CDSCO License for Removable skin clip

Comprehensive Guide to CDSCO Licensing for Removable Skin Clips (Class B Medical Devices)

Navigating the regulatory pathway for medical devices in India is crucial for manufacturers and importers aiming to enter this rapidly growing market. A removable skin clip, categorized under dermatological and plastic surgery devices, is a Class B medical device as per CDSCO regulations. This clip is designed to connect skin tissues temporarily to aid healing and is non-absorbable.

With over 25 years of experience helping 500+ companies achieve seamless CDSCO licensing, we understand the nuances involved in securing your MD5 manufacturing license or import license. This detailed guide walks you through every step, including timelines, costs, documentation, and practical insights specific to removable skin clips.

CDSCO Regulatory Framework for Removable Skin Clips

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017, enforced since January 2020. Removable skin clips fall under Class B – low-moderate risk devices – under the dermatological and plastic surgery category, notified as per Notification No. 29/Misc./03/2020-DC (147) dated 26.07.2021.

Manufacturers seeking to produce these devices domestically must obtain an MD5 manufacturing license from the State Licensing Authority. Importers require an MD15 import license granted by the Central Licensing Authority.

Risk Classification and License Requirements for Removable Skin Clips

As a Class B device, removable skin clips demand a moderate level of regulatory scrutiny. Here’s what applies:

• Manufacturing License: MD5 License (Application Form MD3), issued by the State Licensing Authority.
• Testing: Mandatory product testing from government-approved laboratories.
• Audit: Notified body audit to verify compliance with QMS and essential principles.
• Import License: MD15 License (Form MD14) from CDSCO Central Authority.

For detailed risk classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Removable Skin Clips

The MD5 manufacturing license process involves several critical steps:

1. Test License Application (Form MD13): Apply for a test license to legally manufacture the device sample for testing. This stage typically takes 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-approved labs to demonstrate compliance with safety and performance standards. Check the list of testing laboratories.
3. Documentation Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Quality Management System (QMS) records, Essential Principles Checklist, and Risk Management File.
4. License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal along with all supporting documents.
5. Audit by Notified Body: The notified body conducts an on-site audit of manufacturing facilities and QMS compliance. Refer to the list of notified bodies for approved auditors.
6. Query Resolution: Address any queries raised during the audit or by CDSCO.
7. License Grant: Upon successful review and audit clearance, the MD5 license is issued.

The entire process generally takes 3 to 4 months from test license application to final license grant.

Manufacturing License Documents Required for Removable Skin Clips

Accurate and complete documentation submission is critical for smooth approval. Documents typically required include:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process (Guide to Device Master File)
• Plant Master File (PMF): Details of the manufacturing facility, equipment, and processes (PMF Guide)
• Essential Principles Checklist
• Risk Management File (per ISO 14971 standards) (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485:2016 compliance)

Ensuring each document is thorough and reflects the specific features of removable skin clips will prevent delays.

Import License Process (MD15) for Removable Skin Clips

For importers, the MD15 license is mandatory, and the process involves:

1. Document Preparation: Gather manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate or equivalent, Device Master File, Plant Master File, Wholesale License, and company constitution.
2. Application Submission: File the application using Form MD14 via the CDSCO MD Online Portal.
3. Query Resolution: Respond promptly to any queries raised by CDSCO.
4. License Grant: The import license (MD15) is granted by the Central Licensing Authority.

The typical timeline for MD15 license approval is approximately 5 to 6 months.

Import License Documents Required for Removable Skin Clips

Importers must submit:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or Certificate of Marketing Authorization
• ISO 13485:2016 Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution Documents

Meticulous preparation of these documents expedites the review process.

Timeline and Processing Duration

Timelines can vary based on completeness of submissions and audit scheduling.

Government Fees and Costs for Removable Skin Clips

For Class B devices like removable skin clips, the fees are as follows:

• MD5 License:
  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500
• MD15 Import License:
  • Site Fee: $1,000
  • Per Product Fee: $50

Additional costs include testing fees at government-approved labs and notified body audit charges, which vary by body selected.

Common Challenges and Solutions

• Incomplete Documentation: Missing items like Risk Management Files or Device Master Files cause delays. Our recommendation: use detailed checklists tailored for skin clips.
• Testing Delays: Limited slots at government labs can extend timelines. Solution: Schedule tests early and consider multiple approved labs.
• Audit Non-compliance: Facilities not meeting QMS or GMP standards risk audit failure. Pre-audit readiness assessments help mitigate this.
• Query Management: Delayed responses to CDSCO queries can stall approvals. Maintain a dedicated regulatory team to ensure prompt replies.

Addressing these proactively saves months in the approval process.

Expert Consultation and Support

With 25+ years of experience and over 500 successful CDSCO applications, we provide end-to-end support including:

• Regulatory strategy and classification guidance
• Preparation of Device and Plant Master Files
• Test license and product testing coordination
• Assistance with application submissions and audit readiness
• Query response management and compliance training

Our expertise ensures your removable skin clip reaches the Indian market efficiently and compliantly.

Getting Started with Your CDSCO License Application for Removable Skin Clips

1. Assess Device Classification: Confirm your device as Class B using the Medical Device Classification guide.
2. Prepare Documentation: Begin compiling your Device Master File, Plant Master File, Risk Management File, and QMS documents.
3. Apply for Test License: Submit your MD13 test license application through the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with a CDSCO-approved testing laboratory early.
5. Plan for Audit: Select a notified body and prepare your manufacturing site and QMS for audit.
6. Submit Manufacturing License Application: Use Form MD3 for MD5 license submission.
7. Respond to Queries Promptly: Maintain open communication with CDSCO and notified bodies.

Ready to embark on your CDSCO licensing journey? Partner with seasoned experts to navigate this complex process smoothly and compliantly. Contact us today to discuss your removable skin clip project and secure your CDSCO license with confidence.

For further reading, explore our comprehensive guides on MD5 Licenses and Device Master Files.