CDSCO License for Surgical Punch/Bone Punch
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 surgical instrument used to punch holes in bone, typically for the purposes of biopsy procedures or for fixation procedures. The instrument can be ring handled, pistol grip or shaft-like in design. Ring handled or pistol grip designs feature extended shafts which terminate in a punch-like or mechanical jaw mechanism at the distal tip. The shaft-like instrument is a hollow tube, sharpened on one end, and is usually used with a trocar.
Comprehensive Guide to CDSCO Licensing for Surgical Punch (Bone Punch) - Class A Medical Device
As seasoned regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies successfully navigate CDSCO licensing, we understand the intricate regulatory pathways for medical devices like the Surgical Punch, a Class A device. This guide provides detailed, actionable insights to help manufacturers and importers obtain the necessary approvals swiftly and compliantly.
Introduction: Surgical Punch Device and Regulatory Importance
The Surgical Punch, also known as Bone Punch, is a critical surgical instrument used to create precise holes in bone during biopsy or fixation procedures. Available in ring-handled, pistol grip, or shaft-like designs, this device plays an essential role in orthopaedic and general hospital settings. Given its invasive use, albeit low risk (Class A), regulatory compliance under CDSCO ensures safety, efficacy, and quality for Indian patients.
CDSCO Regulatory Framework for Surgical Punch (Class A Device)
The Central Drugs Standard Control Organisation (CDSCO) administers medical device regulation in India. Surgical Punch falls under Class A—low risk—per the notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. This classification mandates obtaining an MD5 Manufacturing License, regulated by the State Licensing Authority.
Risk Classification and License Requirements
- Risk Class: A (Low risk)
- Regulatory Pathway: MD5 License (Form MD3 application)
- Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months end to end
For a Class A device such as the Surgical Punch, the MD5 license process is streamlined yet thorough, ensuring compliance with essential principles and quality standards.
Manufacturing License Process (MD5)
The MD5 license process involves several key steps:
- Obtain MD13 Test License: Apply for a test license on Form MD13 via the CDSCO MD Online Portal. This initial step takes around 1.5 to 2 months.
- Product Testing: Conduct mandatory testing of the Surgical Punch at government-approved laboratories. Refer to the updated list of Testing Laboratories for selection.
- Documentation Preparation: Compile necessary documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
- Submit MD5 License Application: File Form MD3 for MD5 license through the CDSCO portal.
- Audit by Notified Body: Coordinate with a notified body for a manufacturing site audit. Check the list of notified bodies to select a suitable auditor.
- Resolution of Queries: Address any observations or queries raised by CDSCO or the notified body.
- License Grant: Upon satisfactory compliance, the MD5 license is granted on Form MD5.
Manufacturing License Documents Required
Accurate and comprehensive documentation is crucial. For Surgical Punch, prepare the following:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification and Experience Details of Technical Staff
- Fire Safety NOC and Pollution Control NOC
- Device Master File (DMF) detailing device design, materials, and specifications (Device Master File Guide)
- Plant Master File (PMF) outlining manufacturing environment and processes (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with CDSCO standards
- Risk Management File highlighting hazard analysis and mitigation (Risk Management)
- Test Reports from government-approved laboratories
- Labeling Samples and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, typically ISO 13485:2016 certification
Import License Process (MD15) for Surgical Punch
If importing Surgical Punch into India, an MD15 Import License is required from the Central Licensing Authority. The process includes:
- Document preparation including Manufacturing License from country of origin, Free Sale Certificate, ISO and CE certificates, and company documents.
- Application submission on Form MD14 via the CDSCO MD Online Portal.
- Resolution of department queries.
- License grant on Form MD15.
The entire timeline is 5-6 months on average. For detailed guidance, explore our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate (FSC) or Certificate of Marketing Authorization
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution and Incorporation Proof
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| MD13 Test License | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Document Preparation | 2 to 3 weeks |
| MD5 License Application | 1 week |
| Audit by Notified Body | 2 to 3 weeks |
| Query Resolution & Grant | 2 to 3 weeks |
| Total Time | 3 to 4 months |
For imports, the MD15 license process generally takes 5-6 months.
Government Fees and Costs
MD5 Manufacturing License:
- Application Fee: ₹5,000
- Per Product Fee: ₹500
MD13 Test License: No separate fee; included in process
Import License MD15 (Class A): Approx. 50 per product
These fees are payable online via the CDSCO MD Online Portal.
Common Challenges and Practical Solutions
Delayed Testing Reports: We recommend pre-selecting accredited labs early and confirming turnaround times.
Incomplete Documentation: Use checklists and templates such as our Device Master File guide to ensure completeness.
Audit Non-compliance: Conduct internal mock audits and maintain updated QMS documents to avoid surprises during notified body inspections.
Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO or notified body queries.
Expert Consultation and Support
Navigating CDSCO licensing for Surgical Punch devices demands expertise due to evolving regulations and documentation complexity. Our consultancy offers:
- Tailored regulatory strategy for Class A devices
- Comprehensive document preparation and review
- Coordination with notified bodies and testing labs
- End-to-end application management through the CDSCO MD Online Portal
Getting Started with Your CDSCO License Application
- Classify Your Device: Confirm Surgical Punch as a Class A device using the Medical Device Classification tool.
- Set Up Infrastructure: Ensure your manufacturing premises meet CDSCO standards and appoint qualified technical staff.
- Register on CDSCO Portal: Create an account on the CDSCO MD Online Portal to initiate application submissions.
- Initiate MD13 Test License Application: Begin by applying for the test license to facilitate product testing.
- Engage Testing Labs and Notified Body: Schedule product testing and audits early to streamline timelines.
- Prepare Complete Documentation: Leverage our guides for Device and Plant Master Files to avoid rejections.
- Submit MD5 License Application: File Form MD3 after test reports and audits are complete.
By following these practical steps and leveraging expert support, manufacturers and importers can efficiently obtain CDSCO licensing for Surgical Punch devices, ensuring timely access to the Indian healthcare market with full regulatory compliance.
