CDSCO License for Sitz bath chair

Comprehensive Guide to CDSCO Licensing for Sitz Bath Chair (Class A Medical Device)

The Sitz Bath Chair is a specialized medical device designed to facilitate powered sitz baths for external hydrotherapy. It aids in relieving pain or itching and promotes healing of inflamed or traumatized tissues in the perianal and perineal areas. As a Class A device under CDSCO's medical device classification, it falls under the lowest risk category, but compliance with regulatory requirements remains critical for market entry in India.

With over 25 years of experience helping more than 500 companies successfully obtain CDSCO licenses, we understand the nuances manufacturers and importers face. This guide provides a step-by-step pathway tailored specifically for the Sitz Bath Chair, focusing on CDSCO’s MD5 licensing process.

CDSCO Regulatory Framework for Sitz Bath Chair

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. The Sitz Bath Chair is notified under File No. 29/Misc./03/2020-DC (178) dated 13.9.2021, classified as a Class A device, which means it is considered low risk. This classification determines the licensing authority, documentation, and timelines.

All manufacturers must obtain a manufacturing license (MD5) from the State Licensing Authority before selling or distributing the device in India. For importers, an import license (MD15) issued by the Central Licensing Authority is mandatory.

Risk Classification and License Requirements for Sitz Bath Chair

• Device Name: Sitz Bath Chair
• Risk Class: A (Low Risk)
• Intended Use: External hydrotherapy for pain relief and accelerated healing in perianal/perineal areas
• License Type: MD5 Manufacturing License
• Licensing Authority: State Licensing Authority

Manufacturing License Process (MD5) for Sitz Bath Chair

The MD5 license process involves multiple stages:

1. Apply for Test License (Form MD13): Before full manufacturing license application, a test license must be obtained. This allows product testing in government-approved labs.

2. Product Testing: Submit Sitz Bath Chair samples to CDSCO-approved testing laboratories for evaluation.

3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and others.

4. Application Submission: Submit the application for MD5 license using Form MD3 through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will audit your manufacturing site and quality systems. Refer to the list of notified bodies for authorized entities.

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

7. License Grant: Upon successful compliance, the MD5 manufacturing license will be issued.

Manufacturing License Documents Required for Sitz Bath Chair

To ensure a smooth application, prepare the following documents:

• Company Constitution/Registration Certificate
• Proof of Ownership/Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC (if applicable)
• Device Master File (DMF) detailing design and specifications (Device Master File Guide)
• Plant Master File describing manufacturing facilities and processes (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File according to ISO 14971 standards (Risk Management)
• Test Reports from CDSCO-recognized laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485 certificates)

Import License Process (MD15) for Sitz Bath Chair

If you are an importer of Sitz Bath Chairs, the MD15 import license is required, which is granted by the Central Licensing Authority.

Key steps include:

• Preparation of import-specific documents such as Free Sale Certificate, CE Certificate, and existing manufacturing license.
• Submission of application via Form MD14 on the CDSCO MD Online Portal.
• Resolution of any queries from CDSCO.
• Receipt of MD15 import license.

Note: For Class A devices like the Sitz Bath Chair, the import license process takes approximately 5-6 months.

Import License Documents Required

• Valid Manufacturing License
• Free Sale Certificate from country of origin
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution/Registration Certificate

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months from start to finish for MD5 license.

Government Fees and Costs

For the Sitz Bath Chair (Class A device), the fees are:

• Test License (MD13): Included in application costs
• Manufacturing License (MD5): Rs. 5000 per application
• Product Fee: Rs. 500 per product

Additional costs may include:

• Notified body audit fees (varies by auditor)
• Testing laboratory charges (dependent on tests required)

Common Challenges and Solutions

Challenge: Delays in product testing due to incomplete samples or documentation.

Solution: Prepare samples according to CDSCO specifications and ensure complete documentation accompanies submissions.

Challenge: Queries raised by the notified body during audit related to QMS compliance.

Solution: Implement a robust Quality Management System aligned with ISO 13485 before audit.

Challenge: Lack of clarity on documentation requirements leading to multiple submissions.

Solution: Engage an experienced regulatory consultant to pre-validate documents and application.

Expert Consultation and Support

Our team has guided over 500 manufacturers and importers through the CDSCO licensing maze. We provide:

• Pre-assessment of your product and facility
• Complete documentation preparation support
• Coordination with notified bodies and testing labs
• End-to-end application submission and follow-up

Partnering with us reduces approval timelines and ensures compliance with minimal hassle.

Getting Started with Your CDSCO License Application for Sitz Bath Chair

1. Assess Your Device Classification: Confirm Sitz Bath Chair as Class A under Medical Device Classification.

2. Create an Account on CDSCO MD Online Portal: Register at the CDSCO MD Online Portal to initiate your application.

3. Prepare Test License Application (Form MD13): Submit for approval to begin product testing.

4. Engage with Approved Testing Laboratories: Utilize the Testing Laboratories list to select a lab.

5. Compile Required Documentation: Use our guides for Device Master File and Plant Master File to organize documents.

6. Schedule and Prepare for Notified Body Audit: Refer to the list of notified bodies and prepare your facility accordingly.

7. Submit MD5 License Application (Form MD3): Once testing and audit are complete, file your manufacturing license application.

With meticulous preparation and expert guidance, you can achieve timely approval and confidently launch your Sitz Bath Chair in the Indian market. Contact us today to streamline your CDSCO licensing journey.