CDSCO License for Liquid chemical sterilants/high level disinfectants.

Comprehensive Guide to CDSCO Licensing for Liquid Chemical Sterilants / High-Level Disinfectants (Class C)

Liquid chemical sterilants and high-level disinfectants play a critical role in healthcare by ensuring the sterility of critical and semicritical medical devices prior to patient use. Classified as Class C medical devices under the CDSCO framework, these products require rigorous regulatory compliance before they can be manufactured or imported into India. With over 25 years of experience helping 500+ companies successfully navigate CDSCO licensing, we provide this in-depth guide tailored specifically to liquid chemical sterilants to help you understand the regulatory landscape, streamline your licensing process, and avoid common pitfalls.

CDSCO Regulatory Framework for Liquid Chemical Sterilants

The Central Drugs Standard Control Organization (CDSCO) oversees the regulation of medical devices in India under the Medical Device Rules (MDR) 2017. Liquid chemical sterilants fall under the category of General Hospital or Orthopaedic Instruments, notified under 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. Given their critical role in infection control, these devices are classified as Class C, which demands central licensing authority involvement and stringent compliance.

Risk Classification and License Requirements for Class C Devices

Class C devices, including liquid chemical sterilants, are considered moderate-to-high risk and require a manufacturing license under the MD9 form (Application Form MD7) issued by the central licensing authority. Importers must secure an import license (MD15) from CDSCO.

• Manufacturing License: MD9 license (Form MD7) granted by CDSCO Central Licensing Authority
• Import License: MD15 license (Form MD14) granted by CDSCO Central Licensing Authority

Manufacturing License Process for Class C Liquid Chemical Sterilants (MD9 License)

Obtaining an MD9 manufacturing license is a multi-step process:

1. Test License Application (Form MD13): Initiate the process by applying for a test license to manufacture, test, and analyze the product. This license is valid for 12 months and takes approximately 1.5 to 2 months to obtain.

2. Product Testing: Conduct mandatory product testing at CDSCO-approved government laboratories. You can find the list of testing laboratories authorized for such evaluations.

3. Document Preparation: Gather and prepare comprehensive documentation including technical files and quality management system evidence.

4. License Application (Form MD7): Submit the MD9 manufacturing license application through the CDSCO MD Online Portal.

5. Inspection and Audit: CDSCO inspectors conduct a detailed audit of your manufacturing facility and quality systems.

6. Query Resolution: Respond promptly and accurately to any queries raised by CDSCO during the review.

7. License Grant: Upon successful audit and document verification, CDSCO issues the manufacturing license (Form MD9).

Manufacturing License Documents Required for MD9

For liquid chemical sterilants, the following documents are essential:

• Company Constitution (Incorporation certificate, MoA, AoA)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (Refer to our Device Master File guide)
• Plant Master File (See our Plant Master File guide)
• Essential Principles Checklist demonstrating compliance with Indian MDR
• Risk Management File outlining hazard analysis and mitigation strategies (Risk Management insights)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU) compliant with Indian regulations
• Quality Management System Documents demonstrating ISO 13485 compliance

Import License Process for Liquid Chemical Sterilants (MD15 License)

For importers of liquid chemical sterilants into India, the MD15 license is mandatory. The process includes:

1. Document Preparation: Assemble all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE certificate, and other technical dossiers.

2. License Application: Submit application via the CDSCO MD Online Portal using Form MD14.

3. Review and Queries: CDSCO reviews the application and may raise queries requiring prompt responses.

4. License Grant: Once compliance is verified, the import license (Form MD15) is granted.

Import License Documents Required for MD15

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

Note: Timelines may vary depending on audit scheduling, query resolution speed, and completeness of submissions.

Government Fees and Costs

• MD9 Manufacturing License: Application fee Rs 50,000 + Rs 1,000 per product
• Test License (MD13): Included in overall process costs
• Import License (MD15): For Class C devices, Rs 3,000 per site + Rs 1,500 per product

Additional costs include:

• Product testing fees at approved labs
• Fees charged by notified bodies or consultants
• Compliance-related expenses such as QMS implementation

Common Challenges and Solutions

• Incomplete Documentation: Many applicants underestimate the depth and detail required in technical files and risk management. Solution: Use a checklist and consult with experienced regulatory experts.

• Delays in Testing: Backlogs at testing labs can delay approval. Solution: Plan well in advance and engage labs early.

• Audit Non-Compliance: Facilities not adhering to QMS or GMP principles often fail audits. Solution: Conduct internal audits and mock inspections.

• Query Resolution Delays: Slow responses to CDSCO queries prolong timelines. Solution: Assign a dedicated regulatory liaison to manage communications.

Expert Consultation and Support

With decades of experience and over 500 successful CDSCO license applications in our portfolio, we guide you through every step—from document preparation to audit readiness and query management. Our support ensures you avoid common pitfalls and accelerate your time to market.

Getting Started with Your CDSCO License Application for Liquid Chemical Sterilants

1. Assess Your Device Classification: Confirm your device falls under Class C based on the latest Medical Device Classification.

2. Gather Preliminary Documents: Prepare company registration, premises documents, and technical staff qualifications.

3. Apply for Test License (MD13): Initiate the test license application via the CDSCO MD Online Portal.

4. Plan Product Testing: Coordinate with approved testing laboratories.

5. Prepare Device and Plant Master Files: Use our detailed guides to ensure thorough documentation.

6. Engage with Notified Bodies: For audits, consult the list of notified bodies authorized for Class C devices.

7. Submit MD9 License Application: Once test license and product testing are complete, file your manufacturing license application.

8. Prepare for Audit and Queries: Conduct internal reviews to ensure smooth inspections.

By following these practical steps and leveraging expert support, manufacturers and importers can confidently secure CDSCO licenses for liquid chemical sterilants and access the Indian healthcare market efficiently.

For personalized assistance and to streamline your CDSCO licensing journey, contact our regulatory experts today.