CDSCO License for Surgical Drape & Drape Accessories

Comprehensive Guide to CDSCO Licensing for Surgical Drape & Drape Accessories

Surgical drapes and drape accessories play a critical role in maintaining a sterile environment by protecting the surgical site from microbial and other contamination. Classified as a Class B medical device under the Indian regulatory framework, these personal protective equipment (PPE) products require strict adherence to CDSCO regulations to ensure patient safety and market access.

With over 25 years of experience supporting more than 500 companies in navigating CDSCO licensing, we provide you with an authoritative, step-by-step guide tailored to Surgical Drapes & Accessories to streamline your approval process.

CDSCO Regulatory Framework for Surgical Drapes & Accessories

The Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing in India. Surgical drapes & drape accessories fall under Class B devices, which are moderate risk PPE products. The regulatory compliance is enforced through the Medical Device Rules, 2017, and the subsequent notification (File No. 29/Misc./03/2020-DC (186), dated 13.09.2021).

Manufacturers of Class B devices must obtain an MD5 license issued by the respective State Licensing Authority. The process ensures compliance with quality, safety, and efficacy standards before market entry.

Risk Classification and License Requirements

Class B devices like Surgical Drapes are categorized as moderate risk. The specific license required is the MD5 Manufacturing License, which involves:

• Initial Test License (Form MD13)
• Product testing at government-approved laboratories
• Notified body audit of manufacturing premises
• Final license approval on Form MD5

This pathway ensures the device meets the Essential Principles Checklist and applicable standards.

Manufacturing License Process (MD5) for Surgical Drapes

The MD5 license process typically spans 3 to 4 months and involves these key phases:

1. Test License Application (Form MD13): Submit on the CDSCO MD Online Portal to obtain authorization for product testing. This phase takes about 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing at CDSCO-approved labs; refer to the Testing Laboratories list for options.

3. Documentation Preparation: Compile technical files including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. License Application (Form MD3): Apply for the MD5 license through the CDSCO portal.

5. Notified Body Audit: Engage an authorized notified body from the Notified Bodies List for manufacturing site inspection.

6. Query Resolution: Address any observations or queries raised by the licensing authority or notified body promptly.

7. License Grant: Upon successful compliance, the State Licensing Authority issues the MD5 license.

Manufacturing License Documents Required

Prepare the following comprehensive documentation to ensure smooth processing:

• Company Constitution/Registration Certificate
• Proof of Premises Ownership or Lease Agreement
• Details of Technical Staff with Qualifications
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, manufacturing process (read our DMF guide)
• Plant Master File (PMF) documenting facility details (learn more)
• Essential Principles Checklist demonstrating compliance with safety requirements
• Risk Management File specific to Surgical Drapes (risk management insights)
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Surgical Drapes

If importing Surgical Drapes into India, an MD15 Import License issued by the Central Licensing Authority is mandatory. The process generally takes 5 to 6 months and involves:

• Comprehensive documentation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Importers apply on the CDSCO MD Online Portal using Form MD14 for license application.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate confirming product acceptance in the exporting country
• ISO 13485:2016 Quality Management Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution and address proof

Timeline and Processing Duration

For imports, expect an overall duration of 5 to 6 months due to central authority processing and document verification.

Government Fees and Costs

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Fees vary by state, generally included within the overall process
• Notified Body Audit: Additional fees charged by the audit agency, ranging from Rs 50,000 to Rs 1,00,000 depending on the scope

Import license fees vary by device class; for Class B devices, approximately $2,000 per site plus$1,000 per product apply.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or inconsistent files. Our tip: follow a detailed checklist and cross-verify every document before submission.

• Audit Non-Compliance: Manufacturing sites often fall short on GMP aspects. Conduct internal pre-audit checks and engage a notified body early to identify gaps.

• Test Report Delays: Coordinate with CDSCO-approved labs early to schedule testing and avoid bottlenecks.

• Query Management: Prompt attention to CDSCO queries shortens approval times. Maintain a dedicated team for regulatory correspondence.

Expert Consultation and Support

Navigating CDSCO licensing can be complex and resource-intensive. Leveraging expert consultancy with proven experience accelerates approvals and minimizes risks. Our team has successfully supported 500+ clients, offering:

• Customized regulatory strategy for Surgical Drapes
• Document preparation and audit readiness
• Liaison with CDSCO and notified bodies
• Post-approval compliance support

Getting Started with Your CDSCO License Application

To initiate your MD5 license application for Surgical Drapes & Accessories, follow these practical steps:

1. Register on the CDSCO MD Online Portal: Create your company profile and familiarize yourself with the interface.

2. Arrange Product Testing: Contact one of the CDSCO-approved testing laboratories and schedule your product evaluation.

3. Prepare Technical Documentation: Utilize our Device Master File guide and Plant Master File guide to compile robust files.

4. Apply for Test License (MD13): Submit the form via the online portal.

5. Plan for Notified Body Audit: Select a notified body from the official list and initiate scheduling.

6. Maintain Transparent Communication: Designate a regulatory point person to respond swiftly to any queries.

By following these targeted steps and leveraging expert support, manufacturers and importers can achieve timely CDSCO licensing, ensuring surgical drapes reach Indian healthcare providers safely and compliantly.