CDSCO License for Wire tensioner
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
An orthopaedic, manual hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a wire that is being implanted, usually as part of a system to provide corrective surgery to the spine. The product does not include orthopaedic implants.
Comprehensive Guide to CDSCO Licensing for Wire Tensioner Devices (Class A Medical Device)
At [Our Company], with over 25 years of expertise in medical device regulatory affairs, we've successfully empowered more than 500 manufacturers and importers to navigate the CDSCO licensing landscape. In this guide, we focus on the Wire Tensioner – a Class A orthopaedic instrument widely used in spine corrective surgery – and outline the precise steps and requirements for obtaining your CDSCO license.
Understanding the Wire Tensioner and Its Regulatory Importance
The Wire Tensioner is a manual, hand-held surgical tool designed for orthopaedic applications, specifically to apply controlled tension to wires implanted during spine surgeries. As per the CDSCO notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, it falls under Class A medical devices, categorized under General Hospital or Orthopaedic Instruments. While it is not an implant itself, its critical role in surgical procedures mandates strict regulatory oversight to ensure safety and compliance.
CDSCO Regulatory Framework for Wire Tensioner Devices
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India to ensure they meet the essential principles of safety, quality, and performance. For Class A devices like the Wire Tensioner, the regulatory authority is the State Licensing Authority, and the licensing process culminates in granting the MD5 Manufacturing License.
You can initiate your application through the CDSCO MD Online Portal, the official platform for all medical device regulatory submissions.
Risk Classification and License Requirements for Wire Tensioner
As a Class A device, the Wire Tensioner is considered low-risk. This classification aligns with the CDSCO’s risk-based approach, which simplifies the manufacturing license process compared to higher-risk Class C or D devices. The key license types relevant are:
- MD5 License (Manufacturing License for Class A/B devices) – mandatory for manufacturing within India.
- MD13 Test License – prerequisite for testing manufactured products before MD5 application.
For detailed classification, refer to our Medical Device Classification guide.
Manufacturing License Process for Wire Tensioner (MD5 License)
The MD5 license process is staged and typically takes 3 to 4 months from start to finish. Here’s the stepwise breakdown:
Application for Test License (MD13): Submit Form MD13 to the State Licensing Authority to obtain a test license for your Wire Tensioner device. This license allows you to manufacture sample products for mandatory testing.
Product Testing: Conduct product testing at government-recognized laboratories. View the list of approved Testing Laboratories here. Testing validates that the device meets safety and performance criteria.
Preparation of Documents: Compile all required documentation, including product technical files and manufacturing process details.
Submission of Application for MD5 License: Apply using Form MD3 via the CDSCO MD Online Portal.
Audit by Notified Body: The State Licensing Authority arranges an audit by a notified body to verify compliance. Check the list of notified bodies for audit assignments.
Resolution of Queries: Address any queries or observations raised during the audit or by the licensing authority promptly.
Grant of MD5 License: Upon satisfactory review, you receive the MD5 Manufacturing License on Form MD5.
Our detailed MD5 License Guide offers step-by-step insights.
Manufacturing License Documents Required for Wire Tensioner
To ensure a smooth application process, prepare the following mandatory documents:
- Company Constitution Documents: Registration certificate, Memorandum & Articles of Association.
- Proof of Ownership or Lease of Manufacturing Premises: Valid documents confirming your manufacturing site.
- Details of Technical Staff: Qualification and experience certificates of personnel involved in manufacturing.
- Fire NOC and Pollution Control NOC: Safety certificates from local authorities.
- Device Master File (DMF): Detailed technical documentation describing the Wire Tensioner design and specifications. Our Device Master File guide can help you prepare.
- Plant Master File (PMF): Documentation of manufacturing facilities and quality controls. Refer to our Plant Master File guide for preparation tips.
- Essential Principles Checklist: Demonstrates compliance with CDSCO's essential principles.
- Risk Management File: Risk analysis and mitigation strategies tailored for Wire Tensioners. Learn more about Medical Device Risk Management.
- Test Reports: Certified reports from approved laboratories confirming device safety.
- Labels and Instructions for Use (IFU): Sample labels and user manuals as per CDSCO guidelines.
- Quality Management System (QMS) Documents: ISO 13485 certification and internal quality procedures.
Import License Process for Wire Tensioner Devices (MD15 License)
If you plan to import Wire Tensioner devices into India, an MD15 Import License from the Central Licensing Authority is mandatory. The process is slightly longer, generally taking 5 to 6 months, and involves:
- Document preparation including manufacturing license of the overseas manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), and key technical files.
- Submission of Form MD14 via the CDSCO MD Online Portal.
- Resolution of departmental queries.
- Issuance of MD15 Import License.
For comprehensive guidance, review our Import License Guide.
Import License Documents Required
Key documentation includes:
- Manufacturer’s valid manufacturing license.
- Free Sale Certificate from the country of origin.
- ISO 13485:2016 certificate.
- CE Certificate or equivalent.
- Device Master File and Plant Master File.
- Wholesale license (if applicable).
- Company Constitution documents.
Timeline and Processing Duration
| Process Step | Estimated Duration |
|---|---|
| Test License (MD13) Application | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Document Preparation & Submission | 2 – 3 weeks |
| Audit and Queries Resolution | 1 – 1.5 months |
| Total Time for MD5 License | 3 – 4 months |
For import licenses (MD15), expect a total timeline of approximately 5–6 months.
Government Fees and Costs
For Class A devices like the Wire Tensioner, the fees associated with the MD5 license process are as follows:
- Application Fee: INR 5,000 per application.
- Product Fee: INR 500 per product.
These fees are payable online during application submission via the CDSCO portal.
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage government-approved labs early and verify their capacity to test your Wire Tensioner samples promptly.
Challenge 2: Incomplete Documentation
- Solution: Utilize our checklists and templates for Device Master Files and Plant Master Files to prevent rejections.
Challenge 3: Audit Non-Compliance
- Solution: Conduct a pre-audit internal review focusing on QMS adherence and facility compliance to avoid surprises during the notified body audit.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory liaison to respond quickly and comprehensively to CDSCO and notified body queries.
Expert Consultation and Support
Navigating the CDSCO licensing process can appear daunting due to evolving regulations and detailed requirements. Our seasoned consultants offer personalized support to:
- Assess your Wire Tensioner device classification.
- Prepare and review all technical and regulatory documentation.
- Coordinate with notified bodies and testing labs.
- Manage application submission and follow-up.
With over 500 successful CDSCO license applications under our belt, we bring unmatched expertise to streamline your market entry.
Getting Started with Your CDSCO License Application for Wire Tensioner
Register on the CDSCO MD Online Portal: Create your company profile and familiarize yourself with the interface.
Classify Your Device: Confirm the Wire Tensioner classification as Class A.
Prepare Preliminary Documents: Begin assembling your Device Master File and Plant Master File.
Apply for Test License (MD13): Submit your test license application to start manufacturing samples for testing.
Schedule Testing: Coordinate with approved labs early to avoid bottlenecks.
Plan for Audit: Engage a notified body and prepare your facility according to CDSCO requirements.
Submit MD5 License Application: Once test results are satisfactory, apply for the manufacturing license.
Embarking on your CDSCO licensing journey with thorough preparation and expert guidance ensures a smooth path to compliance and market success. Contact us today to discuss your Wire Tensioner device licensing needs.
Explore more about the CDSCO regulatory process and resources:
