CDSCO License for Latex medical examination glove

Comprehensive Guide to CDSCO Licensing for Latex Medical Examination Gloves (Class A Device)

Latex medical examination gloves are essential personal protective equipment (PPE) used widely in healthcare settings to prevent cross-contamination between patients and healthcare providers during examinations and handling of contaminated materials. Classified as a Class A medical device under the CDSCO regulations, these gloves require a well-defined regulatory pathway to ensure safety and compliance for sale and manufacture in India.

Having supported over 500 companies in successfully navigating CDSCO licensing, we understand the nuances and critical requirements for Class A devices like latex gloves. This guide offers detailed insights into the regulatory framework, step-by-step licensing processes, typical timelines, costs involved, and practical tips to help manufacturers and importers enter the Indian market smoothly.

CDSCO Regulatory Framework for Latex Medical Examination Gloves

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India to ensure quality, safety, and effectiveness. Latex medical examination gloves fall under the category of Personal Protective Equipment (PPE) and are notified under File No. 29/Misc./03/2020-DC (186), dated 13.9.2021.

As a Class A medical device (low risk), the primary regulatory requirement is to obtain the MD5 manufacturing license if you intend to manufacture in India. For importers, the MD15 import license is mandatory.

You must comply with the Medical Device Rules, 2017 and adhere to essential principles such as product quality, labeling, and documentation.

Risk Classification and License Requirements for Latex Gloves

• Device Risk Class: Class A (Low Risk)
• Regulatory Authority: State Licensing Authority
• License Type: MD5 Manufacturing License
• Application Form: MD3 for manufacturing; MD13 for test license
• Timeline: 3-4 months (inclusive of test license, testing, audit)
• Government Fees: Rs. 5,000 per application + Rs. 500 per product

For detailed classification guidance, see the Medical Device Classification resource.

Manufacturing License Process for Latex Medical Examination Gloves (MD5 License)

1. Apply for Test License (Form MD13):

   • Initiate by applying for a test license to legally manufacture and test the product.
   • Timeline: Approximately 1.5-2 months.

2. Product Testing:

   • Get your latex gloves tested at CDSCO-recognized government-approved laboratories.
   • Testing parameters typically include physical integrity, material safety, and biocompatibility.
   • Refer to the Testing Laboratories List to select an approved lab.

3. Documentation Preparation:

   • Prepare comprehensive documentation including Device Master File, Plant Master File, Quality Management System (QMS) records, risk management, and labeling.

4. Apply for Manufacturing License (Form MD3):

   • Submit your application via the CDSCO MD Online Portal.

5. Audit by Notified Body:

   • Engage a notified body for the mandatory audit of your manufacturing facility.
   • Find the list of notified bodies authorized for MD5 audits.

6. Query Resolution:

   • Address any queries or observations raised during audit or by the licensing authority promptly.

7. License Grant:

   • Upon satisfactory compliance, the State Licensing Authority issues the MD5 Manufacturing License (Form MD5).

Manufacturing License Documents Required for Latex Gloves

• Company constitution documents (e.g., incorporation certificate)
• Proof of ownership or valid lease of manufacturing premises
• Technical staff qualifications and experience details
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing product specifications and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) describing the manufacturing site and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File highlighting identified risks and mitigation measures (Risk Management)
• Test reports from approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process for Latex Medical Examination Gloves (MD15 License)

If importing latex gloves into India, an MD15 Import License from CDSCO’s Central Licensing Authority is mandatory.

1. Document Preparation:

   • Prepare all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE Certificate (if applicable), DMF, PMF, and wholesale license.

2. Application Submission:

   • Apply on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution:

   • Respond to any queries raised by CDSCO timely to avoid delays.

4. License Grant:

   • MD15 Import License is granted, typically within 5-6 months.

Import License Documents Required

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License in India
• Company constitution documents

Timeline and Processing Duration

For imports, the MD15 license process typically takes 5 to 6 months.

Government Fees and Costs for Latex Gloves License

• MD5 Manufacturing License:

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

• MD13 Test License:

  • Included in manufacturing license process costs

• MD15 Import License:

  • Class A devices: $1000 per site +$50 per product

These fees are subject to change; always verify via the official CDSCO MD Online Portal.

Common Challenges and Solutions in CDSCO Licensing for Latex Gloves

• Delays in Test Reports: To avoid delays, pre-select testing labs with proven turnaround times and maintain good communication.
• Incomplete Documentation: Use detailed checklists and pre-audit your documents against CDSCO requirements.
• Audit Non-Compliance: Conduct internal mock audits and ensure your QMS is aligned with ISO 13485 standards.
• Query Backlogs: Respond promptly and comprehensively to queries to keep the process on track.

Our experience with 500+ clients shows that proactive planning and expert consultation significantly reduce approval timelines.

Expert Consultation and Support

Navigating the regulatory landscape for medical devices in India can be complex, especially for new manufacturers or importers. Our team offers tailored support including:

• Regulatory gap analysis for your latex glove product
• Complete documentation preparation and review
• Coordination with notified bodies and testing laboratories
• End-to-end application management on the CDSCO portal
• Post-license compliance and renewals

Partnering with experienced consultants ensures your application meets all regulatory expectations with minimal rejections or delays.

Getting Started with Your CDSCO License Application for Latex Medical Examination Gloves

1. Confirm Device Classification: Verify your product as Class A and understand applicable requirements.
2. Compile Required Documents: Begin assembling your Device Master File, Plant Master File, QMS documentation, and supporting certificates.
3. Apply for Test License (MD13): Initiate the test license via the CDSCO MD Online Portal to start manufacturing and testing legally.
4. Schedule Product Testing: Engage with an approved testing laboratory early to plan sample submission and testing timelines.
5. Prepare for Audit: Select a notified body from the official list and schedule your audit.
6. Submit MD5 Application: Complete the Form MD3 application and submit it online.
7. Track Application Status: Regularly monitor and respond to CDSCO queries to avoid delays.

By following these steps diligently and leveraging expert guidance, manufacturers and importers can successfully obtain the necessary CDSCO licenses to bring high-quality latex medical examination gloves to the Indian market.

For further assistance, consider consulting our detailed guides on MD5 License and Device Master Files.

We are committed to helping you navigate the complexities of medical device regulation with confidence and efficiency, ensuring your latex medical examination gloves meet all CDSCO requirements and reach healthcare professionals safely and swiftly.