CDSCO License for Boiling water sterilizer

Comprehensive Guide to CDSCO Licensing for Boiling Water Sterilizers (Class B Medical Device)

Boiling water sterilizers are vital devices designed to inactivate microorganisms on medical and dental instruments using heated water. Predominantly used in pediatric and neonatology settings, especially in remote or home environments, these sterilizers ensure safe, germ-free equipment essential for vulnerable populations. Given their critical role, regulatory approval by the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturing and marketing in India.

With over 25 years of expertise helping 500+ companies navigate CDSCO licensing, we provide an in-depth, practical roadmap tailored for manufacturers and importers of boiling water sterilizers (Risk Class B). This guide covers the entire regulatory framework, from risk classification and license types to timelines, costs, and key documentation.

CDSCO Regulatory Framework for Boiling Water Sterilizers

Boiling water sterilizers fall under the pediatric and neonatology category and are classified as Class B medical devices due to their moderate risk profile. The CDSCO regulates these devices under the Medical Device Rules, 2017, which came into effect on January 1, 2018. Compliance ensures that devices meet safety, efficacy, and quality standards before entering the Indian market.

Manufacturers must obtain the appropriate license from the State Licensing Authority (SLA) for Class B devices, specifically the MD5 manufacturing license. Importers require an MD15 import license from the Central Licensing Authority.

To streamline application submissions, the CDSCO MD Online Portal is the primary platform for all regulatory filings, including test licenses, audit scheduling, and final license applications.

Risk Classification and License Requirements

• Risk Class: B (Moderate risk – includes devices that come in contact with mucous membranes or have a medium potential for harm)
• License Type:
  • Manufacturing License: MD5 (Form MD3 application)
  • Test License: MD13 (required before MD5 application for product testing)
  • Import License: MD15 (Form MD14 application)

The classification mandates a robust quality management system and compliance with essential principles, including risk management, labeling, and clinical evaluation tailored to pediatric use.

For a detailed understanding of device classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Boiling Water Sterilizers

Step 1: Obtain Test License (Form MD13)

Before applying for the MD5 manufacturing license, manufacturers must secure a test license allowing sample testing of the sterilizer in government-approved laboratories. This step typically takes 1.5 to 2 months.

Step 2: Product Testing

Samples of the boiling water sterilizer must be tested at CDSCO-recognized labs to confirm compliance with applicable standards, including electrical safety and sterilization efficacy. A list of authorized Testing Laboratories is available on the CDSCO portal.

Step 3: Documentation Preparation

Compile comprehensive documents, including:

• Company Constitution and Incorporation Certificates
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution NOC certificates
• Device Master File (DMF) outlining design and manufacturing details (Device Master File Guide)
• Plant Master File (PMF) documenting facility and equipment (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with safety and performance standards
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from approved labs
• Labels and Instructions for Use (IFU) tailored for pediatric applications
• Quality Management System (QMS) documents aligned with ISO 13485

Step 4: Application Submission

Submit the MD5 license application (Form MD3) through the CDSCO MD Online Portal. The application fee is Rs. 5,000 per application plus Rs. 500 per product (for the boiling water sterilizer, considered one product).

Step 5: Audit by Notified Body

An audit of the manufacturing facility is conducted by a CDSCO-notified body. Manufacturers can refer to the list of notified bodies to identify authorized auditors. The audit verifies compliance with QMS, facility standards, and documentation.

Step 6: Query Resolution

Respond promptly to any queries or observations raised by the CDSCO or notified body during the review process.

Step 7: Grant of License

Upon satisfactory completion of all steps, the State Licensing Authority issues the MD5 manufacturing license (Form MD5), valid for five years.

Manufacturing License Documents Required for Boiling Water Sterilizers

• Company Constitution and Incorporation Certificate
• Proof of Ownership/Lease of Premises
• Details of Technical Staff (Qualification and Experience)
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Compliance Checklist
• Risk Management File
• Government Approved Test Reports
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485 certification recommended)

Ensuring complete and accurate documentation reduces delays and facilitates smooth licensing.

Import License Process (MD15) for Boiling Water Sterilizers

For importers, the MD15 license is mandatory and is granted by the Central Licensing Authority.

Steps:

1. Document Preparation: In addition to manufacturing license and test reports, importers must provide:

   • Free Sale Certificate from the country of origin
   • ISO 13485:2016 certification
   • CE Certificate (if applicable)
   • Wholesale License
   • Company Constitution

2. Application Submission: Apply through the CDSCO MD Online Portal using Form MD14.

3. Queries and Clarifications: Address any regulatory queries promptly.

4. Grant of MD15 License: Usually takes 5 to 6 months.

Fees Structure:

• Class B devices: Rs. 2,000 per site and Rs. 1,000 per product.

Importers should consult our detailed Import License guide for step-by-step assistance.

Timeline and Processing Duration

Planning your regulatory submission with these timelines in mind helps ensure market entry without unexpected delays.

Government Fees and Costs

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• MD13 Test License: Included within MD5 process; nominal fees apply
• MD15 Import License: Rs. 2,000 per site + Rs. 1,000 per product for Class B devices

Additional costs may include testing fees at government-approved labs and audit fees charged by notified bodies.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with essential principles.

Solution: Leverage expert consultation to prepare a comprehensive Device Master File and Plant Master File upfront. Our detailed guides on Device Master Files and Plant Master Files can streamline this process.

Challenge: Difficulty coordinating product testing and audit schedules.

Solution: Early booking of sample testing with approved labs and pre-scheduling audits with notified bodies reduces waiting times. Refer to the official Testing Laboratories and Notified Bodies listings.

Challenge: Navigating regulatory queries and communication gaps.

Solution: Engage experienced regulatory consultants for timely and precise responses, reducing back-and-forth and expediting approvals.

Expert Consultation and Support

With over two decades of experience and more than 500 successful CDSCO license acquisitions, our team provides end-to-end regulatory support:

• Gap analysis and compliance assessment
• Preparation of Device and Plant Master Files
• Coordination of sample testing and audit scheduling
• Application drafting and submission via the CDSCO MD Online Portal
• Query response and liaison with CDSCO authorities

Our tailored approach minimizes risk and accelerates market access for your boiling water sterilizer.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm your boiling water sterilizer as a Class B device.
2. Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and QMS documents.
3. Apply for Test License (MD13): Submit your test license application on the CDSCO MD Online Portal.
4. Schedule Testing: Coordinate product testing with government-approved labs.
5. Apply for Manufacturing License (MD5): Once testing is complete, apply for the MD5 license.
6. Plan for Audit: Arrange for notified body audit and prepare your facility accordingly.

Early engagement with regulatory experts and adherence to timelines ensures a smooth licensing journey. Contact our team today to kickstart your CDSCO licensing process for boiling water sterilizers and secure your foothold in the Indian pediatric medical device market.