CDSCO License for Latex surgical glove

Comprehensive Guide to CDSCO Licensing for Latex Surgical Gloves (Class B Medical Device)

Latex surgical gloves, a vital component of personal protective equipment (PPE), play a critical role in safeguarding both patients and healthcare providers from cross infections during medical or dental surgical procedures. Classified as a Class B medical device under the CDSCO regulatory framework, these gloves demand stringent compliance with Indian regulations to ensure safety, efficacy, and market access.

With over 25 years of experience and having assisted more than 500 companies in securing CDSCO approvals, we provide you with a detailed roadmap for obtaining your manufacturing or import license for latex surgical gloves in India.

CDSCO Regulatory Framework for Latex Surgical Gloves

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Latex surgical gloves are categorized under Class B devices, which are considered low to moderate risk. The regulatory pathway involves obtaining an MD5 manufacturing license (for domestic manufacturers) or an MD15 import license (for importers).

The relevant notification for latex surgical gloves is File No. 29/Misc./03/2020-DC (186), dated 13.9.2021, which officially classifies these gloves as Class B devices under PPE category.

Risk Classification and License Requirements

• Device: Latex surgical glove
• Risk Class: Class B (low to moderate risk)
• Regulatory License: MD5 Manufacturing License (Form MD3) for manufacturers
• Authority: State Licensing Authority
• Process Duration: Approximately 3-4 months

For importers, the MD15 license is mandatory, governed by the Central Licensing Authority, with a slightly longer processing time.

For details on medical device classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Latex Surgical Gloves

The MD5 license process is specific to Class A and B device manufacturers. Below is a stepwise approach:

1. Obtain Test License (Form MD13): Initiate by applying for a test license, which typically takes 1.5 to 2 months. This allows you to manufacture a limited quantity of gloves for testing purposes.

2. Testing in Government-Approved Labs: Your gloves must undergo mandatory testing in CDSCO-recognized laboratories to verify compliance with Indian standards. A list of approved testing laboratories is available.

3. Document Preparation: Consolidate all necessary documentation, including technical files and quality management system (QMS) documents.

4. Apply for MD5 License (Form MD3): Submit your formal manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will conduct an onsite audit of your manufacturing facility. You can verify the list of notified bodies authorized for MD5 audits.

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

7. Grant of License: Upon successful audit and documentation review, the MD5 license will be issued on Form MD5, enabling commercial manufacturing and sale.

For an in-depth overview, see our MD5 License Guide.

Manufacturing License Documents Required for Latex Surgical Gloves

To ensure a smooth process, prepare the following documents meticulously:

• Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent
• Proof of Premises Ownership or Lease
• Technical Staff Qualifications: Details and CVs of manufacturing and quality management personnel
• Fire and Pollution NOCs: Clearance certificates from local authorities
• Device Master File (DMF): Comprehensive technical dossier covering design, ingredients, manufacturing process, and testing. Our Device Master File Guide offers detailed insights.
• Plant Master File (PMF): Description of manufacturing facilities, equipment, utilities. Learn how to prepare PMF here.
• Essential Principles Checklist: Compliance with Indian medical device essential principles
• Risk Management File: Documented risk analysis and mitigation plans per ISO 14971 standards. Read more on Risk Management.
• Test Reports: From government-approved laboratories verifying compliance with relevant standards (e.g., ISO 11193-1 for surgical gloves)
• Labels and Instructions for Use (IFU): Draft labels and IFU compliant with CDSCO guidelines
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related procedures

Import License Process (MD15) for Latex Surgical Gloves

Importers must obtain the MD15 license from the Central Licensing Authority. The process includes:

1. Document Preparation: Compile required documents, including your manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE certificate, Device Master File, Plant Master File, and wholesale license.

2. Application Submission: File Form MD14 for import license on the CDSCO MD Online Portal.

3. Departmental Review and Queries: Respond promptly to any clarifications.

4. License Grant: Upon satisfaction, the MD15 license is issued.

The import license process typically takes 5-6 months. For a comprehensive guide, visit our Import License Guide.

Import License Documents Required

• Manufacturing License of foreign manufacturer
• Free Sale Certificate from country of origin
• ISO 13485:2016 certification
• CE Certificate (if available)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration

Planning ahead is essential. For example, manufacturers should factor in 1.5 to 2 months for product testing, followed by 1.5 to 2 months for document preparation and audit scheduling.

Government Fees and Costs

• MD5 License: Application fee of ₹5,000 plus ₹500 per product.
• MD15 Import License: Fees vary by device class; for Class B devices like latex gloves, approximately $2,000 per site plus$1,000 per product.

Budgeting for these fees upfront can reduce delays due to payment-related issues.

Common Challenges and Solutions

• Delayed Testing Results: Schedule testing early and choose CDSCO-approved labs carefully. Consult the Testing Laboratories list for options.

• Incomplete Documentation: Use checklists and templates, and consider professional help to ensure completeness.

• Audit Non-Compliance: Conduct internal mock audits to prepare your facility and staff.

• Query Resolution Delays: Respond promptly and thoroughly to CDSCO or notified body queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for companies new to the Indian market. We offer tailored consulting services to assist you in:

• Preparing and reviewing technical files and master files
• Coordinating with notified bodies and testing labs
• Managing audit schedules and compliance
• Addressing regulatory queries efficiently

Our hands-on approach has helped over 500 companies successfully obtain their licenses on time.

Getting Started with Your CDSCO License Application for Latex Surgical Gloves

1. Assess your device classification and intended license type (MD5 for manufacturing, MD15 for import).

2. Initiate the Test License (MD13) process early if manufacturing domestically.

3. Identify and engage with CDSCO-approved testing laboratories and notified bodies.

4. Compile your Device Master File and Plant Master File meticulously.

5. Register and submit your application on the CDSCO MD Online Portal with complete documents and fees.

6. Prepare your facility and team for the audit process.

7. Stay responsive to CDSCO and notified body communications to expedite approval.

By following these actionable steps and leveraging expert support, you can efficiently navigate the regulatory landscape and bring your latex surgical gloves to the Indian market with full compliance and confidence.