CDSCO License for Manually-operated dermatome

Comprehensive Guide to CDSCO Licensing for Manually-Operated Dermatome (Class A Medical Device)

As specialists with over 25 years of navigating India’s medical device regulatory landscape, we have successfully guided more than 500 manufacturers and importers through the CDSCO licensing process. If you are looking to market a manually-operated dermatome—a hand-held surgical device integral to dermatological and plastic surgery—understanding the regulatory framework and requirements is critical. This device, classified as Class A (low risk), falls under CDSCO’s purview with specific licensing mandates.

Understanding the Manually-Operated Dermatome and Its Regulatory Importance

A manually-operated dermatome is designed to sever thin skin layers for grafting or resect minor skin lesions. Given its direct contact with patients during surgical procedures, regulatory oversight ensures safety, quality, and efficacy. The Government of India's notification 29/Misc./03/2020-DC (147) dated 26.7.2021 formally classifies this device under Class A dermatological and plastic surgery devices, subjecting it to the MD5 license requirements.

CDSCO Regulatory Framework for Manually-Operated Dermatome

India’s medical device regulation aligns with risk-based classification, where Class A devices are considered low risk. The Central Drugs Standard Control Organization (CDSCO) mandates obtaining an MD5 manufacturing license from the State Licensing Authority for Class A devices. This licensing ensures compliance with Good Manufacturing Practices (GMP), essential principles, and risk management protocols.

Manufacturers must also secure a Test License (Form MD13) before applying for the final manufacturing license. This step facilitates device testing in government-approved laboratories.

Risk Classification and License Requirements for Class A Devices

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License
• Applicable Authority: State Licensing Authority
• Application Form: MD3 for manufacturing license; MD13 for test license
• Timelines: Approximately 3-4 months including test license and audit
• Fees: Rs 5,000 per application + Rs 500 per product

For detailed device classification, you may refer to the Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD5) for Manually-Operated Dermatome

1. Apply for Test License (Form MD13): Initiate the process by applying for a test license, which permits you to send your product samples to government-approved testing laboratories.
2. Product Testing: Get the dermatome tested for compliance with Indian standards at CDSCO’s notified testing laboratories.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, risk management file, and QMS documents.
4. Application Submission: File the MD5 manufacturing license application (Form MD3) through the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an audit by a notified body from the official list to verify GMP compliance.
6. Resolution of Queries: Respond promptly to any queries raised by the licensing authority or notified body.
7. License Grant: Upon successful review and audit, the MD5 license is granted.

For a deep dive into the MD5 licensing process, our MD5 License Guide offers practical insights.

Manufacturing License Documents Required for Manually-Operated Dermatome

• Company Constitution (Memorandum and Articles of Association)
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Technical Staff Details and Qualifications
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File describing manufacturing facility and equipment (Plant Master File Guide)
• Essential Principles Checklist confirming device safety and performance
• Risk Management File aligned with ISO 14971 standards (Risk Management Guide)
• Test Reports from Government-Approved Laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, typically ISO 13485:2016 certification

Import License Process (MD15) for Manually-Operated Dermatome

If you are an importer rather than a manufacturer, the applicable license is the MD15 Import License, issued by the Central Licensing Authority. This process generally takes 5-6 months.

Import License Process Highlights:

• No test license required.
• Application submitted on Form MD14 via the CDSCO MD Online Portal.
• Documents include Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale license, and Company Constitution.
• Government fees vary by device classification; for Class A, $1000 per site +$50 per product.

Our Import License Guide provides detailed support.

Timeline and Processing Duration for MD5 License

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 4 weeks, depending on lab capacity
• Document Preparation: Concurrent with testing, typically 2 to 3 weeks
• Application Review and Audit: 4 to 6 weeks
• Total Estimated Time: Approximately 3 to 4 months

Government Fees and Cost Breakdown

• Test License (Form MD13): No separate fee but testing charges apply
• MD5 License Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product
• Audit and Testing Charges: Varies by notified body and laboratory

Budgeting for these costs upfront ensures a smoother process.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to laboratory backlogs. Solution: Engage with CDSCO-approved labs early and submit complete samples to avoid retesting.

Challenge: Incomplete or inconsistent documentation. Solution: Utilize detailed checklists and expert consultation to prepare the Device and Plant Master Files, Essential Principles Checklist, and Risk Management Files.

Challenge: Audit non-compliance issues. Solution: Conduct internal audits prior to notified body inspection and address GMP gaps proactively.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our team offers end-to-end support—from documentation preparation, liaising with notified bodies, to final license grant. Leveraging our experience with over 500 successful cases, we ensure compliance while minimizing time and cost overruns.

Getting Started with Your CDSCO License Application for Manually-Operated Dermatome

1. Initial Gap Assessment: Review your current manufacturing setup and documentation against CDSCO requirements.
2. Register on the CDSCO MD Online Portal: This is mandatory for all submissions.
3. Apply for Test License (MD13): Begin sample testing promptly to avoid delays.
4. Prepare Required Documentation: Engage with regulatory consultants or refer to our comprehensive guides on Device Master File and Plant Master File creation.
5. Schedule Notified Body Audit: Select an appropriate notified body early from the official list.

Taking these actionable steps early will position your company for a smooth and timely CDSCO MD5 license approval, enabling you to bring your manually-operated dermatome to the Indian market confidently and compliantly.