CDSCO License for Hollow-fibre haemodialysis dialyser
Medical Device Information
Intended Use
Hollow fiber filter intended to remove impurities/fluid from the blood of a patient via haemodialysis machine.
Introduction to Hollow-Fibre Haemodialysis Dialyser and Regulatory Importance
The Hollow-fibre haemodialysis dialyser is a critical nephrology medical device designed to filter impurities and excess fluids from the blood through a haemodialysis machine. Given its direct contact with bloodstream and life-sustaining function, this device is classified as a Class C medical device under the Indian CDSCO regulatory framework. Compliance with CDSCO licensing is not only mandatory for legal marketing in India but also ensures patient safety, quality assurance, and market credibility.
With over 25 years of experience assisting more than 500 manufacturers and importers, we understand the nuances of navigating the CDSCO licensing process for such high-risk devices. This comprehensive guide will walk you through the regulatory framework, application procedures, document requirements, timelines, fees, and expert tips tailored specifically for Hollow-fibre haemodialysis dialysers.
CDSCO Regulatory Framework for Hollow-Fibre Haemodialysis Dialyser
The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. Hollow-fibre haemodialysis dialysers fall under Class C as per Notification 29/Misc./03/2020-DC (143) dated 13.9.2021, which places them under medium-high risk categories.
Due to their risk profile, these devices require a centralized regulatory approval process led by the CDSCO Central Licensing Authority. The key licenses are:
- MD9 Manufacturing License: For domestic manufacturing.
- MD15 Import License: For importers seeking to bring these devices into India.
Manufacturing also requires prior approval of a test license (MD13) and product testing from CDSCO-approved laboratories.
Risk Classification and License Requirements
| Risk Class | Device Category | License Type | Licensing Authority | Approximate Timeline | Fees (INR) |
|---|---|---|---|---|---|
| Class C | Hollow-fibre haemodialysis dialyser | MD9 | CDSCO Central Licensing | 4-5 months | ₹50,000 + ₹1,000 per product |
| Class C | Import of same device | MD15 | CDSCO Central Licensing | 5-6 months | ₹2,25,000 per site + ₹1,50,000 per product (USD equivalent) |
It is critical to understand that the MD9 manufacturing license process involves multiple stages: test license issuance, product testing, documentation, audit, and final approval.
Manufacturing License Process (MD9)
- Test License (MD13) Application: Submit Form MD13 for test license to manufacture samples for testing.
- Product Testing: Get the device tested at CDSCO-recognized laboratories such as those listed on the CDSCO Testing Laboratories portal.
- Documentation Preparation: Prepare complete dossiers including Device Master File and Plant Master File.
- MD9 Application Submission: Apply through the CDSCO MD Online Portal using Form MD7.
- CDSCO Audit: Facilitate inspection by CDSCO officials.
- Query Resolution: Address any queries or deficiencies highlighted.
- License Grant: Upon successful compliance, the MD9 license is issued.
Manufacturing License Documents Required
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualification Proofs of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) (Refer our detailed Device Master File guide)
- Plant Master File (PMF) (See our Plant Master File guide)
- Essential Principles Checklist
- Risk Management File (Refer to Risk Management)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation, preferably ISO 13485:2016 certification
Import License Process (MD15)
- Document Compilation: Assemble all mandatory import documents.
- Application Submission: File Form MD14 for import license via CDSCO MD Online Portal.
- Review and Queries: Respond promptly to CDSCO queries.
- Approval and Grant: Upon satisfactory review, the MD15 import license is granted.
Importers must ensure compliance with quality standards, possessing valid manufacturing licenses from the country of origin, and certifications like CE marking.
Import License Documents Required
- Valid Manufacturing License of the product from the country of origin
- Free Sale Certificate (FSC) from the country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent international certifications
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution and Incorporation Documents
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| MD13 Test License | 1.5 to 2 months |
| MD9 Manufacturing | 4 to 5 months (including test license) |
| MD15 Import License | 5 to 6 months |
Understanding these timelines enables manufacturers and importers to plan product launches and inventory management effectively.
Government Fees and Costs
- MD9 Manufacturing License: ₹50,000 per application + ₹1,000 per product.
- MD13 Test License: Included within MD9 process, no separate fee.
- MD15 Import License: Differentiated by device class; Class C devices typically incur ₹3,00,000 per site + ₹1,50,000 per product (approx USD equivalents).
Budgeting for these fees upfront avoids surprises during application.
Common Challenges and Solutions
- Delays in Test Reports: Engage early with CDSCO-approved labs to schedule timely testing.
- Incomplete Documentation: Use comprehensive checklists such as those provided in our MD9 License Guide to avoid deficiencies.
- Audit Non-Compliance: Prepare rigorously for CDSCO inspections; maintain a well-documented QMS.
- Query Resolution Delays: Respond promptly and thoroughly to CDSCO queries to prevent processing delays.
Manufacturers have found that investing time upfront in quality documentation and proactive communication significantly improves approval timelines.
Expert Consultation and Support
Given the complexity of the MD9 and MD15 licensing processes, our expert team offers end-to-end support including dossier preparation, liaison with CDSCO, audit readiness, and post-approval compliance. We have successfully guided over 500 companies through CDSCO licensing, helping them minimize risks and accelerate market entry.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Double-check your device’s risk class and regulatory pathway on the Medical Device Classification resource.
- Prepare Test License Application: Begin by submitting Form MD13 for test license.
- Coordinate Product Testing: Schedule testing at CDSCO-recognized labs early to avoid delays.
- Compile Comprehensive Documentation: Leverage our guides on Device Master File, Plant Master File, and Risk Management.
- Apply Online: Submit your MD9 manufacturing or MD15 import license application through the CDSCO MD Online Portal.
- Engage with Notified Bodies: For audit readiness, consult the list of notified bodies.
- Plan for Queries and Inspection: Allocate resources for timely responses and compliance.
Starting early with expert guidance ensures a smooth approval journey for your Hollow-fibre haemodialysis dialyser, enabling you to bring this vital device to the Indian market efficiently and compliantly.
