CDSCO License for Surgical apparel.

Introduction to Surgical Apparel and Regulatory Importance

Surgical apparel plays a critical role in maintaining aseptic conditions during surgical procedures. These devices, intended to be worn by operating room personnel, protect both patients and staff from the transfer of microorganisms, bodily fluids, and particulates. Given their direct involvement in infection control, surgical apparel falls under Class A medical devices in India — the lowest risk category but still requiring stringent regulatory compliance.

Navigating the CDSCO regulatory framework is essential for manufacturers and importers to legally market surgical apparel within India. With over 25 years of experience and having supported 500+ companies in acquiring CDSCO licenses, we provide you with detailed, actionable guidance to streamline your licensing journey.

CDSCO Regulatory Framework for Surgical Apparel

The Central Drugs Standard Control Organization (CDSCO) governs the regulatory approval of medical devices in India. Surgical apparel, classified under dermatological and plastic surgery devices, is notified under the Gazette Notification 29/Misc./03/2020-DC (147) dated 26.7.2021.

As a Class A device, surgical apparel is regulated at the state level through an MD5 manufacturing license. Importers must also comply with CDSCO import licensing requirements if bringing products into India.

Risk Classification and License Requirements for Surgical Apparel

• Risk Class: A (Low Risk)
• License Type for Manufacturing: MD5 License (Form MD3 for application)
• Regulatory Authority: State Licensing Authority
• Applicable Regulations: Medical Devices Rules, 2017

This classification means the process is comparatively less complex than higher-risk devices but still mandates compliance with all regulatory prerequisites, including testing, audit, and documentation.

Manufacturing License Process (MD5) for Surgical Apparel

1. Obtain Test License (Form MD13): Before applying for MD5, manufacturers must secure a test license for surgical apparel, which takes approximately 1.5 to 2 months. This license allows production of limited devices for testing purposes.

2. Product Testing: Surgical apparel must be tested in government-approved laboratories to confirm compliance with applicable standards (e.g., microbial barrier properties, biocompatibility).

3. Documentation Preparation: Prepare comprehensive technical documentation, including Device Master File, Plant Master File, Risk Management File, and quality management system (QMS) documents.

4. Application Submission: Submit the MD5 license application (Form MD3) via the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body audits the manufacturing facility and system compliance. Check the list of notified bodies for qualified auditors.

6. Respond to Queries: Address any observations or queries raised by the licensing authority or notified body.

7. License Grant: Upon successful audit and document approval, the MD5 manufacturing license is granted on Form MD5.

Manufacturing License Documents Required for Surgical Apparel

• Company Incorporation Certificate and Constitution
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Qualified Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File — detailed product specifications and manufacturing process (Device Master File Guide)
• Plant Master File — factory layout, machinery, and infrastructure (Plant Master File Guide)
• Essential Principles Checklist for Medical Devices
• Risk Management File describing hazard analysis and mitigation (Risk Management)
• Test Reports from Government Approved Laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485:2016 recommended)

Import License Process (MD15) for Surgical Apparel

Although surgical apparel is a Class A device, importers must obtain an MD15 import license from CDSCO’s Central Licensing Authority before marketing the product in India.

1. Document Preparation: Assemble required import documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE certificate if applicable, Device and Plant Master Files.

2. License Application: Submit Form MD14 application for MD15 license through the CDSCO MD Online Portal.

3. Query Resolution: Address any clarifications sought by the authority.

4. License Issuance: Once compliant, MD15 license is granted.

Import License Documents Required for Surgical Apparel

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate or Equivalent
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License for Importer
• Company Constitution and Ownership Proof

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 4 weeks depending on lab availability
• MD5 Manufacturing License: 3 to 4 months total (including audit and query resolution)
• MD15 Import License: 5 to 6 months

Realistically, manufacturers should plan for approximately 4 to 5 months from test license application to MD5 license grant.

Government Fees and Costs

• MD5 License Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs include:

• Testing fees at government-approved labs (varies by test scope)
• Notified body audit fees (typically INR 50,000–100,000 depending on auditor)
• Consultancy and document preparation charges if outsourced

Common Challenges and Solutions

• Delayed Test Reports: Coordinate early with approved labs and submit samples promptly to avoid bottlenecks.
• Incomplete Documentation: Use detailed checklists and professional templates for Device and Plant Master Files.
• Audit Non-Compliance: Conduct internal pre-audits to ensure readiness; address all QMS gaps before notified body visits.
• Query Delays: Respond promptly and clearly to queries raised by CDSCO to avoid processing delays.

Expert Consultation and Support

Our 25+ years of expertise in CDSCO licensing enables us to guide manufacturers through every step—from preparing detailed Device Master Files to coordinating audits and test labs. We help clients navigate regulatory nuances specific to surgical apparel, minimizing rework and accelerating approvals.

For in-depth assistance, refer to our guides on MD5 License and Import License.

Getting Started with Your CDSCO License Application for Surgical Apparel

To initiate your CDSCO licensing process:

1. Evaluate your product classification: Confirm Surgical Apparel as a Class A device.
2. Register on the CDSCO MD Online Portal: Create your organizational account to begin applications.
3. Prepare preliminary documents: Gather company constitution, premises proof, and technical staff details.
4. Apply for Test License (MD13): Begin with this to legally manufacture test units.
5. Coordinate product testing: Schedule your samples with a government-approved lab early.
6. Compile required documentation: Use expert templates for Device Master File, Plant Master File, and Risk Management.
7. Plan for the audit: Engage a notified body from the CDSCO list well in advance to schedule your facility inspection.
8. Submit MD5 Application (Form MD3): After test license and testing completion, apply for the manufacturing license.

By following these structured steps and aligning with regulatory timelines, you can confidently bring your surgical apparel to the Indian market with full CDSCO compliance.

For personalized support, contact our regulatory consultancy team to streamline your CDSCO licensing journey.