CDSCO License for Multi-purpose saline solution
Medical Device Information
Intended Use
A sterile, water-based, salt solution (e.g., sodium chloride isotonic solution) intended for alternative use in multiple applications including inhalation therapy, moisturizing and washing/irrigation of the eyes, nose and ears, and wound cleansing; it is not dedicated to a specific application or part of the anatomy. It is typically available in a squeeze bottle for self-administration or application to infants for preventive or symptomatic care. It is normally available (non-prescription) over-the- counter (OTC) for home use. After application, this device cannot be reused.
Comprehensive Guide to CDSCO Licensing for Multi-purpose Saline Solution (Class B)
As specialists with over 25 years of experience and having supported 500+ companies in navigating the complex landscape of medical device regulation in India, we understand the nuances involved in securing a CDSCO license for devices like the Multi-purpose Saline Solution. This sterile, water-based, salt solution—commonly used in pediatrics and neonatology for inhalation therapy, moisturizing, and wound cleansing—is classified as a Class B medical device under CDSCO regulations. Our goal is to provide you with a clear, actionable roadmap for obtaining your manufacturing or import license efficiently.
Understanding the Device and Regulatory Importance
Multi-purpose saline solutions serve a critical role in home-based and clinical care, especially for infants and pediatric patients. Despite being available over-the-counter, their classification as a Class B device means they require careful regulatory oversight to ensure safety and efficacy. Compliance with CDSCO ensures market access and builds trust among healthcare providers and consumers.
CDSCO Regulatory Framework for Multi-purpose Saline Solution
The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India under the Medical Device Rules (MDR) 2017. For Class B devices like your saline solution, the regulatory pathway involves obtaining a manufacturing license (MD5) from the State Licensing Authority or an import license (MD15) if you plan to import the product.
Risk Classification and License Requirements
Class B devices are considered low-to-moderate risk and include devices like your Multi-purpose Saline Solution. Accordingly, manufacturers must apply for the MD5 license (Form MD3), while importers apply for the MD15 license (Form MD14). The MD5 license is granted by the State Authority, whereas the MD15 and higher-risk licenses are issued by the Central Licensing Authority.
Manufacturing License Process (MD5) for Multi-purpose Saline Solution
The MD5 license process for Class B devices typically spans 3-4 months and involves several key steps:
- Test License Application (Form MD13): Initial step to obtain permission for product testing, taking approximately 1.5 to 2 months.
- Product Testing: Conducted at government-approved laboratories listed on the CDSCO Testing Laboratories portal.
- Documentation Preparation: Compile all required documents including Device Master File and Plant Master File.
- Submission of Manufacturing License Application (Form MD3): Via the CDSCO MD Online Portal.
- Audit by a Notified Body: Select an appropriate notified body from the Notified Bodies List for audit and compliance verification.
- Query Resolution: Respond to any queries raised by the notified body or CDSCO.
- License Grant: Issuance of the MD5 license upon satisfactory compliance.
Manufacturing License Documents Required
For your Multi-purpose Saline Solution, the documentation checklist includes:
- Company Constitution and Incorporation Documents
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- No Objection Certificates (Fire Safety, Pollution Control)
- Device Master File detailing product specifications (Device Master File Guide)
- Plant Master File describing manufacturing processes (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with MDR
- Risk Management File (Risk Management)
- Test Reports from accredited laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 preferred)
Import License Process (MD15) for Multi-purpose Saline Solution
If you are an importer, the MD15 license process takes approximately 5-6 months. Unlike manufacturing licenses, no test license is required beforehand. The steps include:
- Document Preparation: Compile necessary documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, CE Certificate, and ISO 13485:2016 certification.
- Application Submission: Submit Form MD14 via the CDSCO MD Online Portal.
- Query Resolution: Address any CDSCO queries.
- License Grant: Receive MD15 import license for your saline solution.
Import License Documents Required
- Manufacturing License of the exporting company
- Free Sale Certificate from country of origin
- ISO 13485:2016 Quality Management Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Document Preparation | 2 to 4 weeks (varies) |
| Application Submission & Audit | 1.5 to 2 months |
| Query Resolution | 2 to 4 weeks |
| Total Manufacturing License Process | 3 to 4 months |
| Import License Process (MD15) | 5 to 6 months |
Government Fees and Costs
MD5 License (Manufacturing):
- Application Fee: INR 5,000
- Product Fee: INR 500 per product
MD15 License (Import):
- Class B Import Fee: INR 2,000 per site
- Product Fee: INR 1,000 per product
Note: Costs may vary slightly based on the state authority and additional consultancy or audit fees.
Common Challenges and Solutions
- Delays in Product Testing: Select testing laboratories accredited by CDSCO to avoid retesting. Refer to the Testing Laboratories list.
- Incomplete Documentation: Use detailed checklists and templates for Device and Plant Master Files to ensure completeness. Our Device Master File guide can be invaluable.
- Audit Non-compliance: Engage with notified bodies early and prepare your quality management systems thoroughly.
- Query Management: Assign dedicated resources for prompt and clear responses to CDSCO queries to avoid delays.
Expert Consultation and Support
With over two decades of experience assisting medical device companies, we offer end-to-end regulatory consulting—from documentation to audit preparation and application submission. Our expertise in Class B devices like your Multi-purpose Saline Solution ensures you meet all compliance criteria efficiently.
Getting Started with Your CDSCO License Application
- Assess Your Product Classification: Confirm Class B status with the help of our Medical Device Classification resource.
- Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File.
- Apply for Test License (if manufacturing): Submit Form MD13 through the CDSCO MD Online Portal.
- Coordinate Testing: Schedule product testing at CDSCO-approved labs.
- Select a Notified Body: Choose from the list available on the CDSCO portal for audits.
- Submit Manufacturing License Application (MD5): After successful testing and documentation, apply via Form MD3.
- Monitor Application Status: Track progress and respond promptly to queries.
Manufacturers and importers must approach the CDSCO licensing process with diligence and thorough preparation. Leveraging experienced regulatory consultants can dramatically reduce delays and increase approval success rates for your Multi-purpose Saline Solution.
For personalized assistance and to streamline your CDSCO licensing journey, feel free to contact our expert team today.
