CDSCO License for Washers for body waste receptacles.

Introduction to Washers for Body Waste Receptacles and Their Regulatory Importance

Washers for body waste receptacles, such as bedpans, play a crucial role in healthcare settings by ensuring effective cleaning and sanitization of these medical devices. Classified under General Hospital or Orthopaedic Instruments, these washers are essential for infection control and patient safety. Given their medical application, compliance with Indian regulatory standards is mandatory before manufacturing or marketing.

The Central Drugs Standard Control Organization (CDSCO) regulates these devices under the Medical Device Rules (MDR) 2017, ensuring safety, quality, and efficacy. For manufacturers and importers of Class A devices like washers for body waste receptacles, obtaining a valid manufacturing or import license from CDSCO is a critical step to legally operate in India.

CDSCO Regulatory Framework for Washers for Body Waste Receptacles

Our 25+ years of experience in medical device regulatory affairs confirms that these washers fall under Class A (low risk) medical devices as per the MDR 2017 notification [29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022]. Class A devices are regulated by the State Licensing Authority, streamlining the licensing process compared to higher risk classes.

The regulatory framework mandates:

• Obtaining a Test License (MD13) prior to manufacturing
• Product testing at government-approved laboratories
• Submission of comprehensive documentation including Device Master File and Plant Master File
• Successful audit by a notified body
• Final grant of Manufacturing License (MD5) for Class A devices

Risk Classification and License Requirements

Washers for body waste receptacles are categorized as Class A devices, which means:

• License Type: MD5 Manufacturing License
• Authority: State Licensing Authority
• Application Form: MD3 for license application
• Process Duration: Approximately 3-4 months including test license and audit
• Fees: Rs. 5000 per application + Rs. 500 per product

You can verify classification details on the Medical Device Classification guide.

Manufacturing License Process (MD5) for Class A Devices

1. Apply for Test License (Form MD13): Initiate the process by applying for a Test License on Form MD13 via the CDSCO MD Online Portal. This license allows you to manufacture the device solely for testing purposes. Processing takes approximately 1.5 to 2 months.

2. Product Testing: Get your washers tested at any of the CDSCO-approved government testing laboratories. Select a lab from the Testing Laboratories list to conduct the required performance and safety evaluations.

3. Document Preparation: Prepare detailed documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, Quality Management System (QMS) documents, and product labels.

4. Submit MD5 License Application (Form MD3): Post testing, submit your manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: After application submission, a notified body will conduct an on-site audit to verify compliance with manufacturing and quality standards. Choose your notified body from the Notified Bodies list.

6. Queries and Clarifications: Respond promptly to any queries raised by the department or notified body during the review process.

7. Grant of MD5 License: Upon satisfactory compliance, the State Licensing Authority will grant the MD5 manufacturing license.

For a detailed stepwise guide, refer to our MD5 License Guide.

Manufacturing License Documents Required for Washers

To ensure a smooth application process, prepare the following documents meticulously:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing design, specifications, and manufacturing process (See our Device Master File Guide)
• Plant Master File describing manufacturing facilities and equipment (Refer to our Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File implementing risk analysis and mitigation strategies (Learn more on Risk Management)
• Test Reports from government-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification is recommended)

Import License Process (MD15) for Washers for Body Waste Receptacles

Although your device falls under Class A and primarily requires a manufacturing license, importers must secure an MD15 import license from the Central Licensing Authority.

• Application Form: MD14
• Timeline: Approximately 5-6 months
• Documents: Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
• Fees: Based on device class and number of products; for Class A, typically $1000 per site and$50 per product.

For more information, explore our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from exporting country
• Free Sale Certificate ensuring product is permitted for sale abroad
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Detailed Device Master File
• Plant Master File
• Wholesale Drug License
• Company Constitution Documents

Timeline and Processing Duration

Total estimated timeline for MD5 license: 3 to 4 months.

Government Fees and Costs

• Application Fee: Rs. 5000 per manufacturing license application
• Product Fee: Rs. 500 per product
• Audit Fees: Usually included but may vary depending on notified body

Budgeting for product testing and documentation preparation is also essential. Our experience shows that investing in thorough documentation upfront avoids costly delays.

Common Challenges and Solutions

• Delayed Testing Results: Choose reputed government-approved labs and plan testing early.
• Incomplete Documentation: Use our comprehensive checklists to avoid omissions.
• Audit Non-Compliance: Conduct internal audits prior to notified body inspection.
• Query Resolution Delays: Assign dedicated regulatory personnel to respond quickly.

Addressing these challenges proactively ensures timely license approval.

Expert Consultation and Support

With over 500 successful CDSCO license approvals for Class A devices, we provide tailored consultancy, including document preparation, audit readiness, and application submission. Our team stays updated on regulatory changes and negotiates with authorities to expedite approvals.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal: Begin by creating your account on the CDSCO MD Online Portal.

2. Prepare Your Test License Application: Collect all required documents and submit Form MD13.

3. Schedule Product Testing: Select a testing laboratory early to avoid bottlenecks.

4. Develop Your Device and Plant Master Files: Utilize our guides to create comprehensive files.

5. Plan Your QMS and Risk Management Documentation: Implement ISO 13485 and risk management protocols.

6. Engage with a Notified Body: Identify and liaise with a notified body from the official list for your audit.

7. Submit Your MD5 Application: Once testing and documentation are complete, apply for the manufacturing license.

Taking these practical steps will streamline your path to CDSCO compliance and market entry. Contact us to leverage our expertise and ensure success in obtaining your MD5 license for washers for body waste receptacles.