CDSCO License for Mobile steam washer/disinfector

Comprehensive CDSCO License Guide for Mobile Steam Washer/Disinfector (Class C Medical Device)

With over 25 years of experience and having assisted more than 500 companies successfully navigate the Indian regulatory landscape, we understand the importance of a streamlined approach when securing your CDSCO license. This guide dives deeply into the regulatory requirements for a mobile steam washer/disinfector, a Class C medical device used primarily in pediatrics and neonatology for high-level disinfection of medical equipment via steam application.

Understanding the Mobile Steam Washer/Disinfector and Its Regulatory Importance

The mobile steam washer/disinfector is an electrically powered, mobile unit designed for cleaning and disinfecting critical medical devices like operating tables, neonatal incubators, and surgical instruments. Given its direct contact with high-risk medical devices, the Indian regulatory authorities have classified it as a Class C device under the CDSCO framework, necessitating stringent compliance and licensing.

This classification and regulatory oversight ensure patient safety, product efficacy, and adherence to Indian standards, making CDSCO licensing a non-negotiable step for manufacturers and importers aiming to enter the Indian market.

CDSCO Regulatory Framework for Mobile Steam Washer/Disinfector

The Central Drugs Standard Control Organization (CDSCO) administers the regulatory framework governing medical devices in India. For Class C devices such as the mobile steam washer/disinfector, the licensing responsibility falls under the Central Licensing Authority.

The license type required is the MD9 manufacturing license, as per the Medical Device Rules 2017. This license involves multiple phases: test license procurement, product testing, documentation, application submission, and regulatory audits.

Risk Classification and License Requirements

• Device Risk Class: Class C
• License Required: MD9 Manufacturing License (Application Form MD7)
• Authority: Central Licensing Authority (CDSCO HQ)

Class C devices are considered moderate to high risk, necessitating rigorous evaluation, including testing and regulatory inspection.

Manufacturing License Process for MD9 (Class C Devices)

The manufacturing license process involves several critical steps:

1. Test License Application (Form MD13): Required before full-scale manufacturing. Typically takes 1.5 to 2 months to process.
2. Product Testing: Conducted at government-approved testing laboratories to ensure compliance with Indian standards. Testing duration depends on the lab but generally spans 3-4 weeks.
3. Documentation Preparation: Compilation of technical files, risk management, and quality management system documents.
4. License Application Submission (Form MD7): Submitted via the CDSCO MD Online Portal.
5. Regulatory Audit: Conducted by CDSCO inspectors to verify facility compliance and QMS implementation.
6. Query Resolution: Timely responses to any queries or deficiencies raised during audit or document review.
7. Grant of License (Form MD9): Upon successful completion of all steps.

Manufacturing License Documents Required for Mobile Steam Washer/Disinfector

Manufacturers must prepare a comprehensive dossier, including:

• Certificate of Incorporation and Company Constitution
• Proof of ownership or lease agreement for manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device description, manufacturing process, and validation (Device Master File Guide)
• Plant Master File (PMF): Overview of manufacturing facilities and quality controls (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File outlining identified hazards and mitigation strategies (Risk Management)
• Test Reports from government-approved labs (Testing Laboratories)
• Labels, packaging inserts, and Instructions for Use (IFU)
• Quality Management System (QMS) documentation such as ISO 13485 certificates

Import License Process for Mobile Steam Washer/Disinfector (MD15)

For importers, a separate MD15 import license is required, issued by the Central Licensing Authority. The process involves:

1. Document preparation including manufacturing license from the country of origin, Free Sale Certificate, and ISO 13485 certification.
2. Application submission on the CDSCO MD Online Portal.
3. Departmental review and queries.
4. Grant of import license (Form MD15).

Unlike manufacturing licenses, test licenses are not mandatory for import licensing. However, all documentation must be robust and compliant.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

These timelines are average estimates; delays can occur due to incomplete documentation or audit scheduling.

Government Fees and Costs

For Class C devices like the mobile steam washer/disinfector, the fee structure is as follows:

It is important to budget for additional costs such as testing fees at government-approved labs and audit-related expenses.

Common Challenges and Practical Solutions

• Incomplete Documentation: Many applicants face rejections due to missing or inconsistent documents. We recommend using detailed checklists and engaging early with notified bodies.

• Audit Preparation: Insufficient QMS implementation can delay audits. Conduct internal mock audits before CDSCO inspections.

• Testing Delays: Coordinate with government-approved labs in advance; submit samples promptly upon test license issuance.

• Query Management: Respond to CDSCO queries comprehensively and within stipulated timelines to avoid application rejection.

• Notified Body Selection: Choose from the CDSCO list of notified bodies experienced with Class C devices to ensure a smooth audit process.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape for Class C devices requires expertise and experience. With decades of assisting medical device companies, we provide:

• End-to-end license application support
• Documentation preparation and review
• Liaison with CDSCO and notified bodies
• Risk management and QMS implementation guidance
• Training for internal audit readiness

Our proven track record ensures your mobile steam washer/disinfector meets all regulatory requirements for swift market entry.

Getting Started with Your CDSCO License Application

1. Assess your device classification and intended use: Confirm Class C status per the official Medical Device Classification.

2. Initiate test license (MD13) application: Submit via the CDSCO MD Online Portal to commence product testing.

3. Engage a notified body: Select an approved notified body early from the official list for audit planning.

4. Compile all mandatory documents: Utilize our comprehensive DMF and PMF guides to ensure completeness.

5. Prepare your quality management system: Align with ISO 13485 and prepare for audit scrutiny.

6. Submit MD9 license application (Form MD7): After successful testing, proceed with the full manufacturing license application.

7. Respond promptly to queries: Maintain an efficient communication channel with CDSCO to facilitate smooth processing.

By following these actionable steps and leveraging expert guidance, manufacturers and importers can efficiently secure their CDSCO licenses for the mobile steam washer/disinfector, unlocking access to the growing Indian healthcare market.

For detailed assistance, contact our regulatory consultants who specialize in medical device licensing across India.