CDSCO License for Surgical Screw Driver
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A metal instrument designed to impart force on another instrument. The distal end is shaped to mate with the instrument being driven into some form of tissue. The proximal end is designed to absorb & transmit an impact force.

Comprehensive Guide to CDSCO Licensing for Surgical Screw Driver (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we understand the critical importance of navigating India's medical device regulatory landscape efficiently. The Surgical Screw Driver, classified as a Class A device under CDSCO regulations, is a vital instrument in orthopaedic and general hospital settings. This guide provides you with detailed, practical insights into obtaining the required CDSCO license, ensuring your manufacturing or import activities comply fully with Indian laws.
Understanding the Surgical Screw Driver and Regulatory Importance
A Surgical Screw Driver is a precision metal instrument designed to impart force on other instruments, typically to drive screws into tissue during surgeries. Given its invasive use, regulatory oversight ensures safety and efficacy. The device falls under the ‘General Hospital or Orthopaedic Instruments’ category and is classified as Class A, the lowest risk class per CDSCO classification but still subject to stringent controls.
The device is notified under Notification Number 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, mandating compliance with CDSCO licensing processes before manufacture or import into India.
CDSCO Regulatory Framework for Surgical Screw Driver (Class A Device)
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Class A devices like the Surgical Screw Driver require licensing at the State level through the MD5 license. This license ensures that manufacturers meet standards related to quality management, safety, and performance.
Compliance with the Medical Device Rules, 2017 and subsequent notifications is mandatory. The process involves product testing, document submission, audit by notified bodies, and finally, license grant.
Risk Classification and License Requirements
- Risk Class: A (Low risk)
- License Type: MD5 Manufacturing License (Application Form MD3)
- Authority: State Licensing Authority
For Class A devices, the MD5 license process includes obtaining a Test License (MD13), product testing in CDSCO-approved labs, followed by audit and license issuance.
For detailed understanding of device classification, manufacturers can refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Surgical Screw Driver
Secure Test License (Form MD13): Apply for a test license to produce the surgical screw driver samples for testing. This typically takes 1.5 to 2 months.
Product Testing: Samples must be tested at CDSCO-approved laboratories. Refer to the list of testing laboratories for authorized facilities. Testing ensures compliance with applicable standards.
Document Preparation: Compile technical documents, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, Test Reports, Labels, Instructions for Use (IFU), and Quality Management System (QMS) documents.
Application Submission: Submit the manufacturing license application using Form MD3 via the CDSCO MD Online Portal.
Audit by Notified Body: An audit of your manufacturing facility is conducted by a notified body. Check the list of notified bodies eligible for Class A device audits.
Query Resolution: Address any queries raised by the CDSCO or the notified body promptly to avoid delays.
License Grant: Upon satisfactory audit and document review, the State Licensing Authority issues the MD5 license.
For a comprehensive overview, our MD5 License guide outlines each step in detail.
Manufacturing License Documents Required
To ensure a smooth application process, prepare the following documents meticulously:
- Company Constitution: Incorporation certificates, partnership deed, or proprietorship proof.
- Proof of Ownership or Lease of Premises: Valid documents proving ownership or lawful tenancy.
- Technical Staff Details: Qualifications and experience certificates of responsible technical personnel.
- Fire NOC and Pollution Control NOC: Clearance certificates from relevant authorities.
- Device Master File (DMF): Detailed design and manufacturing process documents. Our Device Master File guide can assist in preparation.
- Plant Master File (PMF): Documentation of the manufacturing facility setup and quality controls. Refer to our Plant Master File guide for best practices.
- Essential Principles Compliance Checklist: Evidence of adherence to safety and performance principles.
- Risk Management File: Risk analysis and mitigation strategies as per ISO 14971. Guidance is available in our Risk Management guide.
- Test Reports: Laboratory testing certificates from CDSCO-approved labs.
- Labels and Instructions for Use (IFU): Drafts of product labels and user manuals.
- Quality Management System Documents: ISO 13485 certification and internal SOPs.
Import License Process (MD15) for Surgical Screw Driver
For importers, obtaining an MD15 license from the Central Licensing Authority is mandatory before bringing the surgical screw driver into India.
The process includes:
- Preparing comprehensive documentation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
- Submitting application on the CDSCO MD Online Portal using Form MD14.
- Resolution of queries raised by CDSCO.
- Grant of Import License in Form MD15 within approximately 5-6 months.
For detailed procedures and document requirements, see our Import License guide.
Timeline and Processing Duration
Process Stage | Duration |
---|---|
Test License (MD13) | 1.5 to 2 months |
Product Testing | 3 to 4 weeks |
Document Preparation | 2 to 3 weeks |
Audit and Inspection | 1 to 1.5 months |
Query Resolution | 2 to 4 weeks |
Total Estimated Time | 3 to 4 months |
Efficient coordination and prompt response to queries can significantly reduce delays.
Government Fees and Costs
- MD5 License Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product (Surgical Screw Driver in this case)
- Testing and Audit Costs: Variable; testing fees depend on the lab, and notified body audits may incur additional charges.
Budgeting for these fees upfront prevents unexpected financial hurdles.
Common Challenges and Solutions
- Delayed Test Reports: Plan early and choose CDSCO-approved labs with proven turnaround times.
- Non-compliance in Documentation: Utilize checklists and expert reviews to ensure completeness and accuracy.
- Audit Observations: Maintain robust quality management and training to pass audits smoothly.
- Query Response Delays: Assign dedicated personnel to handle CDSCO communications promptly.
Expert Consultation and Support
Given the complexities involved, partnering with experienced regulatory consultants can expedite approvals. We have guided 500+ manufacturers through successful MD5 licensing for devices like the Surgical Screw Driver. Our expertise covers document preparation, audit readiness, and liaison with CDSCO authorities.
Getting Started with Your CDSCO License Application for Surgical Screw Driver
- Assess Your Device Classification: Confirm your device’s Class A status and applicable regulatory pathway.
- Initiate Test License Application: Prepare your test samples and apply for the MD13 test license via the CDSCO MD Online Portal.
- Engage Approved Testing Labs: Coordinate with CDSCO-approved laboratories early to schedule testing.
- Compile Technical Documentation: Gather all required files including Device and Plant Master Files, risk files, and QMS documents.
- Schedule Pre-Audit Preparation: Conduct internal audits and process reviews before inviting notified bodies.
- Submit MD5 License Application: After successful testing and internal readiness, apply using Form MD3 online.
- Prepare for Audit and Respond to Queries: Ensure facility and documentation compliance to facilitate a smooth audit.
Taking these actionable steps early in your regulatory journey will position you for successful market entry.
For personalized assistance, contact our regulatory experts who specialize in CDSCO licensing for medical devices. Together, we can streamline your Surgical Screw Driver’s path to market in India.