CDSCO License for Bone Tap

Introduction to Bone Tap and Its Regulatory Importance

Bone Tap is a specialized metal surgical instrument used to cut internal threads into bone, facilitating the secure insertion of bone screws. These screws anchor bone fragments, fixtures, or other devices to the bone, playing a critical role in orthopedic surgeries. Unlike implants, Bone Taps are reusable instruments falling under Class A, the lowest risk category, yet compliance with India's regulatory framework is mandatory for legal manufacturing and sale.

Given the device’s role in surgical procedures, regulatory approval from India's Central Drugs Standard Control Organisation (CDSCO) ensures patient safety and manufacturer accountability. Navigating the CDSCO licensing process efficiently is essential for manufacturers and importers aiming to capture the Indian market.

CDSCO Regulatory Framework for Bone Tap (Class A Medical Device)

Bone Tap is classified under Class A as per the CDSCO medical device classification system, categorized as a general hospital or orthopedic instrument. This classification subjects it to licensing requirements by the State Licensing Authority via the MD5 license pathway. The regulatory oversight includes compliance with Indian Medical Device Rules (2017), adherence to Essential Principles of safety and performance, and documentation of quality management systems.

For detailed classification, manufacturers can refer to the Medical Device Classification guide.

Risk Classification and License Requirements for Bone Tap

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License
• Licensing Authority: State Licensing Authority
• Application Form: MD3 for manufacturing license application

The MD5 license is specifically designed for Class A and B devices, ensuring that Bone Tap manufacturers meet minimum safety and quality standards.

Manufacturing License Process (MD5 for Bone Tap)

Our extensive experience with over 500 companies has shown that the MD5 license process for Bone Tap typically spans 3 to 4 months. The process breaks down as follows:

1. Test License (Form MD13): Obtain a test license valid for 1.5 to 2 months to facilitate product testing.
2. Product Testing: Conduct product testing at CDSCO-approved laboratories to validate compliance with Indian standards.
3. Documentation Preparation: Compile a comprehensive set of documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
4. Application Submission: Apply through the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: Engage with an approved notified body for a facility audit. Refer to the list of notified bodies for selection.
6. Resolution of Queries: Address any queries or observations from CDSCO or the notified body promptly.
7. Grant of License: Upon satisfactory compliance, the MD5 license is issued on Form MD5.

Manufacturing License Documents Required for Bone Tap

To streamline your application, gather the following essential documents:

• Company Constitution: Proof of legal entity and ownership.
• Proof of Premises Ownership or Lease: Valid documentation of manufacturing location.
• Technical Staff Details: Qualification and experience certificates of key personnel.
• Fire and Pollution NOCs: Compliance certificates from local authorities.
• Device Master File (DMF): Detailed product design, specifications, and manufacturing process. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Description of manufacturing facility and quality systems. Learn how to create a compliant PMF here.
• Essential Principles Checklist: Confirmation of compliance with CDSCO’s essential principles.
• Risk Management File: Identification and mitigation of product risks, aligned with ISO 14971 standards. See our Risk Management guide.
• Test Reports: Certificates from government-approved labs confirming product safety and efficacy.
• Product Labels and Instructions for Use (IFU): Clear, compliant labeling and user manuals.
• Quality Management System (QMS) Documents: Evidence of ISO 13485:2016 certification or equivalent.

Import License Process (MD15) for Bone Tap

If you are an importer of Bone Tap devices, the MD15 license granted by the Central Licensing Authority is mandatory. The process typically takes 5 to 6 months and involves:

1. Document Preparation: Compile manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, Device and Plant Master Files, Wholesale License, and company constitution.
2. Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Respond to any departmental queries.
4. License Grant: Receive the MD15 license on Form MD15.

Note: Test license is not required for import applications.

Costs vary by risk class; for Class A devices, fees are approximately $1000 per site and$50 per product.

For a detailed walkthrough, consult our Import License Guide.

Timeline and Processing Duration for Bone Tap Licensing

Government Fees and Costs for Bone Tap Licensing

• Test License Fee (MD13): Rs 5,000 per application
• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Additional Costs: Notified body audit fees (varies, generally Rs 50,000 to 1,00,000), testing lab fees (depending on tests required)

Budget planning should consider these fees alongside internal costs such as documentation, staffing, and consultancy.

Common Challenges and Solutions in Bone Tap Licensing

• Challenge: Delays in product testing due to lab backlog.

  • Solution: Pre-book testing slots at approved labs; refer to the Testing Laboratories list.

• Challenge: Incomplete or inconsistent documentation leading to query escalations.

  • Solution: Use checklists and expert review to ensure all documents meet CDSCO requirements before submission.

• Challenge: Audit non-compliance due to facility or QMS gaps.

  • Solution: Conduct pre-audit internal assessments and training; select notified bodies familiar with orthopedic instrument audits.

• Challenge: Understanding regulatory updates and notifications.

  • Solution: Stay current with official notifications such as 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022 affecting Bone Tap classification and requirements.

Expert Consultation and Support for Bone Tap Manufacturers

With over 25 years in medical device regulatory consulting and having supported 500+ companies, we provide tailored assistance for Bone Tap licensing. Our services include:

• End-to-end application preparation and submission
• Pre-audit readiness and QMS gap analysis
• Coordination with notified bodies and testing labs
• Regulatory updates and compliance monitoring

Our expertise ensures faster approvals, fewer queries, and compliance assurance.

Getting Started with Your CDSCO License Application for Bone Tap

1. Evaluate Your Product Class: Confirm Bone Tap classification as Class A.
2. Initiate Test License (Form MD13): Apply via the CDSCO MD Online Portal to start product testing.
3. Engage Testing Labs: Schedule testing with notified laboratories.
4. Prepare Documentation: Compile Device Master File, Plant Master File, risk management, QMS, and other required documents.
5. Select Notified Body: Identify and appoint a notified body for your state from the official list.
6. Submit MD5 Application (Form MD3): Complete and file your application online.
7. Prepare for Audit: Conduct mock audits and staff training.
8. Respond to Queries: Timely and detailed responses ensure smooth processing.

Embarking on this process with professional guidance reduces risks and accelerates your time to market. Contact us to leverage our proven expertise in CDSCO licensing for Bone Tap and allied orthopedic surgical instruments.