CDSCO License for Home faecal specimen collection kit

Introduction to Home Faecal Specimen Collection Kit and Regulatory Importance

The Home Faecal Specimen Collection Kit is a Class A medical device designed for laypersons to collect and send stool samples to clinical laboratories for diagnostic screening such as occult blood or cytology tests. Given its non-sterile nature and use in urology diagnostics, this device falls under the lowest risk category but still requires stringent regulatory compliance to ensure safety and efficacy.

Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process is critical for manufacturers and importers aiming to launch this device in the Indian market. With over 25 years of experience and having assisted 500+ companies, we understand the nuances of securing timely approvals and maintaining compliance.

CDSCO Regulatory Framework for Home Faecal Specimen Collection Kit

The CDSCO regulates medical devices under the Medical Devices Rules, 2017. Home Faecal Specimen Collection Kits are classified as Class A devices due to their non-invasive nature and minimal risk to users. The licensing authority for Class A devices is the State Licensing Authority, and the applicable manufacturing license form is MD5.

Our guidance ensures you meet all regulatory expectations, including compliance with the device-specific notification File No. 29/Misc./03/2020-DC (145) dated 23.8.2021.

Risk Classification and License Requirements

• Risk Class: A (Low risk)
• License Type: Manufacturing license MD5 (Application Form MD3)
• Authority: State Licensing Authority
• Regulatory Notifications: Ensure adherence to the specific CDSCO notification dated 23.8.2021

Class A devices require a simpler regulatory route compared to higher classes but still demand comprehensive documentation and an audit by a notified body.

Manufacturing License Process (MD5) for Home Faecal Specimen Collection Kit

1. Test License Application: Begin by obtaining a Test License on Form MD13, valid typically for 1.5 to 2 months. This permits you to manufacture the device for testing purposes.
2. Product Testing: Submit the device samples to CDSCO-approved testing laboratories for quality and safety evaluation. Access the list of approved testing labs to select an appropriate facility.
3. Document Preparation: Compile all required regulatory documents including Device Master File, Plant Master File, and Risk Management File.
4. License Application on Form MD3: Submit your complete application for the manufacturing license MD5 via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body authorized by CDSCO will conduct an audit of your manufacturing site and quality systems. Refer to the Notified Bodies list to engage the right auditor.
6. Query Resolution: Respond promptly to any queries raised by the licensing authority or notified body to avoid delays.
7. Grant of License: Upon satisfactory review and audit, the license on Form MD5 will be granted.

The entire process generally takes 3 to 4 months, contingent on timely testing and audit completion.

Manufacturing License Documents Required for Home Faecal Specimen Collection Kit

Prepare the following key documents to ensure a smooth application process:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details of Technical Staff with qualifications
• Fire and Pollution NOCs
• Device Master File detailing device specifications, design, and manufacturing processes (Guide here)
• Plant Master File outlining the manufacturing facility (Guide here)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File demonstrating hazard identification and mitigation (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Home Faecal Specimen Collection Kit

For importers intending to bring the kit into India, an MD15 Import License is required from the Central Licensing Authority. The process includes:

• Comprehensive document preparation including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device and Plant Master Files
• Submission of application on Form MD14 via the CDSCO MD Online Portal
• Resolution of departmental queries
• License grant in approximately 5 to 6 months

Note that for Class A devices, government fees are relatively lower, but strict adherence to documentation is essential.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate ensuring device can be legally sold in exporting country
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate, if device is CE marked
• Device Master File and Plant Master File
• Wholesale license in India, if applicable
• Company Constitution

Timeline and Processing Duration

Import license processing typically takes 5 to 6 months due to central authority involvement.

Government Fees and Costs

• MD5 Manufacturing License:

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

• MD15 Import License for Class A Devices:

  • Site Fee: Approximately $1,000 per site
  • Per Product Fee: Around $50

Additional costs include fees for testing at approved laboratories, audit charges by notified bodies, and preparation of quality documentation.

Common Challenges and Solutions

• Delayed Test Reports: Selecting reliable and CDSCO-approved testing labs early can mitigate delays. Use the Testing Laboratories list to identify dependable facilities.

• Audit Non-Conformities: Detailed pre-audit internal checks against notified body criteria reduce adverse findings. Utilize checklists from notified bodies and consult our MD5 License Guide for preparation.

• Incomplete Documentation: Document gaps cause frequent query rounds. Employ experienced consultants to review your Device and Plant Master Files and QMS documents before submission.

• Regulatory Updates: Stay updated with CDSCO notifications relevant to your device category to ensure compliance.

Expert Consultation and Support

Our team has successfully guided over 500 companies through CDSCO licensing for Class A devices like the Home Faecal Specimen Collection Kit. We offer end-to-end support from document preparation, audit readiness, test lab coordination, to application filing and query management.

Leveraging our expertise can reduce approval timelines and avoid costly rejections or compliance issues.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device as Class A based on CDSCO guidelines (Medical Device Classification).
2. Initiate Test License Application: File Form MD13 on the CDSCO MD Online Portal to start manufacturing for testing.
3. Select Testing Laboratory: Choose a government-approved lab early to schedule timely testing.
4. Prepare Documentation: Compile and review all required technical and quality files.
5. Schedule Audit: Engage a notified body from the official list to plan your site audit.
6. Submit MD5 License Application: Once testing and audit are complete, apply for the manufacturing license using Form MD3.
7. Respond to Queries Promptly: Maintain open communication with CDSCO officials and auditors.

By following this roadmap and leveraging expert guidance, manufacturers and importers can efficiently secure their CDSCO license to bring the Home Faecal Specimen Collection Kit to the Indian market, ensuring compliance and market success.