CDSCO License for Dermatome
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 surgical knife used to harvest the skin for grafting. Either manual or electric-powered.
Comprehensive Guide to CDSCO Licensing for Dermatome Medical Devices
Dermatomes are essential surgical instruments designed to harvest skin grafts in dermatological and plastic surgery procedures. Classified as Class A devices under the Indian regulatory framework, these instruments—whether manual or electric-powered—must comply with the Central Drugs Standard Control Organisation (CDSCO) regulations to ensure safety, quality, and efficacy before entering the Indian market. With over 25 years of experience and having supported 500+ companies in successfully obtaining CDSCO licenses, we provide you an in-depth roadmap to streamline your license application process for Dermatomes.
CDSCO Regulatory Framework for Dermatome Devices
In India, medical devices are regulated under the Medical Device Rules, 2017, overseen by CDSCO. Dermatomes fall under the Class A category as per the notification number 29/Misc./03/2020-DC (147) dated 26.7.2021. Class A devices are considered low-risk and require a state-level manufacturing license known as the MD5 license. Compliance includes product testing, quality management system adherence, and audit by a notified body.
Risk Classification and License Requirements for Dermatomes
Dermatomes, categorized as Class A devices, must obtain the MD5 manufacturing license from the State Licensing Authority. The MD5 license process is specifically tailored for low-risk devices and involves the following key steps:
- Obtaining a Test License (Form MD13) to initiate product testing
- Product testing at government-approved laboratories
- Document preparation and submission
- Audit by a notified body
- Resolution of departmental and audit queries
- Final grant of manufacturing license (Form MD5)
For detailed classification insights, manufacturers can refer to the Medical Device Classification guide.
Manufacturing License Process (MD5) for Dermatome Devices
Apply for Test License (Form MD13): Initiate with a test license to conduct mandatory product testing. This stage takes approximately 1.5 to 2 months.
Product Testing: Conduct tests at CDSCO-approved labs to verify safety and compliance. Refer to the official Testing Laboratories list for selecting an authorized lab.
Document Preparation: Compile all technical and quality documents, including Device Master File and Plant Master File.
Submission of MD5 Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal with all requisite documents.
Notified Body Audit: Undergo an audit by a notified body listed here to assess compliance with Good Manufacturing Practices (GMP).
Respond to Queries: Address any queries raised by the department or the notified body promptly.
License Grant (Form MD5): Upon satisfactory review, the State Licensing Authority issues the manufacturing license.
The entire process typically takes 3 to 4 months from test license application to final license grant.
Manufacturing License Documents Required for Dermatomes
To streamline your application, ensure the following documents are prepared meticulously:
- Company Constitution and Incorporation Certificate
- Proof of Premises Ownership or Lease Agreement
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing the dermatome’s design and specifications (Device Master File Guide)
- Plant Master File (PMF) demonstrating manufacturing facility compliance (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with regulatory standards
- Risk Management File illustrating hazard analysis and mitigation strategies (Risk Management Reference)
- Test Reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 certified
Import License Process (MD15) for Dermatomes
For importers seeking to bring Dermatomes into India, the MD15 import license is mandatory. This license is granted by the Central Licensing Authority and does not require a test license. The process includes:
- Preparation of comprehensive documentation
- Submission of application via the CDSCO MD Online Portal
- Resolution of queries raised by CDSCO
- License grant on Form MD15
Key documents for import license include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license
- Company Constitution
The import license process takes approximately 5 to 6 months. For detailed guidance, visit the Import License Guide.
Timeline and Processing Duration
| License Type | Process Steps | Estimated Duration |
|---|---|---|
| MD5 Manufacturing | Test License → Product Testing → Application → Audit → Query Resolution → License Grant | 3 to 4 months |
| MD15 Import | Document Preparation → Application → Query Resolution → License Grant | 5 to 6 months |
Government Fees and Costs for Dermatome Licensing
MD5 License (Class A device):
- Application Fee: ₹5,000
- Per Product Fee: ₹500
MD15 Import License (Class A device):
- Site Fee: Approx. USD 1,000 (~₹75,000)
- Per Product Fee: Approx. USD 50 (~₹3,750)
These fees are payable online via the CDSCO MD Online portal during application submission.
Common Challenges and Solutions
Challenge: Delays in test license approval and product testing
Solution: Engage early with government-approved testing labs and ensure all test samples and documentation are complete to avoid resubmissions.
Challenge: Preparing comprehensive documentation such as Device Master File and Risk Management File
Solution: Utilize expert templates and guides like our Device Master File Guide and Risk Management Strategies to ensure compliance.
Challenge: Navigating the notified body audit
Solution: Pre-audit your manufacturing facility against CDSCO requirements and select notified bodies from the official Notified Bodies list with proven expertise in Class A devices.
Challenge: Query resolution turnaround time
Solution: Maintain a dedicated regulatory contact to address CDSCO queries promptly, ensuring minimal back-and-forth.
Expert Consultation and Support
Our team has supported over 500 companies in medical device regulatory approvals, including Dermatomes. We provide tailored services such as:
- Gap analysis and regulatory strategy
- Comprehensive documentation preparation
- Coordination with notified bodies and testing labs
- Application submission and query management
Leveraging our experience accelerates your market entry and reduces compliance risks.
Getting Started with Your CDSCO License Application for Dermatomes
- Assess your device classification: Confirm Dermatome as Class A via CDSCO notifications.
- Initiate Test License Application: Submit Form MD13 on the CDSCO MD Online Portal.
- Select Testing Laboratory: Choose an approved lab from the official list to schedule product testing.
- Prepare Documentation: Start compiling Device Master File, Plant Master File, risk management, and QMS documents.
- Engage a Notified Body: Identify and contact an appropriate notified body early for audit scheduling.
- Submit MD5 Application: Post-testing, file Form MD3 for the MD5 manufacturing license.
- Monitor Application Progress: Track your application status regularly on the CDSCO portal and respond to queries promptly.
By following this structured approach, manufacturers and importers of Dermatomes can efficiently navigate the CDSCO licensing pathway, ensuring compliance and timely market access in India.
