CDSCO License for Dry salt therapy device
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A hand-held inhaler prefilled with salt crystals and used to provide an inhalation of salt particles through the mouth and into the bronchial airways to induce natural self-cleansing mechanisms that flush away the impurities from the surface of cells and mechanically clean the airways.
Introduction to Dry Salt Therapy Device and Regulatory Importance
Dry salt therapy devices, such as hand-held inhalers prefilled with salt crystals, have grown popular in respiratory care for their natural mechanism that aids in cleansing bronchial airways. These devices help flush impurities and mechanically clean the respiratory tract, offering a non-invasive alternative for respiratory health management. Given their direct impact on respiratory function, even though classified as low risk, regulatory compliance in India is critical to ensure safety, efficacy, and market access.
With over 25 years of experience and having assisted more than 500 companies, we understand that navigating the CDSCO licensing framework for medical devices like the dry salt therapy inhaler can be complex. This device falls under Class A—the lowest risk category—requiring specific licensing under the MD5 framework. Proper adherence to regulatory requirements not only ensures legal market entry but also builds trust with healthcare providers and end-users.
CDSCO Regulatory Framework for Dry Salt Therapy Devices
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017 (MDR). Dry salt therapy devices are categorized under respiratory devices and classified as Class A, reflecting minimal risk. This classification mandates adherence to the MD5 license process, managed by the State Licensing Authority.
The regulatory process encompasses obtaining a test license (Form MD13), product testing at CDSCO-approved laboratories, technical documentation preparation, submission of the manufacturing license application (Form MD3), and finally, an audit by a notified body.
Risk Classification and License Requirements for Class A Devices
Our dry salt therapy inhaler is a Class A medical device as per CDSCO’s classification, which includes devices with minimal risk to patients and users. Class A devices require an MD5 manufacturing license issued by the State Licensing Authority.
Key points for Class A devices:
- License Type: MD5 Manufacturing License
- Application Form: MD3
- Issuing Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months
- Test License: Mandatory (Form MD13)
- Testing: Conducted at CDSCO-approved labs
- Audit: By notified body
- Government Fees: Rs. 5,000 application fee + Rs. 500 per product
For detailed classification, you can refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Dry Salt Therapy Devices
The MD5 license process involves several critical steps:
- Obtain Test License (Form MD13): Apply for and secure a test license, which takes approximately 1.5 to 2 months. This allows product testing in government-approved labs.
- Product Testing: Submit the dry salt therapy device for testing at laboratories listed on the CDSCO Testing Laboratories portal. Testing typically covers safety, performance, and material compliance.
- Documentation Preparation: Compile all necessary documentation, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
- Apply for Manufacturing License (Form MD3): Submit the application via the CDSCO MD Online Portal along with requisite documents and fees.
- Audit by Notified Body: Coordinate with a notified body from the official list for audit of your manufacturing facilities and processes.
- Query Resolution: Respond promptly to any queries or observations raised by the CDSCO or notified body.
- License Grant: Upon satisfactory audit and documentation review, the MD5 license is issued.
We recommend early engagement with notified bodies to streamline this process and mitigate delays.
Manufacturing License Documents Required for Dry Salt Therapy Devices
For the MD5 license application, manufacturers must submit comprehensive documentation, including:
- Company Constitution (Incorporation Certificate, MoA & AoA)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and qualifications of technical staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed device description, design, and manufacturing process (Learn more here)
- Plant Master File (PMF): Facility layout, equipment, and quality control systems (Guide here)
- Essential Principles Checklist confirming compliance with MDR 2017
- Risk Management File specific to the dry salt therapy device (Risk Management guide)
- Product Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System documents (ISO 13485:2016 compliance preferred)
Attention to detail in documentation reduces the risk of queries and expedites license approval.
Import License Process (MD15) for Dry Salt Therapy Devices
While this guide primarily focuses on manufacturing licenses, importers of dry salt therapy devices must obtain the MD15 import license issued by the Central Licensing Authority. The process includes:
- Comprehensive documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate if applicable
- Submission of application on the CDSCO MD Online Portal
- Processing time of 5-6 months
For detailed guidance on import licensing, refer to our Import License Guide.
Timeline and Processing Duration for MD5 License
Based on extensive experience, the following timeline is typical for a Class A dry salt therapy device:
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Documentation Preparation | 2 - 3 weeks |
| Application Submission | Immediate upon readiness |
| Audit by Notified Body | 3 - 4 weeks |
| Query Resolution | 2 - 3 weeks |
| License Grant | Within 1 week post audit |
Total Estimated Time: 3 to 4 months
Proactive planning and early engagement with notified bodies can shorten this timeline.
Government Fees and Costs for MD5 License
The fee structure for the MD5 license for Class A devices is transparent:
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per device
Additional costs to consider include:
- Testing fees at government-approved labs
- Audit fees payable to notified bodies
- Costs for document preparation and consultancy, if applicable
Budgeting for these costs upfront prevents unexpected financial hurdles.
Common Challenges and Solutions in CDSCO Licensing for Dry Salt Therapy Devices
Challenge: Delays in product testing due to limited lab slots.
Solution: Schedule testing appointments well in advance and ensure your samples meet submission criteria.
Challenge: Incomplete or non-compliant documentation leading to queries.
Solution: Leverage expert consultation to prepare thorough and compliant Device Master Files and Risk Management documentation.
Challenge: Audit non-conformities related to facility compliance.
Solution: Conduct internal pre-audits and gap assessments to ensure readiness.
Challenge: Understanding regulatory updates and notifications.
Solution: Regularly monitor CDSCO updates and consult updated notifications. Our team provides timely regulatory alerts to clients.
Expert Consultation and Support
With over 25 years of regulatory expertise, we specialize in facilitating seamless CDSCO licensing for medical devices including dry salt therapy inhalers. Our services include:
- End-to-end application management on the CDSCO MD Online Portal
- Preparation of Device and Plant Master Files
- Coordination with notified bodies and testing labs
- Pre-audit readiness assessments
- Regulatory compliance training
Partnering with seasoned consultants reduces time-to-market and mitigates regulatory risks.
Getting Started with Your CDSCO License Application for Dry Salt Therapy Devices
To begin your licensing journey:
- Assess Device Classification: Confirm your device’s Class A status.
- Prepare Test Samples: Ensure batches of your dry salt therapy inhalers are ready for testing.
- Apply for Test License (Form MD13): Submit this application early via the CDSCO MD Online Portal.
- Gather Documentation: Assemble technical files, master files, and quality system documents.
- Identify Notified Body: Select a suitable notified body from the official list and initiate audit scheduling.
- Engage Expert Support: Consult with regulatory professionals for document review and application strategy.
Early preparation and strategic execution are key to a successful licensing process. Contact us to leverage our proven track record and industry insights to secure your MD5 license efficiently.
Embark on your regulatory journey today to bring your innovative dry salt therapy device to the growing Indian respiratory health market.
