CDSCO License for Wrist joint carpal scaphoid polymer prosthesis
Medical Device Information
Intended Use
Intended to be implanted to replace the carpal scaphoid bone of the wrist.
Comprehensive Guide to CDSCO Licensing for Wrist Joint Carpal Scaphoid Polymer Prosthesis
As a medical device manufacturer or importer aiming to introduce the Wrist Joint Carpal Scaphoid Polymer Prosthesis—a Class C orthopaedic implant intended to replace the carpal scaphoid bone of the wrist—navigating the Indian regulatory landscape is critical. With over 25 years of experience and having successfully assisted 500+ companies, we provide an authoritative roadmap to secure your CDSCO MD9 license, ensuring compliance and smooth market entry.
CDSCO Regulatory Framework for Orthopaedic Implants like Wrist Joint Prostheses
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Ministry of Health and Family Welfare. Orthopaedic implants such as your wrist joint carpal scaphoid polymer prosthesis fall under the ambit of the Medical Device Rules, 2017, notified via 29/Misc/3/2017-DC (292) dated 06.06.2018.
Given the implant's critical function and implantation nature, it is categorized as a Class C device, indicating moderate to high risk. This classification mandates a stringent approval process under the Central Licensing Authority.
Risk Classification and License Requirements for Class C Devices
Class C devices require an MD9 manufacturing license if produced domestically or an MD15 import license for imported devices. The MD9 license involves a thorough evaluation including product testing, documentation review, and inspections by CDSCO.
To understand device classification further or confirm any updates, manufacturers can refer to the Medical Device Classification guide.
Manufacturing License Process for Class C Devices (MD9 License)
The MD9 license application process is detailed and typically spans 4 to 5 months from start to finish. Here’s a stepwise outline:
Test License on Form MD13: Obtain a test license to conduct product testing at government-approved laboratories. This phase usually takes 1.5 to 2 months.
Product Testing: The wrist joint prosthesis must be evaluated for safety and performance at designated testing labs. Refer to the Testing Laboratories list for approved facilities.
Documentation Preparation: Compile all technical and regulatory documents, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
License Application Submission: Apply on the CDSCO MD Online Portal using Form MD7.
Audit and Inspection: CDSCO inspectors will conduct a detailed audit of your manufacturing facility and quality systems.
Queries and Clarifications: Respond promptly to any queries raised by the CDSCO or auditors.
Grant of License: Upon successful review, the MD9 license will be granted, allowing you to manufacture and market your device in India.
For detailed insights, consult our MD9 License Guide.
Manufacturing License Documents Required for Wrist Joint Prosthesis
Successful MD9 application demands comprehensive documentation, including but not limited to:
- Company Constitution and Incorporation Documents
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, materials, manufacturing process, and validations (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facilities and quality systems (Plant Master File Guide)
- Essential Principles Checklist ensuring compliance with Indian regulations
- Risk Management File adhering to ISO 14971 principles (Risk Management)
- Test Reports from Government Approved Labs
- Labels and Instructions for Use (IFU) in compliance with Indian regulations
- Quality Management System Documentation (ISO 13485:2016)
Import License Process for Wrist Joint Carpal Scaphoid Polymer Prosthesis (MD15 License)
For importers, the MD15 license is essential before marketing Class C devices in India. The process generally takes 5 to 6 months and involves:
- Preparation of required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, and other technical files.
- Submission of application on the CDSCO MD Online Portal using Form MD14.
- Review and queries resolution by CDSCO.
- Issuance of the MD15 import license.
Our comprehensive Import License Guide offers a step-by-step walkthrough.
Import License Documents Required
Key documents include:
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate (FSC) issued by the country of origin
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License (if applicable in India)
- Company Constitution and Address Proof
Timeline and Processing Duration
| License Type | Process Duration | Key Milestones |
|---|---|---|
| MD9 Manufacturing | 4 to 5 months | Test License (1.5-2 months), Testing, Audit |
| MD15 Import | 5 to 6 months | Document Review, Query Resolution |
Government Fees and Costs
| License Type | Application Fee (INR) | Per Product Fee (INR) | Notes |
|---|---|---|---|
| MD9 Manufacturing | 50,000 | 1,000 | Central Licensing Authority |
| MD15 Import | Varies by class | Varies by class | Class C & D: Rs 2,25,000 + Rs 1,12,500 per product approx. |
Note: Fees are subject to change; always verify with the latest CDSCO notifications.
Common Challenges and Practical Solutions
Delayed Testing: Testing at government labs can be backlogged. We recommend pre-booking slots and having backup approved labs identified.
Documentation Gaps: Incomplete or inconsistent device master files and risk management files often cause delays. Meticulous documentation adhering to regulatory standards is critical.
Audit Readiness: Unprepared facilities may fail audits. Conduct internal pre-audit assessments and implement corrective actions early.
Query Response Delays: Prompt and clear responses to CDSCO queries can significantly reduce processing time.
Expert Consultation and Support
Navigating CDSCO regulations for a Class C orthopaedic prosthesis requires specialized expertise. Our team offers end-to-end consultancy, from documentation to audit support, leveraging our deep experience to mitigate risks and accelerate approvals.
Getting Started with Your CDSCO License Application
Classify Your Device: Confirm the risk class and applicable license type.
Engage Testing Labs: Initiate the test license process and schedule product testing early.
Prepare Documentation: Compile and review all required files, including DMF and PMF.
Register on CDSCO MD Online Portal: Submit your application forms (MD7 for manufacturing, MD14 for import).
Plan for Audit: Prepare your facility and QMS for CDSCO inspection.
Respond to Queries Promptly: Assign a dedicated team member to handle CDSCO correspondence.
By following these actionable steps, you position your wrist joint carpal scaphoid polymer prosthesis for successful market entry in India.
For detailed guidance, visit the CDSCO MD Online Portal and explore our specialized resources to streamline your regulatory journey.
