CDSCO License for Removable skin staple

Comprehensive Guide to CDSCO Licensing for Removable Skin Staples (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted 500+ medical device companies, we understand how crucial it is to navigate the CDSCO licensing landscape efficiently. This guide focuses on Removable Skin Staples, a Class B dermatological and plastic surgery device, outlining the regulatory framework, specific license requirements, and actionable steps to enter the Indian market seamlessly.

Understanding Removable Skin Staples and Their Regulatory Importance

Removable skin staples are staple-like devices intended to temporarily connect external tissues to support healing. Unlike absorbable staples, these devices are removed after fulfilling their function. Given their direct contact with the skin and potential impact on patient safety, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is mandatory under the Medical Device Rules 2017.

CDSCO's notification 29/Misc./03/2020-DC (147) dated 26.7.2021 specifically includes Removable Skin Staples under Class B medical devices. Proper licensing ensures product safety, quality, and market access compliance.

CDSCO Regulatory Framework for Removable Skin Staples

Under the Medical Device Rules (MDR) 2017, devices are categorized by risk class, and Removable Skin Staples fall under Class B (low to moderate risk). Licensing for Class B devices is managed by the respective State Licensing Authority through the MD5 license pathway.

Manufacturers must comply with essential principles, including quality management systems (QMS), risk management, and product testing. Importers require a separate import license (MD15) granted by the Central Licensing Authority.

Risk Classification and License Requirements for Removable Skin Staples

• Risk Class: B
• License Type: MD5 Manufacturing License (Form MD3) via State Licensing Authority
• Testing License: MD13 (required prior to MD5 application)
• Testing: Mandatory product testing at CDSCO-approved laboratories
• Audits: Conducted by notified bodies listed by CDSCO

For detailed classification information, manufacturers may refer to the Medical Device Classification Guide.

Manufacturing License Process for Removable Skin Staples (MD5 License)

1. Apply for Test License (Form MD13): Initiate your journey by obtaining a test license, which typically takes 1.5-2 months. This license allows product testing and validation.
2. Product Testing: Conduct tests on Removable Skin Staples at CDSCO-approved testing laboratories. Refer to the List of Testing Laboratories for authorized facilities.
3. Documentation Preparation: Prepare comprehensive files including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System documents.
4. Apply for MD5 License (Form MD3): Submit your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Expect a facility audit by a CDSCO-approved notified body. You can check the Notified Bodies List to select your auditor.
6. Respond to Queries: Address any queries or deficiencies raised by the department or notified body promptly.
7. Grant of MD5 License: Upon successful review and audit, the State Licensing Authority issues the MD5 license allowing manufacturing of Removable Skin Staples.

Manufacturing License Documents Required for Removable Skin Staples

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification & Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing facility and equipment (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis (Risk Management Guide)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents such as ISO 13485 certification or internal SOPs

Import License Process for Removable Skin Staples (MD15 License)

For importers, the MD15 license is mandatory and issued by the Central Licensing Authority. The process generally takes 5-6 months and includes:

• Preparation of all required documents
• Application submission on the CDSCO MD Online Portal
• Resolution of department queries
• Final grant of license

Documents required include the current manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 2 to 4 weeks depending on laboratory capacity
• MD5 License Application and Audit: 1.5 to 2 months
• Total Time for MD5 License: Approximately 3-4 months

Planning ahead and timely submission of complete documentation can prevent delays.

Government Fees and Costs for MD5 License (Class B Device)

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs may include notified body audit fees, testing laboratory charges, and consulting fees if you engage expert support.

Common Challenges and Practical Solutions

• Incomplete Documentation: Ensure all files meet CDSCO format and content requirements. Use our Device Master File Guide and Plant Master File Guide for templates.
• Delays in Product Testing: Book slots early at government-approved labs and prepare samples meticulously.
• Audit Non-Compliance: Conduct pre-audit internal assessments to avoid non-conformities; train staff on regulatory requirements.
• Query Resolution: Respond promptly and with detailed evidence to queries raised by CDSCO or the notified body.

Expert Consultation and Support

Our extensive experience in securing CDSCO licenses for over 500 companies equips us to provide tailored support for Removable Skin Staples manufacturers and importers. From document preparation, product testing coordination, audit readiness, to query management, we ensure a streamlined approval process.

Getting Started with Your CDSCO License Application for Removable Skin Staples

1. Assess Your Device Classification: Confirm Class B status as per CDSCO guidelines.
2. Prepare Technical Documentation: Initiate drafting your Device Master File, Plant Master File, and Risk Management File.
3. Apply for Test License (MD13): Submit your initial application via the CDSCO MD Online Portal.
4. Coordinate Product Testing: Select a CDSCO-approved testing laboratory early.
5. Plan for Audit: Choose a notified body from the official list and schedule your facility audit.
6. Submit MD5 Application: Once test license and testing are complete, apply for the manufacturing license.

Taking these proactive steps will position your Removable Skin Staples for successful market entry in India under CDSCO compliance.

For personalized assistance or detailed consultancy, feel free to contact our regulatory experts who have guided hundreds of medical device companies through the CDSCO licensing journey.