CDSCO License for Teething device, non- fluid-filled

Introduction to Teething Devices and Regulatory Importance

Teething devices, particularly non-fluid-filled types designed for soothing infants' or adults' gums, are essential pediatric medical products that require strict regulatory compliance before entering the Indian market. Given their direct contact with vulnerable users, such as infants, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures safety, quality, and efficacy. Our 25+ years’ experience helping over 500 companies obtain CDSCO licenses uniquely positions us to guide manufacturers and importers through this process efficiently.

CDSCO Regulatory Framework for Non-Fluid-Filled Teething Devices

Under CDSCO regulation, teething devices fall under the pediatrics and neonatology category. The device in question—a circular or cylindrical, reusable, non-fluid-filled teether—is classified as a Class A medical device according to the Indian Medical Device Rules, 2017. This classification mandates compliance primarily through the State Licensing Authority using the MD5 license pathway.

Risk Classification and License Requirements for Class A Devices

Class A devices, deemed low-risk, include non-invasive, non-fluid-filled teething devices. The regulatory framework requires manufacturers to obtain an MD5 license (Manufacturing License for Class A devices) before manufacture and sale in India. The MD5 license process involves obtaining a test license (Form MD13), product testing, audit by notified bodies, and submission of comprehensive documentation.

Manufacturing License Process (MD5) for Teething Devices

The entire MD5 manufacturing license process typically spans 3 to 4 months and includes these sequential steps:

1. Test License (Form MD13): Initial application to manufacture and test the product in a lab.
2. Product Testing: Testing in CDSCO-approved laboratories to confirm compliance with standards.
3. Document Preparation: Compilation of Device Master File, Plant Master File, risk management, and quality management system documents.
4. Application Submission: Filing Form MD3 via the CDSCO MD Online Portal for the MD5 license.
5. Audit: Inspection and audit by a listed Notified Body to verify compliance.
6. Query Resolution: Responding to any queries from the CDSCO or notified body.
7. License Grant: Issuance of the MD5 license on Form MD5.

Manufacturing License Documents Required for Teething Device

Manufacturers must prepare and submit the following documents:

• Company constitution and registration proof
• Proof of ownership or lawful possession of manufacturing premises
• Technical staff qualifications and experience records
• Fire safety and pollution control clearances (Fire NOC, Pollution NOC)
• Device Master File detailing design, materials, and specifications (see our comprehensive Device Master File guide)
• Plant Master File illustrating manufacturing processes and quality controls (detailed in our Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File documenting hazard identification and mitigation strategies (learn more in our Risk Management resource)
• Test reports from CDSCO-approved laboratories (list available here)
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process (MD15) for Teething Devices

For importers, an MD15 license granted by the Central Licensing Authority is mandatory. This process takes approximately 5 to 6 months and involves:

• Preparation of documents including manufacturing license, free sale certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files
• Submission of Form MD14 via the CDSCO portal
• Resolution of any CDSCO queries
• Final grant of MD15 license

Note that test licenses are not required for import licensing.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate issued by the regulatory authority of exporting country
• ISO 13485:2016 Quality Management certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale drug license or equivalent distribution license in India
• Company constitution and registration

Timeline and Processing Duration

For import licenses (MD15), the overall timeline is typically 5 to 6 months.

Government Fees and Costs

For Class A teething devices, the CDSCO fee structure is as follows:

• MD5 License Application Fee: Rs. 5,000 per application
• Per Product Fee: Rs. 500 per product

Additional costs include:

• Testing fees charged by government-approved laboratories
• Notified body audit fees (variable, depending on notified body selected)
• Consultancy or documentation preparation fees if professional assistance is engaged

Common Challenges and Solutions

Challenges:

• Incomplete or inconsistent documentation leading to delays
• Difficulty navigating audit requirements by notified bodies
• Delays in laboratory testing due to backlog
• Responding effectively to CDSCO queries

Solutions:

• Early and thorough preparation of all documents, using checklists and expert templates
• Selecting notified bodies with availability and expertise in Class A devices
• Scheduling lab tests in advance and understanding test protocols
• Engaging experienced regulatory consultants to draft precise responses and ensure compliance

Expert Consultation and Support

With over 25 years of deep expertise and having facilitated licensing for 500+ medical device companies, we provide tailored support for teething device manufacturers and importers. Our services include:

• Gap analysis of existing documentation
• Preparation and review of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• End-to-end application filing and query management
• Training on regulatory compliance and post-license obligations

Our proven track record enables smoother approvals and faster market entry.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm Class A status using resources like our Medical Device Classification guide.
2. Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the platform for application submissions.
3. Initiate Test License (MD13) application: Begin by applying for the test license to legally manufacture and test your teething device.
4. Engage a notified body: Select and coordinate with a CDSCO-recognized notified body for the mandatory audit.
5. Prepare comprehensive documentation: Utilize our Device and Plant Master File guides to compile robust technical files.
6. Schedule product testing: Book slots at CDSCO-approved labs early to avoid delays.
7. Submit MD5 license application (Form MD3): Once testing and documentation are ready, apply for the manufacturing license.
8. Respond promptly to queries: Ensure timely communication with CDSCO and notified bodies to prevent processing delays.

For detailed assistance, visit the CDSCO MD Online Portal and explore our expert consultancy services to fast-track your regulatory journey.

Embarking on the regulatory pathway for your teething device need not be daunting. With structured planning and expert support, you can secure your CDSCO license efficiently, ensuring compliance and market readiness.