CDSCO License for Occlusive wound dressing.
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 occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device.
Comprehensive CDSCO Licensing Guide for Occlusive Wound Dressing (Class A Medical Device)
At our regulatory consultancy, with over 25 years of experience and having supported 500+ companies in India, we understand the nuances involved in securing CDSCO licenses for medical devices like occlusive wound dressings. As a Class A device under the dermatological and plastic surgery category, these dressings require adherence to specific regulatory frameworks to ensure safety, efficacy, and market access within India.
Understanding Occlusive Wound Dressing and Its Regulatory Importance
Occlusive wound dressings are designed to cover wounds, creating a moist environment conducive to healing while allowing gaseous exchange (oxygen and water vapor). Their non-resorbable and sterile or non-sterile nature classifies them as low-risk (Class A) medical devices according to CDSCO’s classification system.
Given their direct application on skin and potential impact on patient safety, obtaining the correct license is critical not only for legal compliance but also for building trust with healthcare providers and patients.
CDSCO Regulatory Framework for Occlusive Wound Dressing
Since the notification dated 26.07.2021 (Notification No. 29/Misc./03/2020-DC (147)), occlusive wound dressings fall under Class A devices. The licensing authority for manufacturing these devices is the State Licensing Authority, and the required license is the MD5 license, applied through Form MD3.
Manufacturers must comply with the Medical Device Rules, 2017, which outline quality management, testing, and documentation requirements to safeguard public health.
Risk Classification and License Requirements for Occlusive Wound Dressing
- Device Class: A (Low Risk)
- License Type: MD5 Manufacturing License
- Application Form: MD3
- Authority: State Licensing Authority
- Total Processing Time: Approximately 3 to 4 months (including test license, testing, audit)
Step-by-Step Manufacturing License Process for MD5 License
Obtain Test License (Form MD13): Before applying for the manufacturing license, manufacturers must first secure a test license to allow product testing. This step takes about 1.5 to 2 months.
Product Testing: Conduct product testing at government-approved laboratories to ensure compliance with applicable standards. Testing labs can be found via the official CDSCO Testing Laboratories list.
Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Apply for MD5 Manufacturing License: Submit the application on the CDSCO MD Online Portal using Form MD3.
Audit by Notified Body: Post-application, a mandatory audit by an approved notified body is conducted. Refer to the List of Notified Bodies for selecting the audit agency.
Resolution of Queries: Address any clarifications or observations raised by the licensing authority or notified body promptly.
Grant of License: Upon successful audit and document verification, the MD5 license (Form MD5) is issued.
Manufacturing License Documents Required for Occlusive Wound Dressing
- Company Constitution (e.g., Certificate of Incorporation)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Documents of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing device specifications and manufacturing process. Our Device Master File Guide provides detailed insights.
- Plant Master File (PMF) describing the manufacturing facility and quality control systems. Learn more in our Plant Master File Guide.
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard identification and mitigation strategies. For guidance, see Risk Management.
- Test Reports from accredited labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485 certification)
Import License Process (MD15) for Occlusive Wound Dressing
While our primary focus here is manufacturing, importers of occlusive wound dressings must apply for an MD15 import license via Form MD14. The process involves document submission, verification, and grant by the Central Licensing Authority over 5 to 6 months.
Required documents for import license include manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate (if available), Device Master File, Plant Master File, and wholesale license.
For detailed guidance, see our Import License Guide.
Timeline and Processing Duration
| Process Stage | Duration (Approx.) |
|---|---|
| Test License (Form MD13) | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks |
| Document Preparation | 3 to 4 weeks |
| Application Submission | Immediate upon document readiness |
| Audit by Notified Body | 1 month |
| Query Resolution | 2 to 3 weeks |
| License Grant (Form MD5) | Within 3 to 4 months total |
Government Fees and Costs
- Test License Fee: Included in application process; nominal.
- MD5 Manufacturing License Fee: Rs 5,000 per application plus Rs 500 per product.
- Testing Charges: Varies by laboratory; typically Rs 30,000 to Rs 50,000 depending on tests.
- Audit Fees: Payable to notified body; ranges from Rs 40,000 to Rs 70,000.
Budgeting for these costs upfront can prevent delays and ensure a smooth application process.
Common Challenges and Practical Solutions
- Delayed Testing Results: Engage with accredited labs early and confirm timelines to avoid bottlenecks.
- Incomplete Documentation: Utilize expert checklists for Device and Plant Master Files to ensure completeness.
- Audit Non-Compliance: Conduct internal audits prior to official audits to identify gaps.
- Query Management Delays: Assign a dedicated liaison to respond swiftly to regulatory queries.
Our extensive experience enables us to anticipate and resolve these hurdles effectively.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for first-time applicants. Our team provides end-to-end support, including document preparation, audit facilitation, and compliance training, ensuring your occlusive wound dressing reaches the Indian market without regulatory setbacks.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device as Class A and prepare for the MD5 license route.
- Initiate Test License Application: Apply for the test license (Form MD13) immediately on the CDSCO MD Online Portal.
- Engage Accredited Testing Laboratories: Schedule product testing early to align with licensing timelines.
- Prepare Comprehensive Documentation: Use our guides on Device Master File and Plant Master File as references.
- Plan for Audit: Select a notified body from the official list and prepare your facility and QMS accordingly.
- Submit MD5 License Application (Form MD3): Once testing and documentation are complete, proceed with the application.
Taking these strategic steps will streamline your regulatory journey and accelerate your product’s market entry. Contact us for personalized assistance tailored to your specific needs.
For additional resources and in-depth guides, please visit our MD5 License Guide.
