Osteotome

• Company Constitution (MOA/AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) – detailed device specifications, manufacturing processes (Device Master File guide)
• Plant Master File (PMF) – manufacturing environment and equipment details (Plant Master File guide)
• Essential Principles Checklist demonstrating compliance with MDR
• Risk Management File highlighting identified risks and mitigation (Risk Management guide)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Labeling and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process for Osteotome (MD15 License)

While your Osteotome device falls under Class A, importers must apply for an import license (MD15) through the Central Licensing Authority. This process generally takes 5-6 months and does not require a test license.

Steps include:

1. Document Preparation: Compile all mandatory documents such as Manufacturing License, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
2. Application Submission: Submit the application on the CDSCO MD Online Portal using Form MD14.
3. Query Handling: Respond to any department queries expeditiously.
4. License Issuance: Upon satisfying all requirements, the Central Licensing Authority grants the MD15 import license.

More insights are available in our Import License Guide.

Import License Documents Required for Osteotome

• Valid Manufacturing License from the country of origin
• Free Sale Certificate issued by the regulatory authority
• ISO 13485:2016 Certification
• CE Certificate or other international approvals
• Device Master File and Plant Master File
• Wholesale License as applicable
• Company Constitution documents

Timeline and Processing Duration for Osteotome Licensing

The import license process generally takes 5-6 months.

Government Fees and Costs for Osteotome Licensing

• MD5 Manufacturing License:

  • Application Fee: Rs. 5000 per application
  • Product Fee: Rs. 500 per product (per variant/model)

• MD15 Import License:

  • For Class A devices: USD 1000 per site + USD 50 per product

Additional costs may include fees for testing, audit by notified bodies, and consultancy if engaged.

Common Challenges and Solutions

• Delayed Testing Approvals: Testing can become a bottleneck due to limited slots at government labs. We recommend early booking and parallel document preparation.
• Incomplete Documentation: Missing details in Device Master File or Risk Management Files often cause rejections. Utilize detailed templates and expert reviews to ensure completeness.
• Audit Non-compliance: Ensure your manufacturing facility and QMS are aligned with notified body requirements by conducting internal pre-audits.
• Query Resolution Delays: Assign dedicated personnel for swift response to regulatory queries to avoid prolonging the process.

Our experience shows that proactive planning and engaging expert consultants significantly mitigate these challenges.

Expert Consultation and Support

With more than 25 years of regulatory expertise and over 500 successful CDSCO license grants, we specialize in guiding manufacturers and importers of orthopaedic instruments like Osteotomes. Our services include:

• End-to-end license application preparation
• Device and Plant Master File development
• Risk management implementation
• Coordination with notified bodies and testing laboratories
• Regulatory compliance audits

Engaging an experienced consultant accelerates approval timelines and ensures regulatory compliance.

Getting Started with Your CDSCO License Application for Osteotome

1. Evaluate Your Device Classification: Confirm Osteotome as a Class A device under the latest CDSCO notification.
2. Initiate Test License Application: Apply for Form MD13 on the CDSCO MD Online Portal immediately to avoid delays.
3. Select Testing Laboratory: Choose a government-approved lab from the official Testing Laboratories list and schedule your product tests.
4. Prepare Documentation: Begin compiling the Device Master File, Plant Master File, and all QMS documents in parallel with testing.
5. Arrange Audit Readiness: Contact a notified body from the Notified Bodies List to schedule your manufacturing site audit.
6. Submit Manufacturing License Application: Once testing and documentation are complete, file Form MD3 via the online portal.
7. Monitor and Respond to Queries: Maintain open communication with CDSCO and the notified body to swiftly resolve any observations.

By following these practical steps and leveraging expert support, you can confidently secure your CDSCO license for Osteotomes, enabling successful entry into the Indian medical device market.

For further assistance, connect with our regulatory consulting team to ensure a smooth, compliant licensing process.