CDSCO License for Medical washer-disinfector.

Comprehensive Guide to CDSCO Licensing for Medical Washer-Disinfector (Class B)

As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 medical device companies, we understand the critical importance of securing the correct CDSCO license to enter the Indian market confidently and compliantly. In this detailed guide, we focus on the Medical Washer-Disinfector—a Class B medical device used extensively in hospitals and surgical centers—and outline the step-by-step process to obtain the CDSCO manufacturing license (MD5), including timelines, costs, and essential documentation.

Introduction: Medical Washer-Disinfector Overview and Regulatory Importance

A Medical Washer-Disinfector is a vital device designed for the cleaning, decontamination, disinfection, and drying of surgical instruments, anesthesia equipment, hollowware, and other reusable medical devices. Classified under General Hospital or Orthopaedic Instruments, this device plays a pivotal role in infection control protocols. Given its direct impact on patient safety, regulatory compliance is non-negotiable.

Notification 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022, officially classifies this device as Class B under the CDSCO framework. Compliance with CDSCO ensures that your product meets Indian standards for safety and efficacy, facilitating smooth market entry.

CDSCO Regulatory Framework for Medical Washer-Disinfector

The Central Drugs Standard Control Organization (CDSCO) oversees medical device regulation in India. The regulatory framework for Medical Washer-Disinfectors falls under the Medical Device Rules, 2017, mandating a manufacturing license from the State Licensing Authority via the MD5 license process for Class A and B devices.

This structured approach ensures manufacturers adhere to quality management systems, conduct appropriate product testing, and maintain rigorous documentation.

Risk Classification and License Requirements for Class B Devices

Medical Washer-Disinfectors are classified as Class B due to their moderate risk level. This classification means:

• You must apply for an MD5 manufacturing license using Form MD3.
• The licensing authority is the State Licensing Authority.
• A test license (Form MD13) is mandatory before applying for the manufacturing license.
• Product testing must be conducted at government-approved laboratories.

For more information on medical device classification, explore our Medical Device Classification guide.

Manufacturing License Process (MD5) for Medical Washer-Disinfector

The MD5 license process involves several sequential steps:

1. Test License Application (Form MD13): Apply via the CDSCO MD Online Portal for a test license. This license allows you to legally manufacture the Medical Washer-Disinfector for testing purposes.
2. Product Testing: Send your product samples to CDSCO-approved testing laboratories. Refer to the Testing Laboratories list to select an accredited lab.
3. Document Preparation: Compile all required documentation, including technical, quality, and regulatory files.
4. Apply for MD5 License (Form MD3): Submit your manufacturing license application through the online portal.
5. Audit by Notified Body: A notified body will conduct a facility audit to verify compliance. Find a suitable auditor in the Notified Bodies list.
6. Query Resolution: Address any observations or queries raised by the authorities or notified body.
7. License Grant: Upon successful completion, the State Licensing Authority issues the MD5 manufacturing license.

Manufacturing License Documents Required for Medical Washer-Disinfector

Preparing a comprehensive documentation package is vital for a smooth licensing process. Key documents include:

• Company Constitution Proof: Registration certificate, incorporation documents.
• Premises Proof: Ownership or lease agreement of manufacturing site.
• Technical Staff Details: Qualification certificates and experience of technical personnel.
• Fire NOC and Pollution Control NOC: To demonstrate compliance with safety and environmental norms.
• Device Master File (DMF): Detailed design, development, and manufacturing information. Our Device Master File guide provides valuable insights.
• Plant Master File (PMF): Facility layout, equipment details, and process descriptions. Consult our Plant Master File guide for preparation tips.
• Essential Principles Checklist: Compliance with Indian Medical Devices Rules.
• Risk Management File: Documentation of risk assessment and mitigation strategies. Learn more at our Risk Management guide.
• Test Reports: From government-approved labs.
• Labels and Instructions for Use (IFU): As per CDSCO labeling requirements.
• Quality Management System Documents: Typically ISO 13485:2016 certification and internal quality procedures.

Import License Process (MD15) for Medical Washer-Disinfector

If you are an importer looking to bring Medical Washer-Disinfectors into India, the MD15 import license is mandatory. This license is issued by the Central Licensing Authority and involves:

• Document preparation including manufacturing license, Free Sale Certificate, CE Certificate, ISO 13485:2016 certificate, Device and Plant Master Files.
• Application submission using Form MD14 on the CDSCO MD Online Portal.
• Resolution of any authority queries.
• License issuance typically within 5-6 months.

Detailed guidance can be found in our Import License guide.

Import License Documents Required

Required documents for MD15 include:

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

Timeline and Processing Duration for MD5 License

The entire MD5 licensing process for Class B Medical Washer-Disinfectors typically spans 3 to 4 months, broken down as follows:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 2 to 4 weeks (depending on lab backlog)
• Document preparation: Concurrent with testing phase
• Audit and Review: 3 to 4 weeks
• Query resolution and final approval: 2 to 3 weeks

Prompt and thorough response to queries significantly reduces delays.

Government Fees and Costs

The fee structure for MD5 licenses is as follows:

• Application Fee: INR 5,000 per application
• Product Fee: INR 500 per product

Additional costs may include:

• Fees for product testing at government-approved labs
• Notified body audit charges
• Consultant fees for document preparation and application support

Common Challenges and Solutions

Challenge: Delays in test license approval and product testing. Solution: Submit complete applications with accurate information and choose testing labs with shorter lead times.

Challenge: Incomplete or inconsistent documentation causing audit non-compliance. Solution: Use standardized templates and checklists for Device and Plant Master Files. Engage experienced consultants.

Challenge: Queries from CDSCO or notified bodies causing prolonged approvals. Solution: Prepare detailed, evidence-backed responses promptly. Maintain continuous communication with authorities.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex, but with our 25+ years of expertise and a track record of over 500 successful client approvals, we provide end-to-end support:

• Assessing your device classification and regulatory strategy
• Preparing and reviewing all technical and regulatory documentation
• Coordinating testing and notified body audits
• Managing online submissions and query resolution

Our proactive approach minimizes approval timelines and ensures compliance with evolving regulations.

Getting Started with Your CDSCO License Application

For manufacturers of Medical Washer-Disinfectors, the practical next steps are:

1. Register on the CDSCO MD Online Portal: Setup your company profile and familiarize yourself with submission procedures.
2. Apply for the Test License (Form MD13): Prepare initial documentation and submit to begin legal manufacturing for testing.
3. Identify Government Approved Testing Laboratory: Engage early to schedule product testing.
4. Develop Complete Documentation: Device Master File, Plant Master File, Risk Management, QMS documents, and labeling.
5. Schedule Audit With Notified Body: Select an auditor from the Notified Bodies list and prepare your facility.

By following these actionable steps and leveraging expert consultation, you can streamline your journey to obtaining the MD5 manufacturing license and successfully bring your Medical Washer-Disinfector to the Indian healthcare market.

For detailed assistance, contact our regulatory experts today to initiate your CDSCO licensing process with confidence.