CDSCO License for Non-latex medical examination glove

Comprehensive Guide to CDSCO Licensing for Non-latex Medical Examination Gloves (Class A)

As specialists with over 25 years of experience in medical device regulatory affairs, we have successfully assisted 500+ manufacturers in navigating the complexities of obtaining CDSCO licenses in India. This guide focuses on the Non-latex Medical Examination Glove, a Class A device used extensively as Personal Protective Equipment (PPE) to prevent cross-infection during medical examinations.

Understanding the Device and Its Regulatory Importance

Non-latex medical examination gloves are manufactured from synthetic materials to protect both patient and healthcare worker from contamination during routine examinations and handling of potentially infectious materials. Given the critical role these gloves play in infection control, regulatory compliance is essential to ensure safety, quality, and market access in India.

The device falls under Risk Class A as per the CDSCO classification, which corresponds to low-risk medical devices requiring a state-level license known as the MD5 license.

CDSCO Regulatory Framework for Non-latex Medical Examination Gloves

The Central Drugs Standard Control Organisation (CDSCO) governs the import and manufacture of medical devices in India. The regulatory framework mandates that manufacturers of Class A devices obtain an MD5 license issued by the State Licensing Authority. This ensures compliance with the Medical Device Rules, 2017, and adherence to quality and safety standards.

The specific regulatory notification applicable to this device is File No. 29/Misc./03/2020-DC (186) dated 13.9.2021.

Risk Classification and License Requirements

Device: Non-latex Medical Examination Glove
Risk Class: A (Low Risk)
License Type: MD5 Manufacturing License (State Authority)

Class A devices require submission of a test license, product testing, documentation, and audit by a notified body before license issuance.

Manufacturing License Process (MD5) for Class A Devices

The MD5 license process involves several key steps:

Test License Application (Form MD13): Before full license application, a test license is required to manufacture samples for testing.
Product Testing: Conducted at CDSCO-approved government laboratories to verify compliance with Indian standards.
Document Preparation: Compilation of all required documentation including Device Master File and Plant Master File.
License Application (Form MD3): Submit the MD5 application through the CDSCO MD Online Portal.
Audit: Inspection and audit by a notified body listed on the Notified Bodies List.
Query Resolution: Address any observations or queries raised by the licensing authority or notified body.
License Grant (Form MD5): Upon successful audit and documentation review, the MD5 license is granted.

Manufacturing License Documents Required

For Non-latex Medical Examination Gloves, the following documentation is mandatory:

Company Constitution Documents: Certificate of Incorporation, Memorandum & Articles of Association.
Proof of Ownership or Lease of Manufacturing Premises.
Technical Staff Qualifications: Details of personnel responsible for manufacturing and quality control.
No Objection Certificates: Fire safety and pollution control certificates.
Device Master File (DMF): Detailed technical specifications and manufacturing details. Refer to our comprehensive Device Master File guide.
Plant Master File (PMF): Description of manufacturing facility and quality management system. Learn how to create a PMF here.
Essential Principles Checklist: Declaration of conformity to safety and performance requirements.
Risk Management File: Hazard analysis and mitigation strategies based on ISO 14971 principles. For detailed guidance, see Risk Management.
Test Reports: From CDSCO-approved laboratories. Check the list of Testing Laboratories.
Labels and Instructions for Use (IFU): Sample labels and user manuals compliant with regulatory standards.
Quality Management System (QMS) Documents: Usually ISO 13485:2016 certification and associated procedures.

Import License Process (MD15) for Non-latex Medical Examination Gloves

While this guide focuses on manufacturing licenses, importers need to obtain an MD15 import license from the Central Licensing Authority. The MD15 process generally takes 5-6 months and requires:

Manufacturing license from the country of origin
Free Sale Certificate
ISO 13485:2016 certification
CE Certificate or equivalent
Device Master File and Plant Master File
Wholesale license in India
Company constitution documents

For detailed import process insights, please refer to our Import License Guide.

Timeline and Processing Duration

For Class A devices like non-latex examination gloves, the entire MD5 license process typically spans 3 to 4 months, broken down as follows:

Test license (Form MD13) approval: 1.5 to 2 months
Product testing at CDSCO-approved labs: 2 to 3 weeks
Document preparation and submission: 2 to 3 weeks
Audit by notified body: 3 to 4 weeks
Query resolution and license grant: 2 to 3 weeks

Government Fees and Costs

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

Additional costs may include:

Testing laboratory fees (varies by lab and test scope)
Notified body audit fees
Consultancy and document preparation fees (optional but recommended)

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Pre-schedule testing with CDSCO-approved labs and ensure samples meet submission criteria to avoid retesting.

Challenge 2: Incomplete Documentation

Solution: Use checklists and expert consultation to prepare comprehensive Device and Plant Master Files.

Challenge 3: Audit Non-compliance

Solution: Conduct internal audits and gap analysis prior to notified body inspection.

Challenge 4: Query Resolution Delays

Solution: Respond promptly and thoroughly to all queries with supporting evidence.

Expert Consultation and Support

With over 25 years of experience and a portfolio of 500+ successful CDSCO license applications, our team provides:

End-to-end license application management
Assistance with document preparation including DMF and PMF
Coordination with CDSCO laboratories and notified bodies
Training on regulatory requirements and QMS implementation

Getting Started with Your CDSCO License Application

To initiate your MD5 license application for non-latex medical examination gloves:

Assess Your Compliance Status: Review your manufacturing facility, QMS, and product conformity.
Prepare Documentation: Utilize our guides for DMF and PMF preparation.
Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
Conduct Product Testing: Coordinate with approved labs early to avoid bottlenecks.
Submit Full Application: Once testing is complete, submit your MD5 license application (Form MD3) online.
Schedule Audit: Arrange for inspection with a notified body.
Engage with Regulatory Consultants: For expert assistance, leverage experienced consultants to facilitate smooth processing.

Embarking on the CDSCO licensing journey for your non-latex medical examination gloves can seem complex, but with structured planning and expert support, market entry becomes efficient and compliant. Reach out to our team for personalized consultation to streamline your regulatory pathway.

CDSCO License for Non-latex medical examination glove

Medical Device Information

Important Notice for Class A Devices

Intended Use