CDSCO License for Retractor Holder
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 mechanism to which surgical retractors are mounted to, in order for the retractors to hold back tissues.
Introduction to Retractor Holder and Its Regulatory Importance
The Retractor Holder is an essential surgical instrument designed to secure surgical retractors, enabling surgeons to hold back tissues effectively during procedures. Classified under General Hospital or Orthopaedic Instruments, this device plays a critical role in operative settings by enhancing precision and safety. Given its classification as a Class A medical device under CDSCO regulations, manufacturers and importers must comply with specific regulatory requirements to legally market the Retractor Holder in India.
Navigating the regulatory framework for medical devices in India is crucial for ensuring patient safety, maintaining quality standards, and achieving timely market entry. With over 25 years of experience and assisting more than 500 companies, we understand the intricacies of CDSCO licensing for Class A devices like the Retractor Holder and provide practical guidance to streamline your compliance journey.
CDSCO Regulatory Framework for Retractor Holder
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Since the notification dated 16.03.2022 (Notification No. 29/Misc./03/2020-DC (193)- Part-3), the Retractor Holder is regulated under the General Hospital or Orthopaedic Instruments category and classified as a Class A device.
Class A devices are considered low-risk and are regulated at the state level, requiring the manufacturer to obtain an MD5 license. Imports are regulated centrally under the MD15 license. Understanding these distinctions is vital for compliance.
Risk Classification and License Requirements for Retractor Holder
- Risk Class: A (Low Risk)
- Applicable License for Manufacture: MD5 License (Form MD3)
- Licensing Authority: State Licensing Authority
- Applicable License for Import: MD15 License (Form MD14)
- Regulatory Notifications: Notification 29/Misc./03/2020-DC (193)- Part-3 (16.03.2022)
For manufacturing, acquiring the MD5 license involves a multi-step process including test license acquisition, product testing at CDSCO-approved laboratories, and an audit by a notified body. For imports, an MD15 license issued by the central authority is mandatory.
Manufacturing License Process for Retractor Holder (MD5 License)
Obtaining the MD5 manufacturing license for the Retractor Holder typically takes 3-4 months. The process includes:
- Test License (Form MD13): Apply for a test license which takes approximately 1.5 to 2 months. This permits initial manufacturing for testing purposes.
- Product Testing: Conduct mandatory product testing at CDSCO-approved testing laboratories. You can find the updated list of Testing Laboratories on the CDSCO portal.
- Document Preparation: Compile required technical and quality documentation including Device Master File, Plant Master File, and Risk Management File.
- License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: Schedule and complete the audit by a notified body approved for MD5 audits. The list of Notified Bodies is available online.
- Query Resolution: Address any queries raised by CDSCO or the notified body promptly to avoid delays.
- Grant of MD5 License: Upon successful audit and documentation review, the license is granted.
Manufacturing License Documents Required for Retractor Holder
To ensure a smooth licensing process, prepare the following documents meticulously:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing processes. Refer to our comprehensive Device Master File guide.
- Plant Master File (PMF), describing the manufacturing site and quality management systems. Learn more from our Plant Master File Guide.
- Essential Principles Checklist
- Risk Management File documenting hazard analysis and mitigation strategies. For insights, see our Risk Management resource.
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification is highly recommended)
Import License Process for Retractor Holder (MD15 License)
For importers of the Retractor Holder, the MD15 license is mandatory and governed by the Central Licensing Authority. The process typically spans 5-6 months and includes:
- Document Preparation: Assemble required documentation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
- License Application (Form MD14): Submit the application via the CDSCO MD Online Portal.
- Query Resolution: Respond promptly to any departmental queries.
- Grant of MD15 License: Upon satisfactory review, the import license is issued.
Unlike manufacturing, no test license or product testing is required at the import stage.
Import License Documents Required for Retractor Holder
- Valid Manufacturing License issued by the country of origin
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Processing Duration |
|---|---|
| MD5 Manufacturing | 3 to 4 months (including test license, testing, audit) |
| MD15 Import | 5 to 6 months |
The test license required for manufacturing takes approximately 1.5 to 2 months. Product testing duration depends on laboratory schedules but typically fits within this timeframe.
Government Fees and Costs for Retractor Holder Licensing
| License Type | Fees Description | Cost (INR) |
|---|---|---|
| MD5 Manufacturing | Application Fee + Per Product Fee | Rs. 5,000 + Rs. 500 |
| MD15 Import | Site Fee + Per Product Fee (Class A device) | USD 1,000 + USD 50 |
Note: Costs are subject to revision. It is advisable to confirm fees on the CDSCO MD Online Portal before application.
Common Challenges and Practical Solutions
- Delayed Product Testing: Scheduling with government-approved labs can create bottlenecks. Plan testing appointments early and consider multiple labs to minimize delays.
- Incomplete Documentation: Thoroughly review document checklists and prepare Device and Plant Master Files in advance to avoid query rounds.
- Audit Non-compliance: Engage experienced notified bodies and conduct internal pre-audits to ensure readiness.
- Regulatory Updates: Stay updated with CDSCO notifications and guidelines, especially changes affecting device classification or documentation requirements.
Expert Consultation and Support
With over 25 years of experience assisting 500+ companies, we provide end-to-end CDSCO licensing support tailored to Class A devices like the Retractor Holder. Our services include:
- Documentation preparation and review
- Coordination with notified bodies and testing laboratories
- Application submission and follow-up through the CDSCO MD Online Portal
- Training on compliance and audit readiness
Engaging expert consultants significantly reduces approval timelines and mitigates risks of rejection.
Getting Started with Your CDSCO License Application
- Determine Device Classification: Confirm your Retractor Holder’s classification as Class A per the Medical Device Classification guidelines.
- Prepare Technical Documentation: Develop your Device Master File, Plant Master File, and Risk Management File using professional templates.
- Apply for Test License (Form MD13): Submit via the CDSCO portal to start manufacturing for testing.
- Coordinate Product Testing: Arrange testing at government-approved laboratories to obtain necessary test reports.
- Submit Manufacturing License Application (MD5): Use Form MD3 on the CDSCO MD Online Portal.
- Schedule and Complete Audit: Engage a notified body early for audit scheduling.
- Respond to Queries: Address any clarifications from CDSCO or auditors promptly.
Starting early and following these steps methodically will facilitate a smooth regulatory approval process for your Retractor Holder manufacturing or import business in India. Contact us today to leverage our expertise for your CDSCO licensing journey.
