CDSCO License for Tongue-adjustment sleep apnoea treatment system
Medical Device Information
Intended Use
An assembly of devices intended for home management of obstructive sleep apnoea (OSA) by monitoring breathing parameters during sleep to detect the onset of an apnoea event and reducing pharyngeal obstruction by the tongue.
Introduction to Tongue-Adjustment Sleep Apnoea Treatment System and Regulatory Importance
The Tongue-adjustment sleep apnoea treatment system is an innovative respiratory medical device designed for home management of obstructive sleep apnoea (OSA). This device monitors breathing parameters during sleep, detects apnoea events, and reduces pharyngeal obstruction by adjusting the tongue position. Given its critical role in managing a serious sleep disorder, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing in India.
Regulatory approval ensures device safety, efficacy, and quality, protecting end-users and building manufacturer credibility. For manufacturers and importers, understanding the CDSCO licensing framework for this Class B device is essential to navigate the approval process efficiently.
CDSCO Regulatory Framework for Tongue-Adjustment Sleep Apnoea Devices
This device falls under the respiratory category and is classified as Class B according to CDSCO’s risk classification guidelines. The regulatory framework mandates obtaining a manufacturing license (MD5) through the State Licensing Authority for Class A and B devices. Importers require an import license (MD15) from the Central Licensing Authority.
The device is covered under Notification File No. 29/Misc/03/2020-DC(197) dated 6.8.2021, confirming its recognition within the Indian medical device regulatory system.
Risk Classification and License Requirements
- Risk Class: B (low-moderate risk)
- License Required: MD5 (Manufacturing License) for domestic manufacturers
- Regulatory Authority: State Licensing Authority
- Application Form: MD3 for manufacturing license
Class B devices like the tongue-adjustment sleep apnoea treatment system require a test license (MD13) before the manufacturing license application. This ensures compliance with safety and performance standards.
For further clarity on classification, manufacturers can refer to the Medical Device Classification Guide.
Manufacturing License Process (MD5) for Class B Devices
Obtaining the MD5 license involves several well-defined steps:
Test License Application (Form MD13): Apply for a test license through the CDSCO MD Online Portal. This license is mandatory before manufacturing and testing the device.
Product Testing: Submit the device to CDSCO-approved testing laboratories for mandatory performance and safety tests. Refer to the Testing Laboratories List to select an accredited lab.
Document Preparation: Compile all required documents, including Device and Plant Master Files, risk management documentation, and QMS records.
Manufacturing License Application (Form MD3): Submit the application for the MD5 license on the CDSCO portal.
Audit by Notified Body: Engage a CDSCO-recognized notified body for a thorough audit of your manufacturing facility. Use the Notified Bodies List to select the auditor.
Query Resolution: Address any queries or deficiencies raised during the audit or by CDSCO officials promptly.
License Grant: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license.
This entire process typically spans 3 to 4 months, including test license issuance, testing, audit, and final licensing.
Manufacturing License Documents Required
For your tongue-adjustment sleep apnoea treatment system, ensure the following documents are in order:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, materials, manufacturing process, and safety data. Our comprehensive Device Master File Guide can assist here.
- Plant Master File (PMF) describing the manufacturing setup, equipment, and quality control processes. Refer to our Plant Master File Guide for details.
- Essential Principles Checklist confirming compliance with Indian Medical Device Rules
- Risk Management File capturing hazard analysis and mitigation strategies. See our Risk Management Overview for best practices.
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485 certified
Import License Process (MD15) for Tongue-Adjustment Sleep Apnoea Devices
If you are an importer of this device, obtaining an MD15 import license from the Central Licensing Authority is mandatory before marketing in India. The process includes:
- Preparing requisite documentation (see next section)
- Filing the application on the CDSCO MD Online Portal
- Responding to any queries from CDSCO
- Receiving the import license (Form MD15)
The import license process for Class B devices typically takes 5 to 6 months.
Import License Documents Required
Key documents for MD15 import license include:
- Valid Manufacturing License (MD5/MD9) from the country of origin
- Free Sale Certificate issued by the regulatory authority of the exporting country
- ISO 13485:2016 certificate
- CE Certificate or Equivalent International Certification
- Device and Plant Master Files
- Wholesale Drug License or Distributor License in India
- Company Constitution documents
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Document Preparation | 2 to 3 weeks |
| License Application (MD5) | Immediate after docs |
| Audit by Notified Body | 3 to 4 weeks |
| Query Resolution | 2 to 3 weeks |
| Final License Grant | Within 1 week after compliance |
Total expected duration: 3 to 4 months for manufacturing license.
Government Fees and Costs
- Test License (MD13): Typically included in overall licensing costs
- MD5 Manufacturing License:
- Application Fee: Rs. 5,000
- Per Product Fee: Rs. 500 (per device model)
Additional costs to consider:
- Testing laboratory fees (varies by complexity)
- Notified body audit fees (approx Rs. 50,000 to Rs. 1,00,000 depending on scope)
- Document preparation and consultancy costs
We recommend budgeting approximately Rs. 1.5 to 2 Lakhs for the entire licensing process excluding manufacturing setup costs.
Common Challenges and Solutions
Incomplete Documentation: Missing or inconsistent files cause delays. Use comprehensive checklists and consult expert guidelines.
Delayed Testing Results: Engage accredited labs early and verify sample requirements.
Audit Non-Compliance: Prepare your facility per notified body expectations; conduct internal pre-audits.
Query Backlog: Respond promptly and thoroughly to CDSCO queries to avoid processing delays.
Navigating Online Portal: The CDSCO MD Online Portal can be complex; ensure trained personnel handle submissions.
Our extensive experience with 500+ successful CDSCO licensing projects equips us to help you overcome these hurdles efficiently.
Expert Consultation and Support
Leveraging expert regulatory consultants can significantly reduce timelines and improve approval success. Our team offers:
- End-to-end application preparation
- Document drafting and review
- Pre-audit readiness assessment
- Liaising with CDSCO officials and notified bodies
Partnering with seasoned consultants ensures adherence to all statutory requirements and smooth navigation of the regulatory landscape.
Getting Started with Your CDSCO License Application
Ready to enter the Indian market with your tongue-adjustment sleep apnoea treatment system? Follow these practical steps:
- Assess Device Classification: Confirm your device’s Class B status.
- Register on the CDSCO MD Online Portal: Create your company account.
- Gather Required Documents: Use our guides for DMF and PMF preparation.
- Apply for Test License (MD13): Initiate the process early.
- Plan Product Testing: Select a CDSCO-approved testing laboratory.
- Prepare for Audit: Engage a notified body and perform internal audits.
- Submit MD5 Application: Complete Form MD3 with all supporting documents.
- Monitor Application Status: Track progress and respond to queries promptly.
For detailed guidance, explore our MD5 License Guide.
Embarking on this journey with proper planning and expert support will facilitate a successful CDSCO license grant, enabling you to bring your life-enhancing sleep apnoea device to Indian patients safely and compliantly.
