CDSCO License for Drape adhesive.

Comprehensive Guide to CDSCO Licensing for Drape Adhesive (Class A Medical Device)

Drape adhesive is a specialized medical device designed to securely attach surgical drapes to the skin during procedures. Classified under Class A — the lowest risk category — this device falls within the dermatological and plastic surgery domain. Given its critical role in maintaining sterile fields in surgeries, obtaining timely and correct regulatory approval through the CDSCO (Central Drugs Standard Control Organization) is essential for manufacturers and importers targeting the Indian market.

With over 25 years of experience supporting 500+ companies in navigating CDSCO licensing, we provide you with a detailed, actionable roadmap tailored specifically for drape adhesive devices.

CDSCO Regulatory Framework for Drape Adhesive Devices

In India, all medical devices, including drape adhesives, are regulated under the Medical Device Rules (MDR) 2017, enforced by CDSCO. The device's classification as Class A means it is considered low risk and is regulated primarily by the State Licensing Authority through the MD5 license process.

The relevant notification for drape adhesive is 29/Misc./03/2020-DC (147), dated 26.7.2021, which explicitly lists it under dermatological and plastic surgery devices. Compliance with these regulations ensures patient safety, product quality, and market credibility.

Risk Classification and License Requirements

Drape adhesive is a Class A medical device. This classification impacts the licensing process significantly:

• License Type: MD5 Manufacturing License (Application Form MD3)
• Authority: State Licensing Authority
• Risk Level: Low

Class A devices require a test license (Form MD13) before the manufacturing license application, involving product testing, documentation, and factory audits.

For a detailed overview of medical device classification, refer to our Medical Device Classification guide.

Manufacturing License Process for Drape Adhesive (MD5)

The manufacturing license process for drape adhesive under MD5 involves several sequential steps:

1. Obtain Test License (Form MD13): Initiate with the test license application, which allows manufacturing a small batch for testing purposes.
2. Product Testing: Samples must be tested in CDSCO-approved laboratories to ensure compliance with safety and performance standards. You can find a list of approved testing laboratories here.
3. Prepare Documentation: Compile comprehensive documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documentation.
4. Application Submission: Submit the manufacturing license application (Form MD3) through the CDSCO MD Online Portal.
5. Audit by Notified Body: A third-party notified body audits the manufacturing facility and documentation. Refer to the list of notified bodies accredited for MD5 audits.
6. Queries and Clarifications: Address any queries raised by CDSCO or the notified body promptly.
7. Grant of License: Upon satisfactory review and audit, the State Licensing Authority grants the MD5 license (Form MD5).

For a detailed step-by-step process, refer to our MD5 License Guide.

Manufacturing License Documents Required

For drape adhesive, ensure you prepare and submit the following key documents:

• Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Records: Essential to demonstrate qualified personnel
• Fire NOC and Pollution Control NOC: Safety compliance certificates
• Device Master File: Detailed device description, specifications, manufacturing process, and controls (Device Master File Guide)
• Plant Master File: Information on manufacturing premises, equipment, and quality control (Plant Master File Guide)
• Essential Principles Checklist: Compliance with Indian medical device regulations
• Risk Management File: Identification and mitigation of device risks (Risk Management Guide)
• Test Reports: From CDSCO-approved laboratories
• Labels and Instructions for Use (IFU): As per regulatory standards
• Quality Management System Documents: Usually ISO 13485:2016 certified

Completeness and accuracy of documentation greatly reduce processing delays.

Import License Process for Drape Adhesive (MD15)

If you are an importer rather than a manufacturer, you need an import license (MD15) granted by the Central Licensing Authority. The process involves:

1. Document Preparation: Including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
2. Application Submission: File Form MD14 for import license through the CDSCO MD Online Portal.
3. Queries and Clarifications: Respond to any department inquiries promptly.
4. Grant of Import License: Issued on Form MD15.

Expect a timeline of approximately 5-6 months for import license approval.

Refer to our comprehensive Import License Guide for more details.

Import License Documents Required

• Valid Manufacturing License of the Device from the Country of Origin
• Free Sale Certificate: Confirming the device is freely sold in the country of origin
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License or equivalent
• Company Constitution Documents

Timeline and Processing Duration

The test license must be obtained before the manufacturing license application. Early preparation of documents and proactive communication can help meet or even shorten these timelines.

Government Fees and Costs

For Class A drape adhesive devices, the fee structure is as follows:

• MD5 Manufacturing License:

  • Application Fee: Rs 5,000
  • Per Product Fee: Rs 500

• Test License (MD13): Fee varies by state but generally included in the overall process

• Import License (MD15) Fees:

  • Site Fee: $1,000 (approx Rs 75,000)
  • Per Product Fee: $50 (approx Rs 3,750)

Note: Fees are subject to change; always verify current fees on the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with CDSCO-approved laboratories early to schedule testing. Prepare samples and documentation meticulously to avoid retests.

Challenge 2: Incomplete Documentation

• Solution: Use comprehensive checklists and expert reviews during document preparation. Our guides on Device Master Files and Plant Master Files can help.

Challenge 3: Audit Non-compliance

• Solution: Conduct internal mock audits before the notified body visit. Ensure all QMS and technical documentation are audit-ready.

Challenge 4: Query Resolution Delays

• Solution: Assign a dedicated regulatory liaison to respond promptly and comprehensively to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO requirements can be complex, especially for first-time manufacturers and importers. Our team, with 25+ years of regulatory expertise, has successfully helped over 500 companies secure CDSCO licenses efficiently.

We offer:

• Customized gap analysis
• Documentation preparation and review
• Liaison with CDSCO and notified bodies
• Audit readiness training
• End-to-end application management

Contact us early in your project to streamline your license approval process.

Getting Started with Your CDSCO License Application for Drape Adhesive

1. Assess Your Device Risk Class: Confirm Class A status for drape adhesive.
2. Prepare Test License Application: Gather initial documents and apply for Form MD13 via the CDSCO MD Online Portal.
3. Plan Product Testing: Coordinate with approved labs to schedule timely testing.
4. Compile Complete Documentation: Use our specialized guides to prepare Device Master File, Plant Master File, and Risk Management File.
5. Engage a Notified Body for Audit: Early engagement expedites audit scheduling.
6. Submit Manufacturing License Application: Apply for Form MD3 once test license and testing are complete.
7. Respond to Queries Promptly: Assign responsible personnel to avoid delays.
8. Receive License and Commence Manufacturing: After approval, you can legally manufacture and market drape adhesive in India.

Embarking on this journey with expert guidance significantly enhances your chances of timely CDSCO approval. For personalized support, connect with our regulatory consulting team today.

By following this comprehensive guide, manufacturers and importers of drape adhesive devices can confidently navigate the CDSCO licensing process and achieve successful market entry in India.