CDSCO License for Non-latex surgical glove

Comprehensive Guide to CDSCO Licensing for Non-Latex Surgical Gloves (Class B)

Non-latex surgical gloves are essential personal protective equipment (PPE) designed to protect both patients and healthcare workers from cross-infection during medical and dental surgeries. Manufactured from synthetic materials, these gloves serve as a critical barrier in clinical environments. Given their medical application and risk profile, obtaining a CDSCO license is mandatory for manufacturing or importing non-latex surgical gloves into India.

With over 25 years of experience and having assisted more than 500 companies in acquiring CDSCO approvals, we provide a detailed roadmap specific to Class B medical devices like non-latex surgical gloves, ensuring your regulatory journey is efficient and compliant.

CDSCO Regulatory Framework for Non-Latex Surgical Gloves

India’s Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. Non-latex surgical gloves fall under the Personal Protective Equipment category and are classified as Class B devices due to moderate risk levels.

The regulatory framework mandates obtaining a manufacturing license (MD5) for domestic production or an import license (MD15) for foreign manufacturers and importers. Compliance with essential principles, quality management systems, and product testing is strictly enforced to safeguard public health.

Risk Classification and License Requirements for Class B Devices

Per CDSCO’s classification, Class B devices are medium-risk medical devices. Non-latex surgical gloves fall squarely in this class, requiring the following:

• Manufacturing License: MD5 License granted by the State Licensing Authority
• Import License: MD15 License granted by Central Licensing Authority

The MD5 license process includes product testing, audit by a notified body, and submission of detailed technical and quality documentation. Importers must meet documentation and registration requirements and pay applicable fees.

Learn more about Medical Device Classification for clarity.

Manufacturing License Process for Non-Latex Surgical Gloves (MD5)

Manufacturing non-latex surgical gloves requires obtaining an MD5 license under Form MD3. The stepwise process is:

1. Test License (Form MD13): Apply for a test license to manufacture and test the product legally. This takes approximately 1.5-2 months.
2. Product Testing: Conduct mandatory tests at CDSCO-approved laboratories. Find the list of Testing Laboratories here.
3. Document Preparation: Compile all required documents including Device Master File, Plant Master File, risk management, and quality system documentation.
4. Application Submission: File application on the CDSCO MD Online Portal using Form MD3.
5. Audit: A notified body (from the CDSCO List of Notified Bodies) will audit the manufacturing facility and documentation.
6. Query Resolution: Address any queries raised by the licensing authority or notified body.
7. Grant of License: Upon successful review and audit, the MD5 license is granted on Form MD5.

The entire process typically spans 3-4 months from test license application to license grant.

Manufacturing License Documents Required for Non-Latex Surgical Gloves

Applicants must provide comprehensive documentation to demonstrate compliance:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Proof of Technical Staff
• Fire and Pollution NOCs
• Device Master File detailing product specifications and design (Device Master File Guide)
• Plant Master File outlining manufacturing processes (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with MDR 2017
• Risk Management File specific to non-latex surgical gloves (Risk Management)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Ensuring documentation accuracy reduces back-and-forth and accelerates approval.

Import License Process for Non-Latex Surgical Gloves (MD15)

For importers, the MD15 license is mandatory and issued by the Central Licensing Authority. The process includes:

1. Document Preparation: Compile manufacturing license of overseas manufacturer, Free Sale Certificate, ISO 13485:2016, CE certificate, Device and Plant Master Files, wholesale license, and company constitution.
2. Application Submission: File Form MD14 on the CDSCO MD Online Portal.
3. Review and Queries: Address any departmental queries promptly.
4. Grant of License: License is granted on Form MD15.

The import license process typically takes 5-6 months.

Import License Documents Required

Key documents to prepare include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License issued by Indian authority
• Company Constitution and Importer’s PAN

Fees vary based on risk class; Class B devices incur higher costs than Class A.

Timeline and Processing Duration

Proactive preparation and adherence to guidelines can shave weeks off these timelines.

Government Fees and Costs

For a Class B non-latex surgical glove:

• MD5 License:

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

• MD15 Import License:

  • Site Fee: $2,000
  • Per Product Fee: $1,000

Additional costs include testing fees at approved labs and audit charges by notified bodies.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-conformance with essential principles.

Solution: Utilize our detailed MD5 License Guide to ensure all documents meet CDSCO standards. Pre-audit internal checks can catch issues early.

Challenge: Difficulty in coordinating product testing and audits.

Solution: Engage with notified bodies early and schedule testing at CDSCO-recognized labs listed here.

Challenge: Handling queries from CDSCO authorities.

Solution: Maintain transparent communication and respond with precise, supported information swiftly.

Expert Consultation and Support

Navigating CDSCO regulations for Class B devices like non-latex surgical gloves can be complex. Our 25+ years of regulatory consulting experience means we understand the nuances and can guide you through every step—from document preparation and testing coordination to audit readiness and application submission.

We offer tailored support to streamline your licensing process, mitigate risks, and ensure timely approval.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device as Class B using the Medical Device Classification resources.
2. Prepare Your Documents: Begin compiling all necessary technical, quality, and legal documents.
3. Apply for Test License: Submit Form MD13 on the CDSCO MD Online Portal to initiate the manufacturing and testing phase.
4. Schedule Testing and Audits: Coordinate with notified bodies and testing laboratories early to avoid bottlenecks.
5. Submit Manufacturing License Application: After successful testing, file Form MD3 for the MD5 license.
6. Engage with Authorities: Promptly respond to any queries and prepare for audits.

For importers, focus on gathering import-specific documents and filing Form MD14 for the MD15 license.

By following these practical steps and leveraging expert guidance, manufacturers and importers of non-latex surgical gloves can confidently enter the Indian market with full regulatory compliance.