CDSCO License for Non-powdered surgeon's glove.

Introduction to Non-Powdered Surgeon's Gloves and CDSCO Licensing

Non-powdered surgeon's gloves are essential medical devices designed to protect surgical wounds from contamination by acting as a barrier on the hands of operating room personnel. Categorized under Dermatological & Plastic Surgery devices, these gloves fall under Class A—considered low-risk devices—according to the CDSCO classification.

Given their critical role in infection control, regulatory compliance for manufacturing and importing these devices in India is mandatory. The Central Drugs Standard Control Organization (CDSCO) regulates these devices to ensure safety, quality, and efficacy. As regulatory consultants with over 25 years of experience and having assisted 500+ companies, we provide detailed insights into obtaining the required licenses efficiently.

CDSCO Regulatory Framework for Non-Powdered Surgeon's Gloves

The regulatory framework for medical devices in India aligns with the Medical Device Rules, 2017 (amended 2020). For non-powdered surgeon's gloves, the relevant notification is 29/Misc./03/2020-DC (147), dated 26.7.2021, which officially classifies these gloves as Class A devices.

Manufacturing and import of these gloves require compliance with CDSCO licensing, specifically the MD5 manufacturing license for Class A devices and the MD15 import license for importers.

Risk Classification and License Requirements

Non-powdered surgeon's gloves are classified as Class A devices due to their low risk to patients and users. This classification determines the licensing pathway:

• Manufacturing License: MD5 License (Application Form MD3), issued by the State Licensing Authority.
• Import License: MD15 License (Application Form MD14), issued by the Central Licensing Authority.

It is crucial to understand these distinctions early to streamline the application process.

Manufacturing License Process (MD5)

For manufacturing non-powdered surgeon's gloves in India, the MD5 license process involves the following key steps:

1. Obtain a Test License (Form MD13): Before full manufacturing approval, a test license is mandatory. This allows initial production for testing purposes.

2. Product Testing: Conduct product testing at CDSCO-approved laboratories to validate compliance with Indian standards. Refer to the official Testing Laboratories list.

3. Document Preparation: Compile required documents including Device Master File, Plant Master File, Quality Management System (QMS) documents, and others.

4. Submission of MD5 Application (Form MD3): Submit the complete application through the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is performed by a notified body listed here to verify compliance with manufacturing practices.

6. Query Resolution: Respond to any queries raised by the licensing authority or notified body.

7. Grant of MD5 License: Upon satisfactory review, the State Licensing Authority issues the manufacturing license.

For a detailed guide, our MD5 License Guide provides step-by-step assistance.

Manufacturing License Documents Required

To successfully apply for the MD5 license for non-powdered surgeon's gloves, the following documents must be prepared:

• Company Constitution (Incorporation Certificate, MOA/ AOA)
• Proof of Ownership or Tenancy of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications, manufacturing process, and quality controls. Refer to our comprehensive Device Master File guide
• Plant Master File (PMF) describing manufacturing facilities and equipment. Learn more at Plant Master File Guide
• Essential Principles Checklist as per Medical Device Rules
• Risk Management File documenting hazard analysis and mitigation strategies. Explore best practices in Risk Management
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU) in compliance with regulatory standards
• Quality Management System (QMS) Documents aligned with ISO 13485 requirements

Meticulous preparation of these documents significantly reduces back-and-forth with CDSCO.

Import License Process (MD15)

For companies looking to import non-powdered surgeon's gloves into India, obtaining an MD15 import license is mandatory. The process includes:

1. Document Preparation: Gather all necessary certificates including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), and Device/Plant Master Files.

2. Application Submission: File the application using Form MD14 through the CDSCO MD Online Portal.

3. Query Resolution: Address any clarifications requested by CDSCO.

4. License Issuance: Upon successful evaluation, the Central Licensing Authority grants the MD15 license.

Our detailed Import License Guide covers all nuances.

Import License Documents Required

The following are essential for the MD15 application:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or Equivalent
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File (DMF)
• Plant Master File (PMF)
• Wholesale Drug License or equivalent distribution license
• Company Constitution documents

Thorough documentation ensures a smooth review process.

Timeline and Processing Duration

For non-powdered surgeon's gloves (Class A), typical timelines are:

• MD5 Manufacturing License: Approximately 3-4 months total.

  • Test License (MD13): 1.5-2 months
  • Product Testing: 2-3 weeks
  • Document Preparation & Submission: 2-3 weeks
  • Audit & Query Resolution: 1-1.5 months

• MD15 Import License: Approximately 5-6 months, as it requires thorough review by the Central Licensing Authority.

Understanding these timelines helps in planning market entry and production schedules effectively.

Government Fees and Costs

For MD5 manufacturing license of Class A devices such as non-powdered surgeon's gloves:

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

Additional costs include product testing fees at CDSCO-approved labs and notified body audit fees.

For MD15 import license fees vary by class but for Class A devices approximate fees are:

• Site Fee: $1000
• Product Fee: $50 per product

Budgeting for these expenses upfront avoids delays due to incomplete payments.

Common Challenges and Solutions

Challenge: Delays in product testing due to lab backlogs.

Solution: Engage early with CDSCO-approved testing laboratories and submit samples promptly. Maintaining a buffer period in the project timeline is advisable.

Challenge: Incomplete or inconsistent documentation causing repeated queries.

Solution: Employ a checklist-driven approach to document preparation. Utilizing templates for Device Master File and Plant Master File can ensure completeness.

Challenge: Audit findings requiring corrective actions.

Solution: Conduct internal mock audits prior to notified body inspection to identify gaps and implement corrective measures.

Our extensive experience enables us to preempt such hurdles and guide clients to successful license acquisition.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time applicants. Our team has successfully guided over 500 manufacturers and importers through the entire process. We offer:

• Comprehensive gap assessments
• Document preparation support
• Coordination with notified bodies and testing labs
• Audit readiness and post-audit support
• Application submission and follow-up through the CDSCO MD Online Portal

Engage with us early to leverage our expertise and reduce your time to market.

Getting Started with Your CDSCO License Application

If you are manufacturing or importing non-powdered surgeon's gloves, here are practical next steps:

1. Determine Your Licensing Needs: Confirm if you require an MD5 manufacturing license or MD15 import license based on your business model.

2. Gather Documentation: Begin compiling your Device Master File, Plant Master File, and other supporting documents as outlined above.

3. Apply for Test License (for manufacturing): Submit Form MD13 through the CDSCO MD Online Portal to initiate the test license process.

4. Schedule Product Testing: Coordinate with CDSCO-approved laboratories early.

5. Prepare for Audit: Identify a notified body from the list of notified bodies and schedule your audit.

6. Consult with Regulatory Experts: Engage experienced consultants to review your application and documentation.

7. Submit Your Application: Upload and track your license application via the CDSCO MD Online Portal.

Following these steps methodically maximizes your chances of a smooth and timely license grant.

For personalized assistance and in-depth support, connect with our regulatory consulting team today and leverage our 25+ years of experience in CDSCO licensing for medical devices.