CDSCO License for Teething device, fluid- filled

Comprehensive Guide to CDSCO Licensing for Fluid-Filled Teething Devices (Class B)

When it comes to pediatric medical devices like fluid-filled teething devices, regulatory compliance is paramount to ensure safety and efficacy for infants and adults alike. As a circular or cylindrical device filled with fluid intended to soothe gums during teething, this device falls under the Class B risk category according to CDSCO regulations. With over 25 years of experience and having supported 500+ companies navigate CDSCO licensing successfully, we provide you with a detailed, actionable roadmap to secure your manufacturing or import license for this specific device.

Understanding the CDSCO Regulatory Framework for Fluid-Filled Teething Devices

The Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing in India. As per the notification file number 29/MiscJ03/2020-DC (150) dated 23.8.2021, fluid-filled teething devices are regulated under the Pediatrics and Neonatology category. Since these devices are reusable and come into direct contact with mucous membranes, their risk classification is Class B, necessitating careful adherence to regulatory pathways.

Risk Classification and License Requirements for Class B Devices

Under CDSCO's risk-based classification, Class B devices require a manufacturing license known as MD5, issued by the State Licensing Authority. Importers of Class B devices apply for an MD15 license from the Central Licensing Authority. The MD5 license process involves obtaining a test license, product testing at CDSCO-approved laboratories, documentation, and an audit by a notified body. Our guidance below focuses on manufacturing, but we also cover import procedures.

Step-by-Step Manufacturing License Process for Fluid-Filled Teething Devices (MD5)

1. Apply for Test License (Form MD13):
   • Duration: Approximately 1.5 to 2 months
   • Purpose: To legally conduct product testing and gather necessary test reports
2. Product Testing:
   • Conduct testing at CDSCO-recognized labs to ensure compliance with Indian standards.
   • Refer to the Testing Laboratories list for approved facilities.
3. Prepare Comprehensive Documentation:
   • Device Master File (DMF), Plant Master File (PMF)
   • Quality Management System (QMS) documents
   • Risk Management File specifically addressing fluid-filled teething device hazards
   • Essential Principles Checklist, labels, Instructions for Use (IFU)
4. Submit MD5 License Application (Form MD3):
   • Via the CDSCO MD Online Portal
5. Audit by Notified Body:
   • Select an auditor from the list of notified bodies
   • Audit focuses on manufacturing premises, QMS, and compliance
6. Address Queries and Deficiencies:
   • Expect back-and-forth communication to clarify documents or processes
7. Grant of MD5 License:
   • Upon satisfactory completion of audits and document review

Essential Documents Required for MD5 License Application

• Company Constitution: Incorporation certificates, partnership deed, etc.
• Proof of Premises Ownership or Lease Agreement: Registered property documents
• Technical Staff Details: Qualifications and experience
• Fire NOC and Pollution NOC: Obtain from local authorities
• Device Master File (DMF): Detailed device description, design, manufacturing process (Learn more in our Device Master File guide)
• Plant Master File (PMF): Facility layout, equipment details (see our Plant Master File guide)
• Essential Principles Checklist: Compliance with safety and performance requirements
• Risk Management File: Addressing potential hazards related to fluid-filled design (Risk Management insights)
• Test Reports: From CDSCO-approved labs
• Labels and IFU: Clearly explaining intended use, warnings, cleaning instructions
• Quality Management System Documents: ISO 13485 certification and internal procedures

Import License Process for Fluid-Filled Teething Devices (MD15)

For importers, the MD15 license from the Central Licensing Authority is mandatory. Unlike the manufacturing license, no test license is required upfront. The process is as follows:

1. Prepare Documentation:
   • Manufacturing license from the country of origin
   • Free Sale Certificate
   • ISO 13485:2016 and CE Certificate
   • Device and Plant Master Files
   • Wholesale license
   • Company Constitution
2. Submit Application (Form MD14) on the CDSCO MD Online Portal
3. Respond to Queries from CDSCO
4. Grant of Import License (MD15)

Timeline and Processing Duration

• MD5 Manufacturing License: 3-4 months total
  • Test license: 1.5-2 months
  • Testing and audit: ~1 month
  • Query resolution and license grant: 0.5-1 month
• MD15 Import License: 5-6 months due to central authority processing and document verification

Government Fees and Costs

• MD5 License:
  • Application fee: Rs 5,000
  • Per product fee: Rs 500
• MD15 Import License:
  • Class B devices: Rs 2,000 per site
  • Rs 1,000 per product

Budgeting for testing, notified body audits, and document preparation is essential; these can range from Rs 50,000 to Rs 2,00,000 depending on complexity.

Common Challenges and Practical Solutions

• Delay in Test Reports: Plan tests early and choose labs with proven turnaround times.
• Incomplete Documentation: Use checklists and consult experts to ensure DMF and PMF completeness.
• Audit Non-Compliance: Conduct internal mock audits ahead of the notified body visit.
• Query Management: Respond promptly and with detailed evidence to avoid license delays.

Expert Consultation and Support

Given the complexity of regulatory requirements for fluid-filled teething devices, partnering with experienced regulatory consultants can significantly streamline the process. We have supported over 500 companies in obtaining timely approvals, helping with document preparation, audit readiness, and liaison with CDSCO officials.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class B status and regulatory pathway.
2. Register on the CDSCO MD Online Portal: Begin your application process.
3. Engage with a CDSCO-Recognized Testing Laboratory: Schedule product testing early.
4. Prepare Your Documentation: Utilize our detailed guides on DMF, PMF, and risk management.
5. Plan for Audit: Select a notified body and schedule the audit.
6. Budget Accordingly: Allocate funds for fees, testing, and consultancy.

Starting with a clear roadmap and professional guidance ensures your fluid-filled teething device enters the Indian market compliantly and efficiently. Reach out to our expert team to tailor a step-by-step plan specific to your manufacturing or import scenario.