CDSCO License for Medical washer.

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

Medical washers play a crucial role in healthcare by efficiently cleaning and drying medical instruments before sterilization or disinfection. Classified as Class B under Indian medical device regulations, these devices fall under the "General Hospital or Orthopaedic Instruments" category as per Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. Navigating the CDSCO licensing process for such devices requires a thorough understanding of the regulatory framework, timelines, and documentation.

With over 25 years of experience and having assisted 500+ companies in successfully obtaining CDSCO licenses, we provide you with an actionable, step-by-step guide tailored specifically for Medical Washers.

CDSCO Regulatory Framework for Medical Washer (Class B)

The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body governing medical devices in India. Devices are categorized by risk class, which determines the licensing authority and process. Being a Class B device, the Medical Washer requires a manufacturing license under the MD5 category, issued by the State Licensing Authority. This regulatory control ensures that the device meets safety and performance standards before entering the market.

Manufacturers must comply with the Medical Device Rules (MDR) 2017 and subsequent notifications, including Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, which specifically lists the Medical Washer under Class B.

Risk Classification and License Requirements

Medical Washers are categorized as Class B due to their indirect contact with patients and moderate risk level associated with failure or malfunction. This designation mandates:

• Obtaining an MD5 Manufacturing License (Form MD3 application) from the State Licensing Authority.
• Compliance with quality management systems aligned with ISO 13485:2016.
• Product testing and audit conducted by notified bodies.

For more on medical device classification, refer to our detailed Medical Device Classification guide.

Manufacturing License Process (MD5) for Medical Washer

The MD5 license process is comprehensive and generally spans 3 to 4 months. It involves several critical steps:

1. Test License (Form MD13): Initially, the manufacturer must apply for a test license, which takes approximately 1.5 to 2 months. This license permits limited manufacturing for product testing.

2. Product Testing: The Medical Washer must be tested in government-approved laboratories to validate safety and efficacy. You can consult the list of testing laboratories accredited by CDSCO.

3. Documentation Preparation: Compile all necessary documents, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. License Application (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is conducted by a notified body listed on the CDSCO portal. Check the list of notified bodies to select an appropriate auditor.

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

7. Grant of MD5 License (Form MD5): Upon successful audit and document verification, the State Licensing Authority grants the manufacturing license.

For a detailed walkthrough, explore our MD5 License Guide.

Manufacturing License Documents Required for Medical Washer

Accurate and comprehensive documentation is vital. The following are mandatory:

• Company Constitution: Incorporation certificates, partnership deeds, or LLP agreements.
• Proof of Ownership or Lease of Manufacturing Premises: Ownership documents or valid lease agreements.
• Technical Staff Details: Qualification certificates and experience profiles of key technical personnel.
• Fire NOC: No-objection certificate from the Fire Department.
• Pollution Control Board NOC: Environmental clearance where applicable.
• Device Master File (DMF): Detailed design, manufacturing process, and specifications of the Medical Washer. Our Device Master File guide helps streamline this process.
• Plant Master File (PMF): Description of the manufacturing facility, equipment, and quality controls. Learn more via our Plant Master File guide.
• Essential Principles Checklist: Compliance checklist aligning with regulatory requirements.
• Risk Management File: Hazard analysis and risk mitigation documentation as per ISO 14971 standards. Consult our Risk Management guide for best practices.
• Test Reports: Lab reports confirming product safety and performance.
• Labels and Instructions for Use (IFU): Samples of labeling and user manuals.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related procedures.

Import License Process (MD15) for Medical Washer

If you intend to import Medical Washers into India, an MD15 Import License from the Central Licensing Authority is mandatory. Unlike manufacturing licenses, the import license process generally takes 5 to 6 months.

Key steps include:

• Document Preparation: Compile manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and company constitution.

• License Application (Form MD14): File your application via the CDSCO MD Online Portal.

• Query Resolution: Engage promptly with CDSCO to resolve any technical or administrative queries.

• Grant of MD15 License: Post-approval, you receive the import license valid for specified products.

Refer to our detailed Import License Guide for stepwise assistance.

Import License Documents Required

• Manufacturing License from the exporting country.
• Free Sale Certificate demonstrating market authorization.
• ISO 13485:2016 Quality Certification.
• CE Certificate or equivalent regulatory approval.
• Device Master File and Plant Master File.
• Wholesale License valid in India.
• Proof of company constitution and registration.

Timeline and Processing Duration

Actual timelines can vary based on document completeness and audit scheduling. Early preparation and proactive query resolution significantly reduce delays.

Government Fees and Costs for Medical Washer Licensing

• MD5 Manufacturing License:

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

• Test License (MD13):

  • Typically included within the manufacturing license process.

• Import License (MD15):

  • For Class B devices, the fee is approximately $2,000 per site and$1,000 per product.

Budgeting for additional costs such as notified body audit fees, testing laboratory charges, and consultancy services is essential.

Common Challenges and Solutions

• Delayed Test Reports: Testing laboratories often have backlogs. Scheduling tests early and choosing labs with shorter turnaround times helps.

• Incomplete Documentation: Missing or inconsistent documents cause application rejections. Use detailed checklists and expert reviews.

• Audit Non-Conformities: Prepare rigorously for notified body audits by aligning processes with ISO 13485 standards.

• Query Backlogs: Engage promptly with CDSCO officials to address queries and avoid prolonged processing.

• Understanding Regulatory Updates: Stay updated with notifications and amendments via the CDSCO website.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex, especially for Class B devices like Medical Washers. Our seasoned regulatory consultants bring over two decades of expertise, having supported 500+ companies through successful approvals. We offer:

• Customized regulatory strategy.
• Documentation preparation and gap analysis.
• Coordination with testing labs and notified bodies.
• Audit readiness and training.
• End-to-end application management on the CDSCO MD Online Portal.

Getting Started with Your CDSCO License Application for Medical Washer

1. Assess Classification: Confirm your Medical Washer is Class B per the latest notification.

2. Initiate Test License Application: Prepare and submit Form MD13 for test license via the CDSCO portal.

3. Plan Product Testing: Schedule testing at government-approved labs early.

4. Compile Documentation: Gather all required documents including Device and Plant Master Files.

5. Select Notified Body: Identify and communicate with an approved auditor.

6. Submit Manufacturing License Application: File Form MD3 for the MD5 license online.

7. Prepare for Audit: Ensure compliance and readiness for the notified body’s inspection.

8. Respond to Queries: Maintain prompt communication with CDSCO and auditors.

By following these practical steps and leveraging expert guidance, you can confidently navigate the CDSCO licensing pathway and bring your Medical Washer to the Indian market efficiently and compliantly.