CDSCO License for Dry-heat sterilizer.

Comprehensive CDSCO Licensing Guide for Dry-Heat Sterilizers (Class C Medical Device)

As specialists with over 25 years of experience and having successfully guided more than 500 companies through the regulatory maze, we understand the critical importance of securing the right CDSCO license for your dry-heat sterilizer. These devices, classified as Class C under the Indian regulatory framework, play a pivotal role in sterilizing medical instruments using dry heat and are essential in healthcare settings like hospitals and orthopaedic clinics.

Understanding Your Dry-Heat Sterilizer and Its Regulatory Importance

A dry-heat sterilizer is designed to eliminate microbes on medical devices through controlled exposure to high temperatures without moisture. Given its direct impact on patient safety, the Central Drugs Standard Control Organization (CDSCO) mandates stringent licensing to ensure compliance with quality and safety standards.

CDSCO Regulatory Framework for Dry-Heat Sterilizers

Under the Medical Device Rules, 2017 (amended), dry-heat sterilizers fall under Class C, indicating a moderate to high risk. The regulatory process is governed by the Central Licensing Authority (CLA) and requires a Manufacturing License under the MD9 category.

Risk Classification and License Requirements for Dry-Heat Sterilizers

• Risk Class: C (Moderate-High Risk)
• License Type: MD9 Manufacturing License
• Application Form: MD7
• Authority: Central Licensing Authority (CDSCO Headquarters)

The classification aligns with the notification number 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022, which specifically includes dry-heat sterilizers under medical device regulations.

Manufacturing License Process (MD9) for Class C Devices

1. Obtain Test License (Form MD13): Before applying for MD9, you must secure a test license. This process typically takes 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at government-approved laboratories. Refer to the list of approved testing laboratories to select an authorized lab.
3. Document Compilation: Prepare comprehensive dossiers including Device Master File and Plant Master File.
4. Application Submission: File your MD9 application through the CDSCO MD Online Portal.
5. Inspection and Audit: CDSCO inspectors will audit your manufacturing facility and quality systems.
6. Query Resolution: Address any queries or deficiencies raised during the audit process.
7. License Grant: Upon successful completion, the license is granted on Form MD9.

For a detailed walkthrough, consult our MD9 License Guide.

Essential Documents Required for MD9 License Application

• Company Constitution Documents: Incorporation certificate, partnership deed, or LLP agreement
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Details: CVs, qualifications, and experience of key personnel
• Fire and Pollution NOCs: No Objection Certificates from relevant authorities
• Device Master File (DMF): Detailed device specifications, manufacturing processes, and design control. Our Device Master File guide can assist in proper preparation.
• Plant Master File (PMF): Comprehensive overview of manufacturing premises and quality systems. Learn how to create this in our Plant Master File guide.
• Essential Principles Checklist: Compliance matrix with Indian medical device rules and standards
• Risk Management File: Documentation of risk analysis and mitigation strategies. Effective risk management is critical; see our guide on Medical Device Risk Management.
• Test Reports: From government-approved labs validating safety and performance
• Labels and Instructions for Use (IFU): As per regulatory standards
• Quality Management System (QMS) Documents: ISO 13485 certification and related quality manuals

Import License Process (MD15) for Dry-Heat Sterilizers

If you are an importer, the procedure involves obtaining an MD15 license from CDSCO's Central Authority. The process generally takes 5-6 months and requires:

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate
• ISO 13485:2016 and CE Certificate
• Device Master File & Plant Master File
• Wholesale License
• Company Constitution

Submit the application on the CDSCO MD Online Portal. For detailed guidance, our Import License Guide provides actionable insights.

Timeline and Processing Duration

Government Fees and Costs

• Application Fee: ₹50,000 per MD9 application
• Product Fee: ₹1,000 per product
• Test License Fee: Additional charges apply during MD13 application

These fees are payable online via the CDSCO portal. Budgeting for these costs early prevents unexpected delays.

Common Challenges and Solutions

• Delayed Test Reports: Testing labs often have backlogs. Early booking with government-approved labs is crucial.
• Incomplete Documentation: Missing or inconsistent files cause query backlogs. Use our document checklists and templates to ensure completeness.
• Audit Non-compliance: Facilities not meeting GMP or QMS standards face audit failures. Pre-audit mock inspections can identify gaps.
• Query Resolution Delays: Timely and precise responses to CDSCO queries expedite approvals.

Expert Consultation and Support

Navigating CDSCO regulations can be complex, especially for Class C devices like dry-heat sterilizers. Our expert team offers tailored regulatory consulting, document preparation, audit readiness, and liaison with CDSCO to speed up your licensing process. Contact us for personalized assistance to avoid common pitfalls.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your device class using the Medical Device Classification tool.
2. Prepare your test license (MD13) application: Start early, as this initiates your licensing journey.
3. Select government-approved testing labs: Reference the CDSCO approved Testing Laboratories list.
4. Compile required documents: Leverage our Device Master File and Plant Master File guides to expedite preparation.
5. Register and submit your application: Use the official CDSCO MD Online Portal for all submissions.
6. Plan for audits: Schedule internal audits and prepare for CDSCO inspections.

Our proven methodology ensures that dry-heat sterilizer manufacturers and importers meet all regulatory benchmarks efficiently and compliantly. Reach out today to start your licensing journey with confidence.