CDSCO License for Dialysis apheresis unit, Therapeutic
Medical Device Information
Intended Use
Intended to filtrates the blood and separates the plasma, and extracts specific substances in the plasma (e.g., LDL-cholesterol). Then, the plasma is passed through the filtration column in the device and the specific substances that are combined with various substrates are extracted.
Comprehensive Guide to CDSCO Licensing for Dialysis Apheresis Unit (Therapeutic) – Class C Medical Device
Dialysis apheresis units play a critical role in nephrology and renal care by filtrating blood, separating plasma, and extracting targeted substances such as LDL-cholesterol. Given their complex mechanism and therapeutic importance, these devices are classified as Class C under the CDSCO regulatory framework, necessitating stringent licensing procedures to ensure safety and efficacy in the Indian market.
With over 25 years of experience and having assisted 500+ companies in obtaining CDSCO licenses, we provide you with an expert, practical roadmap to successfully navigate the regulatory landscape for your dialysis apheresis unit.
CDSCO Regulatory Framework for Dialysis Apheresis Units
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. The regulatory pathway depends on the device’s risk classification. As per CDSCO medical device classification, dialysis apheresis units fall under Class C – a moderate to high risk category requiring rigorous assessment, testing, and audits.
This classification mandates obtaining an MD9 manufacturing license for Indian manufacturers or an MD15 import license for importers, both issued by the Central Licensing Authority.
Notification Reference
- Notification No.: 29/Misc./03/2020-DC (143)
- Date of Notification: 13.09.2021
This notification specifically covers the regulatory requirements for your device.
Risk Classification and License Requirements for Dialysis Apheresis Units
Class C devices like dialysis apheresis units are categorized as moderate to high risk due to their interaction with blood and potential impact on patient safety.
License Types:
- Manufacture in India: MD9 License (Application Form MD7)
- Import into India: MD15 License (Application Form MD14)
Both routes require comprehensive documentation, product testing from CDSCO-approved laboratories, and audits.
Manufacturing License Process (MD9) for Dialysis Apheresis Units
The MD9 license process is centralized and managed by CDSCO. Here’s a stepwise breakdown:
Test License Application (Form MD13): Before applying for MD9, manufacturers must obtain a test license to produce samples for mandatory testing. This process takes approximately 1.5 to 2 months.
Product Testing: Samples are tested at CDSCO-approved laboratories to confirm compliance with Indian standards. Refer to the list of testing laboratories for authorized facilities.
Document Preparation: Prepare all regulatory documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Application Submission: Submit your MD9 application (Form MD7) via the CDSCO MD Online Portal along with prescribed fees.
Audit by CDSCO Inspectors: An on-site audit evaluates compliance with QMS, manufacturing facilities, and technical capabilities.
Resolution of Queries: Address any observations or queries raised during the audit or document review.
Grant of License: Upon successful completion, CDSCO issues the MD9 license, allowing you to manufacture and market the device in India.
For a detailed walkthrough, consult our MD9 License Guide.
Manufacturing License Documents Required for Dialysis Apheresis Unit
Ensuring your dossier is complete is critical to avoid delays. The following documents are mandatory:
- Company Constitution (e.g., Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, manufacturing process, and specifications (Device Master File Guide)
- Plant Master File (PMF) documenting manufacturing environment and facilities (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with regulatory standards
- Risk Management File demonstrating hazard identification and mitigation (Risk Management)
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents including ISO 13485 certification
Import License Process (MD15) for Dialysis Apheresis Units
Importers must apply for the MD15 license granted by the Central Licensing Authority, which typically takes 5 to 6 months.
Key steps include:
Document Preparation: Gather all necessary documents such as manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device Master File, Plant Master File, and Wholesale License.
Application Submission: Apply via the CDSCO MD Online Portal, filling Form MD14.
Departmental Review: CDSCO reviews the dossier, and queries are communicated.
Resolution of Queries: Submit clarifications promptly to avoid delays.
Grant of Import License: Upon satisfactory review, the MD15 license is issued allowing import and distribution in India.
For detailed insights, see our Import License Guide.
Import License Documents Required
- Valid Manufacturing License (MD9) of the foreign manufacturer
- Free Sale Certificate from country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for import
- Company Constitution
Timeline and Processing Duration
| License Type | Process Steps | Approximate Duration |
|---|---|---|
| MD9 Manufacturing | Test License + Testing + Audit | 4 to 5 months total |
| MD15 Import | Document Review + Approval | 5 to 6 months total |
The timeline includes initial test license issuance (1.5–2 months), testing, audit, query resolution, and final license grant.
Government Fees and Costs
For Class C devices like dialysis apheresis units, the fee structure is as follows:
MD9 Manufacturing License:
- Application fee: Rs 50,000
- Per product fee: Rs 1,000
MD15 Import License:
- Site license fee: USD 3,000
- Per product fee: USD 1,500
Additional costs to budget for include product testing fees at CDSCO-approved labs and audit fees payable to notified bodies.
Common Challenges and Practical Solutions
Incomplete Documentation: Missing or inconsistent documents cause delays. Maintain a detailed checklist and cross-verify all files before submission.
Delayed Testing: Testing labs often have long queues. Engage early with CDSCO-approved labs to schedule tests.
Audit Non-Compliance: Ensure your manufacturing site strictly follows QMS and plant master file standards to pass CDSCO inspections.
Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO queries.
Understanding Technical Requirements: Utilize expert consultation to correctly prepare Device and Plant Master Files.
Expert Consultation and Support
Navigating the CDSCO licensing for Class C devices demands in-depth knowledge and experience. Our team, with 25+ years in regulatory consulting, has successfully supported over 500 companies in obtaining MD9 and MD15 licenses.
We provide:
- Customized gap assessments
- End-to-end document preparation
- Coordination with notified bodies and testing labs
- Audit readiness training
- Timely query resolution assistance
Partner with us to streamline your regulatory journey and ensure timely market access.
Getting Started with Your CDSCO License Application
Identify your license route: Are you manufacturing in India (MD9) or importing (MD15)?
Initiate a test license (MD13) if manufacturing: Apply early to avoid delays.
Engage with a notified body: For audit and certification purposes, refer to the list of notified bodies.
Prepare your Device and Plant Master Files: Use our comprehensive guides to ensure compliance.
Schedule product testing: Contact CDSCO-approved labs well in advance.
Submit your application via the CDSCO MD Online Portal: Keep track of your application status regularly.
Plan for audit and inspection: Ensure your facility and QMS are fully compliant.
Respond promptly to queries: Timely replies prevent unnecessary delays.
Taking these practical steps will facilitate a smoother regulatory process and accelerate your dialysis apheresis unit's entry into the Indian healthcare market.
For personalized assistance and to kickstart your CDSCO licensing journey, contact our expert regulatory consultants today.
