CDSCO License for Implanted diaphragmatic/ph renic nerve stimulator.
Medical Device Information
Intended Use
An implanted diaphragmatic/phrenic nerve stimulator is a device that provides electrical stimulation of a patient's phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver
Comprehensive Guide to CDSCO Licensing for Implanted Diaphragmatic/Phrenic Nerve Stimulator (Class D Neurological Device)
As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ medical device companies, we understand the complexities involved in securing a CDSCO license for high-risk medical devices like the Implanted Diaphragmatic/Phrenic Nerve Stimulator. This device plays a critical role in managing hypoventilation by electrically stimulating the phrenic nerve to restore diaphragm movement, classified as Class D due to its invasive nature and direct physiological impact.
CDSCO Regulatory Framework for Implanted Diaphragmatic/Phrenic Nerve Stimulator
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India under the Medical Device Rules (MDR) 2017. The Implanted Diaphragmatic/Phrenic Nerve Stimulator is categorized under Neuro devices and falls under Class D — the highest risk class — requiring the most stringent regulatory scrutiny.
Risk Classification and License Requirements for Class D Devices
According to the CDSCO classification, Class D devices pose significant risk to patients and require a Central Licensing Authority (CLA) approval. The license for manufacturing is the MD9 License (using Application Form MD7), and for imports, the MD15 License is applicable. Considering the complexity and critical nature of this device, the MD9 license process includes rigorous testing, documentation, and inspections.
More information on medical device classification can provide clarity for related devices.
Manufacturing License Process (MD9) for Implanted Diaphragmatic/Phrenic Nerve Stimulator
The MD9 manufacturing license application is submitted to the Central Licensing Authority via the CDSCO MD Online Portal. The process generally follows these stages:
- Test License (MD13) Application: Initially, a test license is mandatory for Class C & D devices, taking approximately 1.5 to 2 months. This allows sample testing of the device.
- Product Testing: Testing must be conducted at CDSCO-approved laboratories (list of testing labs) to verify compliance with essential performance and safety standards.
- Document Preparation: This phase involves compiling comprehensive documentation, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
- License Application Submission (Form MD7): Upon successful testing, the complete application is submitted.
- Audit by CDSCO Inspectors: CDSCO conducts a detailed audit of the manufacturing premises and QMS.
- Query Resolution: Addressing any observations or queries raised during audit or document review.
- Grant of MD9 License: Final issuance of the manufacturing license on Form MD9.
Manufacturing License Documents Required for MD9
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Qualifications and Experience of Technical and Quality Staff
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed device description, design, and specifications (Device Master File Guide)
- Plant Master File (PMF): Manufacturing processes, quality control measures (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File: Evidence of risk analysis and mitigation strategies (Risk Management)
- Product Testing Reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU) in compliance with Indian regulations
- Quality Management System documentation (ISO 13485:2016 certification is highly recommended)
Import License Process (MD15) for Implanted Diaphragmatic/Phrenic Nerve Stimulator
If your organization intends to import this Class D stimulator, the MD15 import license from the Central Licensing Authority is mandatory. Unlike manufacturing, a test license is not required here, but the process remains rigorous:
- Document Preparation including manufacturing license from the country of origin, Free Sale Certificate, CE certificate (if applicable), ISO 13485:2016, Device and Plant Master Files.
- Application Submission on Form MD14 via the CDSCO MD Online Portal.
- Review and Query Resolution by CDSCO officials.
- Grant of MD15 Import License.
Documents required include:
- Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License for distribution (if applicable)
- Company Constitution and Address Proof
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation & Application | 1 month |
| CDSCO Inspection and Audit | 1 month |
| Query Resolution | 1 month |
| Total Time for MD9 License | 4 to 5 months |
| Total Time for MD15 Import License | 5 to 6 months |
Government Fees and Costs
| License Type | Fee Structure |
|---|---|
| MD9 Manufacturing | Rs. 50,000 per application + Rs. 1,000 per product |
| MD15 Import | Class D: 1,500 per product (approx. Rs. 2.5 lakhs + product fees) |
Additional costs include fees for testing at government-approved labs, audit charges, and consultancy fees if applicable.
Common Challenges and Solutions
- Complex Documentation: Many manufacturers struggle with preparing exhaustive Device and Plant Master Files. Utilizing detailed guides and templates can streamline this task.
- Testing Delays: Testing backlogs at CDSCO-approved labs can extend timelines. Early sample submission and pre-testing at accredited private labs may mitigate delays.
- Audit Non-compliance: Lack of robust QMS and incomplete records often result in audit observations. Prior internal audits and staff training are essential.
- Query Management: Delayed response to CDSCO queries can stall application processing. Assign dedicated regulatory personnel for timely communication.
Expert Consultation and Support
With over 25 years of specialized expertise, our consultancy has successfully navigated the CDSCO regulatory landscape for Class D neurological devices, including implanted nerve stimulators. We assist manufacturers and importers with:
- Gap analysis and readiness assessment
- Preparation of DMF, PMF, Risk Management, and QMS documentation
- Liaison with notified bodies and CDSCO inspectors
- Regulatory submissions and timely query resolution
- Strategic planning for streamlined approvals
Contact us to leverage our proven track record in expediting your CDSCO approvals.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification and Licensing Needs: For the Implanted Diaphragmatic/Phrenic Nerve Stimulator, prepare to apply for an MD9 manufacturing license or MD15 import license.
- Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the application interface.
- Initiate Test License Application (MD13): Begin with the test license, submitting product samples for government lab testing.
- Compile Required Documentation: Use expert resources to build comprehensive DMF and PMF, ensuring all technical and quality documents meet CDSCO standards.
- Engage a Notified Body or prepare for CDSCO Inspection: Coordinate audits by accredited notified bodies or CDSCO inspectors.
- Submit License Application (MD7 for MD9 License): After testing and audits, submit your manufacturing license application.
- Respond Promptly to Queries: Maintain active communication with CDSCO to expedite the approval process.
Embarking on this regulatory journey with a clear roadmap and expert support ensures a smoother path to market entry for your implanted diaphragmatic/phrenic nerve stimulator in India.
For comprehensive insights and assistance, explore our detailed MD9 License Guide and connect with our team today.
