CDSCO License for Skin Stapler
Medical Device Information
Intended Use
Skin Stapler is intended to be applied to close lacerations on the outer layer of the dermis.
Introduction to Skin Stapler and Its Regulatory Importance
Skin Staplers are vital devices in dermatological and plastic surgery procedures, designed specifically to close lacerations on the outer dermis efficiently and hygienically. Given their direct application on skin wounds, ensuring compliance with India’s regulatory framework is crucial for patient safety and market authorization. With the CDSCO’s strict regulatory mandates, obtaining the appropriate license is mandatory for manufacturers and importers aiming to distribute Skin Staplers in India.
With over 25 years of experience and having supported 500+ companies in navigating CDSCO licensing, we understand the nuances involved in acquiring the correct permissions smoothly and timely.
CDSCO Regulatory Framework for Skin Stapler (Class B Medical Device)
As per the Government of India’s Medical Device Rules, 2017, Skin Staplers fall under Class B risk category due to their moderate risk level, involving direct but non-invasive contact with the skin. The relevant notification governing this device is 29/Misc./03/2020-DC (147), dated 26.7.2021.
The regulatory oversight for Class B devices is managed at the State level by the State Licensing Authority. The license required is the MD5 Manufacturing License, processed via the CDSCO MD Online Portal.
Risk Classification and License Requirements for Skin Stapler
- Risk Class: B (Moderate Risk)
- Applicable License: MD5 (Manufacturing License)
- Application Form: MD3 for license application
Class B devices like Skin Staplers require a test license on Form MD13 initially, followed by product testing, document submission, and audit by a notified body before the MD5 license can be granted.
For a detailed understanding of medical device classification, visit our Medical Device Classification guide.
Manufacturing License Process for Skin Stapler (MD5)
Apply for Test License (Form MD13): Before manufacturing, apply for a test license which typically takes 1.5-2 months for approval. This allows limited production for testing purposes.
Product Testing: Conduct testing in government-approved laboratories to verify compliance with essential principles.
Document Preparation: Prepare required technical and quality documents such as Device Master File, Plant Master File, Risk Management File, etc.
Submit MD5 Application (Form MD3): File the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body authorized by CDSCO conducts a thorough audit of the manufacturing facility and documentation. You can check the list of notified bodies here.
Queries Resolution: Respond promptly to any queries from the notified body or licensing authority.
Grant of License: Upon successful audit and document verification, the MD5 license is issued.
Our comprehensive MD5 License Guide provides step-by-step assistance.
Manufacturing License Documents Required for Skin Stapler
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualification of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing product specifications and design (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing processes (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File (Risk Management Guide)
- Product Test Reports from CDSCO-approved labs (Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 preferred)
Import License Process for Skin Stapler (MD15)
Although this content focuses on manufacturing licensing, importers should note that the MD15 Import License is handled by the Central Licensing Authority, taking approximately 5-6 months. The application is submitted via the CDSCO MD Online Portal, requiring documents such as:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Device and Plant Master Files
- Wholesale License
- Company Constitution
For detailed guidance, review our Import License Guide.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (Form MD13) | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Document Preparation | 3 to 4 weeks |
| MD5 Application Processing | 6 to 8 weeks |
| Audit and Query Resolution | 3 to 4 weeks |
| Total Estimated Time | 3 to 4 months |
Planning ahead and timely submission of accurate documentation can significantly reduce delays.
Government Fees and Costs
- Test License (MD13): Included in MD5 process fees
- MD5 License Application Fee: Rs 5,000 per application
- Product-wise Fee: Rs 500 per product (for Skin Stapler, 1 product = Rs 500)
- Testing and Audit Costs: Variable depending on notified body and testing labs
Budgeting for product testing and audit fees is essential as these can vary but typically range between Rs 50,000 to Rs 1,00,000.
Common Challenges and Practical Solutions
Incomplete Documentation: Manufacturers often underestimate the detail required in Device Master Files and Risk Management documentation. Using our detailed guides helps reduce rejections.
Delays in Product Testing: Selecting CDSCO-approved labs early and scheduling tests promptly avoids bottlenecks.
Audit Non-conformities: Pre-audit internal reviews and mock audits can prepare your facility and team to meet all regulatory expectations.
Query Management: Respond to authority queries with comprehensive evidence and within stipulated timelines to prevent prolonged processing.
Expert Consultation and Support
With our vast experience supporting over 500 companies, we provide tailored regulatory consulting, document preparation assistance, audit readiness training, and liaison services with CDSCO authorities and notified bodies.
We recommend engaging with consultants early in your project to streamline the licensing journey and avoid costly delays.
Getting Started with Your CDSCO License Application for Skin Stapler
Assess Your Device Classification: Confirm your Skin Stapler’s Class B status and understand specific requirements.
Prepare Test License Application (Form MD13): Gather initial documents and submit via the CDSCO MD Online Portal.
Identify Approved Labs and Notified Bodies: Schedule product testing and audits early using the Testing Laboratories and Notified Bodies List.
Compile Technical Files: Utilize our Device and Plant Master File guides to prepare comprehensive documentation.
Develop Quality Management System: Ensure ISO 13485 compliance to strengthen your application.
Submit MD5 Application: Once testing is complete, submit Form MD3 through the MD Online portal.
Prepare for Audit: Conduct internal audits and gap analysis to ensure smooth regulatory inspection.
Embarking on your regulatory journey with clear steps and expert support will expedite your Skin Stapler’s successful market entry in India. Reach out to us for personalized assistance tailored to your product and business needs.
