CDSCO License for Growth-correction orthopaedic fixation plate kit
Medical Device Information
Intended Use
A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.
Comprehensive Guide to CDSCO Licensing for Growth-Correction Orthopaedic Fixation Plate Kits (Class C Medical Device)
Manufacturers and importers aiming to introduce the Growth-correction orthopaedic fixation plate kit into the Indian market must navigate the CDSCO regulatory framework carefully. This device, categorized under Pediatrics and Neonatology, is classified as a Class C medical device due to its implantable nature and critical role in correcting long bone deformities in pediatric patients. Understanding the regulatory process, timelines, costs, and document requirements is vital to ensure timely market entry and compliance.
CDSCO Regulatory Framework for Growth-Correction Orthopaedic Fixation Plate Kits
This device falls under the purview of the Central Drugs Standard Control Organisation (CDSCO), the regulatory authority responsible for medical device approvals in India. Since it is an implantable device used in pediatric orthopaedics, it is classified as Class C, which carries moderate to high risk, necessitating a stringent licensing process.
The regulatory controls are guided by the Medical Device Rules, 2017, and the specific notification File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021, which governs its classification and regulatory requirements.
Risk Classification and License Requirements
- Device Risk Class: C (Moderate to high risk)
- License Type: MD9 Manufacturing License (for domestic manufacturing)
- Licensing Authority: Central Licensing Authority (CDSCO HQ)
Class C devices require a manufacturing license under Form MD7 (MD9 license) and must comply with rigorous standards, including product testing, quality management systems, and audits.
Manufacturing License Process (MD9) for Class C Devices
The complete process typically spans 4 to 5 months and involves the following key stages:
Test License Application (Form MD13): Before the manufacturing license, a test license is mandatory. This allows you to manufacture samples for testing and usually takes 1.5 to 2 months to be granted.
Product Testing: Samples must be tested in CDSCO-approved laboratories to verify compliance with standards. Refer to the Testing Laboratories list to identify suitable facilities.
Document Preparation: Prepare comprehensive documentation including Device Master File and Plant Master File, essential principles checklist, risk management file, and quality management system (QMS) documentation.
License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal with all supporting documents.
CDSCO Audit: Central licensing authority conducts an on-site audit to verify compliance with GMP, QMS, and technical requirements.
Query Resolution: Address any queries raised during the audit or application review promptly.
Grant of License (Form MD9): Upon satisfactory review and audit, the license is granted.
For a detailed walkthrough, see our MD9 License Guide.
Manufacturing License Documents Required for Growth-Correction Orthopaedic Fixation Plate Kits
- Company Constitution Documents: Certificate of incorporation, partnership deed, etc.
- Proof of Ownership/Lease of Manufacturing Premises: To establish the manufacturing site.
- Technical Staff Details: Qualifications and experience of key technical personnel.
- Fire NOC and Pollution Control NOC: Compliance with local safety and environmental norms.
- Device Master File (DMF): Detailed description of the device, manufacturing process, and specifications. Our comprehensive Device Master File guide can help.
- Plant Master File (PMF): Details on the manufacturing facility setup and quality controls. Refer to our Plant Master File Guide.
- Essential Principles Checklist: Demonstrating compliance with Indian Essential Principles of Safety and Performance.
- Risk Management File: Risk analysis, risk control measures, in line with ISO 14971 principles. See our Risk Management guide.
- Test Reports: From CDSCO-approved labs confirming product safety and efficacy.
- Labels and Instructions for Use (IFU): Drafts compliant with regulatory guidelines.
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and related SOPs.
Import License Process (MD15) for Growth-Correction Orthopaedic Fixation Plate Kits
For companies intending to import this device, an Import License under Form MD14 (MD15 license) must be obtained from CDSCO Central Licensing Authority. The process generally takes 5 to 6 months and involves:
- Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, Device and Plant Master Files.
- Application submission through the CDSCO MD Online Portal.
- Review and resolution of departmental queries.
- Grant of Import License (Form MD15).
Government fees vary based on risk class and number of products. For Class C devices like Growth-correction orthopaedic fixation plate kits, fees are approximately INR 2,20,000 (USD 3000) per site and INR 1,10,000 (USD 1500) per product.
Detailed guidance is available in our Import License Guide.
Timeline and Processing Duration
| Process Stage | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 1 month (can overlap) |
| Manufacturing License (MD9) | 1.5 - 2 months |
| Total Estimated Time | 4 - 5 months |
For imports, the process typically extends to 5-6 months due to additional documentation and review.
Government Fees and Costs
MD9 Manufacturing License:
- Application fee: INR 50,000
- Per product fee: INR 1,000
MD13 Test License:
- Usually included within the manufacturing license fees but may vary
MD15 Import License:
- For Class C: INR 3,00,000 per site + INR 1,50,000 per product
Additional costs include:
- Product testing fees at government-approved labs
- Costs related to audits and consultancy
- Documentation preparation and translations if required
Common Challenges and Solutions
- Delayed Test Reports: Lab backlogs can cause delays; plan early and engage multiple testing labs if possible.
- Incomplete Documentation: Missing or inconsistent documents are a common cause of queries; use detailed checklists and expert reviews.
- Audit Non-Compliance: Pre-audit readiness assessments significantly reduce risks of non-compliance findings.
- Clarity on Device Classification: Misclassification leads to process delays; consult the CDSCO guidelines or our Medical Device Classification resource to confirm.
Expert Consultation and Support
With over 25 years of experience assisting 500+ companies, we offer end-to-end support including:
- Detailed gap analysis of your current compliance status
- Assistance in preparing Device and Plant Master Files
- Guidance on risk management implementation
- Coordination with notified bodies and CDSCO inspectors
- Comprehensive application preparation and query handling
Our proven expertise helps clients reduce approval timelines and avoid costly rejections.
Getting Started with Your CDSCO License Application
- Assess your device classification: Confirm your Growth-correction orthopaedic fixation plate kit is Class C.
- Initiate Test License (Form MD13) application: Apply through the CDSCO MD Online Portal to start manufacturing samples.
- Schedule product testing: Contact approved labs early to avoid bottlenecks.
- Begin documentation preparation: Utilize our Device and Plant Master File guides to ensure completeness.
- Plan for audit readiness: Engage consultants for mock audits and compliance checks.
- Submit your manufacturing license application (Form MD7): Once all prerequisites are met.
Starting early and following a structured approach is key to success. Reach out to experienced regulatory consultants to streamline your journey to Indian market approval for your pediatric orthopedic implant.
For more detailed assistance, visit our MD9 License Guide or contact us directly to kickstart your CDSCO license application with confidence.
