CDSCO License for Instrument set for external fixation system
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
The instrument used for external fixation system. These include screw guide, allen key, half pin introducer, jig for fixator, minimally invasive spine surgery access tube, access tube holding handle, hex tightener, retractor blade, light source cable, optic fiber cable.
Comprehensive Guide to CDSCO Licensing for Instrument Set for External Fixation System (Class A Medical Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized instruments like the Instrument Set for External Fixation Systems. These devices—including screw guides, allen keys, half pin introducers, and minimally invasive spine surgery access tubes—play a critical role in orthopaedic procedures and are classified as Class A under the CDSCO framework. With over 25 years of experience and having supported 500+ companies through the CDSCO licensing process, we provide you with a detailed, actionable roadmap to secure your manufacturing or import license efficiently.
CDSCO Regulatory Framework for Instrument Set for External Fixation System
The Central Drugs Standard Control Organization (CDSCO) governs the registration and licensing of medical devices in India under the Medical Device Rules (MDR), 2017. Our device, categorized under General Hospital or Orthopaedic Instruments, is notified under the notification number 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.
As an essential orthopaedic instrument set, this device falls under Class A (low risk), which means regulatory oversight is primarily managed by the State Licensing Authority through the MD5 licensing process.
Risk Classification and License Requirements
Understanding your device’s risk class is vital:
- Class A: Low risk (e.g., external fixation instrument sets)
- Class B, C, D: Moderate to high risk devices
For Class A devices, the required license is the MD5 Manufacturing License (Application Form MD3), granted by the State Licensing Authority.
Manufacturers must first obtain a Test License (Form MD13) before applying for the MD5 license, ensuring product compliance through government-approved testing labs.
Manufacturing License Process (MD5) for Class A External Fixation Instrument Sets
Step 1: Obtain Test License (Form MD13)
- Submit an application on the CDSCO MD Online Portal
- Duration: Approximately 1.5 to 2 months
- Purpose: Legal permission to test your devices in an approved laboratory
Step 2: Product Testing
- Get your instrument set tested at CDSCO-approved labs. Refer to the Testing Laboratories list for authorized facilities.
- Testing ensures compliance with Indian standards and Essential Principles.
Step 3: Document Preparation
- Compile all required documents including Device Master File and Plant Master File.
- Prepare the Quality Management System (QMS) documentation aligned with ISO 13485.
- Complete the Essential Principles Checklist and Risk Management File.
Step 4: Application Submission (Form MD3)
- Submit your manufacturing license application along with all documents on the CDSCO portal.
Step 5: Audit by Notified Body
- A notified body conducts a thorough audit of your manufacturing site and quality systems.
- Refer to the Notified Bodies list to select an auditor.
Step 6: Queries and Clarifications
- Respond promptly to any queries raised by the CDSCO or the notified body to avoid delays.
Step 7: Grant of MD5 License
- Upon successful audit and documentation review, the State Licensing Authority issues the MD5 Manufacturing License.
Manufacturing License Documents Required for Instrument Set (Class A)
- Company Constitution Documents (e.g., MOA, AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (complete design and manufacturing details) – see our Device Master File Guide
- Plant Master File detailing manufacturing facility – refer to our Plant Master File Guide
- Essential Principles Checklist confirming compliance with Indian medical device regulations
- Risk Management File demonstrating hazard analysis and mitigation strategies – learn more about risk management
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- QMS Documentation (including SOPs, CAPA, internal audit reports, etc.)
Import License Process (MD15) for Instrument Sets
If you are an importer rather than a manufacturer, the process involves obtaining an MD15 Import License from the Central Licensing Authority. This process is slightly longer (5-6 months) and requires:
- Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Submit your application via the CDSCO MD Online Portal. Note that no test license is required for import applications.
Timeline and Processing Duration
| License Type | Duration | Key Activities |
|---|---|---|
| Test License MD13 | 1.5 - 2 months | Application, lab testing approval |
| Manufacturing License MD5 | 3 - 4 months total (including MD13) | Document prep, audit, query resolution |
| Import License MD15 | 5 - 6 months | Documentation, query resolution |
Manufacturers should anticipate a total of approximately 3-4 months to obtain the MD5 license, including mandatory product testing and audit stages.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 Manufacturing License | Rs 5000 | Rs 500 |
Additional costs include:
- Product testing fees charged by government-approved laboratories (varies by device complexity)
- Notified body audit fees
- Consultancy or document preparation support (optional but recommended)
Investing in thorough preparation upfront can prevent costly delays or rejections.
Common Challenges and Solutions
Challenge 1: Insufficient Documentation Many applicants face delays due to incomplete or inconsistent documentation, particularly in Device Master Files and Risk Management Files.
Solution: Utilize detailed checklists and templates, such as those provided in our Device Master File Guide, and conduct internal audits before submission.
Challenge 2: Delays in Product Testing Waiting for slots at government-approved labs can push timelines back.
Solution: Schedule testing early, and consider multiple laboratories from the Testing Laboratories list to secure availability.
Challenge 3: Audit Non-Compliance Audits by notified bodies can uncover gaps in QMS or facility compliance.
Solution: Perform pre-audit assessments and train your staff on compliance standards well in advance.
Expert Consultation and Support
Given the complexity of regulatory requirements and technical documentation, partnering with experienced consultants can make a substantial difference. We have successfully assisted over 500 companies in securing CDSCO licenses for devices like external fixation instrument sets, ensuring compliance and minimizing processing time.
Our services include:
- Gap analysis and document preparation
- Pre-audit readiness assessments
- Liaison with CDSCO and notified bodies
- End-to-end application management
Getting Started with Your CDSCO License Application for Instrument Set for External Fixation System
Conduct a Regulatory Assessment: Confirm your device classification and applicable regulations using resources like the Medical Device Classification Guide.
Prepare Essential Documentation: Develop your Device Master File and Plant Master File with precision.
Apply for Test License (MD13): Submit your test license application promptly to initiate product testing.
Schedule Product Testing: Engage with government-approved labs early to avoid bottlenecks.
Compile Manufacturing License Application: Assemble all required documents and submit your Form MD3 application via the CDSCO MD Online Portal.
Plan for Audit: Select an appropriate notified body and prepare your facility and staff for the audit.
Respond to Queries Promptly: Maintain open communication channels to resolve any regulatory questions swiftly.
Receive MD5 License: Once granted, maintain compliance through ongoing quality management and reporting.
Embarking on the CDSCO licensing journey for your Instrument Set for External Fixation System need not be daunting. With meticulous preparation, adherence to timelines, and expert guidance, you can successfully access the Indian medical device market and contribute to advancing orthopaedic care.
For personalized support, reach out to our regulatory experts today and leverage our 25+ years of experience to streamline your CDSCO licensing process.
