CDSCO License for Ultrasonic cleaner for medical instruments.

Introduction: Ultrasonic Cleaner for Medical Instruments and Regulatory Importance

Ultrasonic cleaners for medical instruments are integral to maintaining hygiene and infection control in healthcare settings. These devices use high-frequency sound waves to clean surgical and orthopedic instruments effectively, ensuring patient safety and device longevity. Given their medical application and potential risk, ultrasonic cleaners fall under Class B risk classification as per CDSCO regulations. Compliance with CDSCO licensing is mandatory before marketing or manufacturing these devices in India.

With over 25 years of experience assisting 500+ companies globally, we understand the nuances of CDSCO approvals. This guide offers a comprehensive roadmap for manufacturers and importers of ultrasonic cleaners to navigate the regulatory landscape efficiently.

CDSCO Regulatory Framework for Ultrasonic Cleaners

The Central Drugs Standard Control Organization (CDSCO) oversees medical device regulation in India. Ultrasonic cleaners for medical instruments are categorized under "General Hospital or Orthopaedic Instruments" and notified under Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. As a Class B device, these cleaners require a manufacturing license (MD5) granted by the State Licensing Authority.

CDSCO mandates strict adherence to quality, safety, and efficacy standards, including compliance with ISO 13485:2016 and essential principles outlined in the Medical Device Rules, 2017.

Risk Classification and License Requirements for Ultrasonic Cleaners

According to the Medical Device Classification, ultrasonic cleaners fall into Class B due to their moderate potential risk associated with cleaning medical instruments.

• License Type: MD5 Manufacturing License
• Authority: State Licensing Authority
• Application Form: MD3

Manufacturers must complete the entire licensing cycle, including test licenses, product testing, audits, and documentation before receiving the MD5 license.

Manufacturing License Process (MD5) for Ultrasonic Cleaners

1. Obtain Test License (Form MD13): Initiate by applying for a test license, which typically takes 1.5 to 2 months. This allows manufacturing the product for testing purposes.

2. Product Testing: Submit ultrasonic cleaner samples to CDSCO-approved testing laboratories (Testing Laboratories) for conformity to standards. Testing duration ranges from 4 to 6 weeks.

3. Documentation Preparation: Compile detailed technical documentation, including Device Master File and Plant Master File.

4. Apply for MD5 License (Form MD3): Submit the application through the CDSCO MD Online Portal for manufacturing license issuance.

5. Audit by Notified Body: A notified body audit is mandatory. Review the list of notified bodies to select an authorized auditor. The audit focuses on manufacturing processes, quality management systems, and compliance with the Medical Device Rules.

6. Query Resolution: Address any queries or observations raised by the licensing authority or notified body promptly.

7. Grant of License: Upon satisfactory compliance, the MD5 license is granted on Form MD5, authorizing manufacturing of ultrasonic cleaners.

Manufacturing License Documents Required

To streamline your application, ensure the following documents are meticulously prepared:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership or lease agreement for manufacturing premises
• Qualifications and experience certificates of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed design and technical specifications (Device Master File guide)
• Plant Master File (PMF): Description of manufacturing facility and processes (Plant Master File guide)
• Essential Principles Checklist outlining compliance with safety and performance standards
• Risk Management File detailing hazard analysis and mitigation strategies (Risk Management)
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process (MD15) for Ultrasonic Cleaners

For importers of ultrasonic cleaners, the MD15 import license is required, issued by the Central Licensing Authority.

• Application Form: MD14
• No Test License Required: Unlike manufacturing, importers need not apply for a test license.

Steps to Apply:

1. Gather required documents including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.

2. Submit the application via the CDSCO MD Online Portal.

3. Respond promptly to any departmental queries.

4. Upon compliance, the MD15 import license is granted, typically within 5 to 6 months.

For detailed guidance, refer to our Import License Guide.

Import License Documents Required

• Valid Manufacturing License of the device from the country of origin
• Free Sale Certificate affirming device marketability abroad
• ISO 13485:2016 Certificate (QMS)
• CE Certificate or equivalent conformity
• Device Master File
• Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

Import license (MD15) typically requires 5 to 6 months due to central authority processing timelines.

Government Fees and Costs

• MD5 License Fees:

  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

• Additional Costs:

  • Testing fees at government-approved labs (vary by test complexity)
  • Notified body audit fees (varies by auditor)
  • Documentation preparation and consulting fees (variable)

These fees are essential investments to ensure regulatory compliance and smooth market access.

Common Challenges and Solutions

Challenge 1: Delays in Testing and Audit

Solution: Initiate test license and product testing early. Choose notified bodies with proven track records and confirm audit schedules well in advance.

Challenge 2: Incomplete Documentation

Solution: Use comprehensive checklists and templates for Device Master File and Plant Master File. Engage expert consultants to review submissions.

Challenge 3: Query Backlog and Miscommunication

Solution: Maintain active communication with CDSCO officials and auditors. Provide clear, prompt responses to avoid processing delays.

Challenge 4: Understanding Complex Regulatory Language

Solution: Partner with experienced regulatory consultants who can translate requirements into actionable plans.

Expert Consultation and Support

With a legacy spanning 25+ years and over 500 successful CDSCO license approvals, our expert team is uniquely positioned to guide you through every regulatory hurdle. From pre-application audits to post-approval compliance, we provide tailored solutions for ultrasonic cleaner manufacturers and importers.

Our services include:

• Gap analysis and readiness assessment
• Documentation drafting and review
• Test license and product testing coordination
• Liaison with notified bodies and CDSCO authorities
• Training on regulatory updates and compliance

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your ultrasonic cleaner falls under Class B and requires an MD5 license.

2. Prepare Your Facility: Ensure your manufacturing site complies with Good Manufacturing Practices (GMP) and has necessary NOCs.

3. Gather Core Documents: Start compiling company constitution, staff qualifications, and quality management certificates.

4. Apply for Test License (Form MD13): Submit your initial application via the CDSCO MD Online Portal.

5. Engage a Notified Body Early: Identify and initiate contact with notified bodies to schedule your audit.

6. Plan Product Testing: Coordinate sample testing at approved laboratories to avoid delays.

7. Leverage Expert Help: Consider consulting with experienced regulatory experts to optimize your application quality and reduce approval timelines.

Embarking on your CDSCO licensing journey with detailed planning and expert guidance will pave the way for successful market entry of your ultrasonic cleaner in India’s growing medical device sector.