CDSCO License for Surgical Drill & its attachment
Medical Device Information
Intended Use
The surgical drilling machine that, when rotated at an appropriate speed, will cut into bone creating a hole of the same dimension as the diameter of the bit. The attachment includes drill bit, drill guides, burr & handpiece.
Comprehensive Guide to CDSCO Licensing for Surgical Drill & Its Attachments (Class B Medical Device)
Surgical drills and their attachments are vital instruments in orthopaedic and general hospital settings, designed to precisely cut bone by rotating drill bits at controlled speeds. Given their critical role in surgeries and patient safety, these devices fall under Class B risk category, requiring stringent regulatory compliance under India’s Central Drugs Standard Control Organization (CDSCO). With over 25 years of experience and having successfully supported more than 500 companies, we offer you an in-depth, practical roadmap to securing your CDSCO license for Surgical Drill & its attachments.
Understanding the CDSCO Regulatory Framework for Surgical Drill & Attachments
Surgical drills, including drill bits, guides, burrs, and handpieces, are categorized as orthopaedic instruments in the general hospital device class. They are notified under Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022 by CDSCO. As Class B devices, they are considered low to moderate risk, which influences the licensing pathway.
According to the CDSCO’s medical device classification, Class B devices necessitate a manufacturing license under MD5 (Form MD3), granted by the State Licensing Authority. This ensures that the manufacturing process adheres to quality and safety standards before the products enter the Indian market.
You can verify this classification and other device details on the Medical Device Classification guide.
Risk Classification and License Requirements for Surgical Drill
| Risk Class | License Type | Licensing Authority | Timeline | Fees (INR) |
|---|---|---|---|---|
| Class B | MD5 License | State Licensing Authority | 3-4 months | Rs 5,000 + Rs 500 per product |
The entire process involves obtaining a Test License (Form MD13) first, followed by product testing, document preparation, audit by a notified body, and final license grant.
Step-by-Step Manufacturing License Process (MD5) for Surgical Drill & Attachments
Apply for Test License (Form MD13):
- Duration: 1.5 to 2 months.
- Purpose: To legally manufacture the device for testing purposes.
- Submit via the CDSCO MD Online Portal.
Product Testing:
- Conduct tests at CDSCO-approved government testing laboratories.
- Access the list of Testing Laboratories here.
Documentation and Application Preparation:
- Compile required documents including Device Master File and Plant Master File.
File Manufacturing License Application (Form MD3):
- Submit on the CDSCO portal.
Audit by Notified Body:
- Engage a notified body for an on-site audit.
- Check the list of notified bodies to select an appropriate auditor.
Resolve Queries:
- Address any observations or queries raised by CDSCO or the notified body promptly.
Grant of MD5 License:
- License issued in Form MD5 allowing commercial manufacturing.
For a complete walkthrough, our detailed MD5 License Guide elaborates on each step.
Essential Documents Required for MD5 Manufacturing License
- Company Constitution Documents: Incorporation certificate, partnership deed, or LLP agreement.
- Proof of Ownership/Lease of Premises: Property documents or valid lease agreement.
- Technical Staff Details: Qualification and experience certificates of responsible technical personnel.
- Fire NOC and Pollution Control NOC: To ensure safety and environmental compliance.
- Device Master File (DMF): Detailed device specifications, design, manufacturing process.
- Plant Master File (PMF): Description of manufacturing facilities and quality control systems.
- Essential Principles Checklist: Conformity to Indian regulatory requirements.
- Risk Management File: Hazard analysis and mitigation strategies following ISO 14971 principles.
- Test Reports: From CDSCO-approved laboratories.
- Labels and Instructions for Use (IFU): Compliant with CDSCO standards.
- Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification details.
Our expert Device Master File guide and Plant Master File guide provide templates and best practices.
Import License Process (MD15) for Surgical Drill & Attachments
If you are an importer seeking to bring Surgical Drills into India, the MD15 Import License is required, issued by the Central Licensing Authority.
- Timeline: Approximately 5-6 months.
- Application Form: MD14.
- No Test License required.
- Documents Required: Manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, wholesale license, company constitution.
Government fees vary by device class, with Class B devices typically charged at Rs 2000 per site and Rs 1000 per product.
Refer to our Import License Guide for detailed assistance.
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 15 - 30 days |
| Document Preparation | 2 - 3 weeks |
| Application Review & Audit | 1 - 1.5 months |
| Query Resolution & Grant | 2 - 4 weeks |
Total estimated time: 3 to 4 months for complete MD5 license acquisition.
Government Fees and Costs for MD5 License
- Application Fee: Rs 5,000 per application.
- Product Fee: Rs 500 per product.
Additional costs include testing fees at approved labs and notified body audit charges, which vary depending on the auditor selected.
Common Challenges and Practical Solutions
Challenge: Delays in product testing due to lab backlogs.
Solution: Plan testing schedules early, and consider alternative government-approved labs to expedite turnaround.
Challenge: Incomplete or inconsistent documentation causing audit queries.
Solution: Maintain rigorous internal document control systems and conduct mock audits before official inspections.
Challenge: Ambiguities in risk management documentation.
Solution: Implement a robust risk management framework aligned with ISO 14971, and utilize expert consultation to tailor risk files specific to surgical drills.
Our comprehensive Risk Management resource can help you build effective hazard controls.
Expert Consultation and Support
With decades of experience, we provide end-to-end regulatory consulting—from initial classification to final license grant. Our services include:
- Gap analysis of existing QMS and documentation.
- Preparation of Device Master and Plant Master Files.
- Coordination with notified bodies and CDSCO officials.
- Post-approval regulatory compliance support.
Engaging expert consultants early can significantly reduce approval timelines and mitigate compliance risks.
Getting Started with Your CDSCO License Application for Surgical Drill & Attachments
- Conduct a device classification review to confirm your surgical drill and attachments fall under Class B.
- Register on the CDSCO MD Online Portal to initiate your application.
- Prepare your Test License (MD13) application and submit it promptly.
- Simultaneously begin compiling essential documents such as your Device Master File, risk management files, and QMS certificates.
- Schedule product testing with CDSCO-approved labs early to avoid bottlenecks.
- Identify and contact a notified body for your audit to align timelines.
- Ensure your premises meet all safety and environmental norms to avoid delays in inspections.
Taking these proactive steps can streamline your path to market entry and compliance.
For personalized assistance, reach out to our regulatory experts who have successfully navigated the CDSCO licensing landscape for surgical drills and related devices.
By following these comprehensive guidelines, manufacturers and importers of Surgical Drill & Attachments can confidently approach the CDSCO regulatory process, ensuring timely approval and market readiness in India.
