CDSCO License for Intramuscular diaphragm/phreni c nerve electrical stimulation system programmer
Medical Device Information
Intended Use
Intended to change, telemetrically, one or more of the operating parameters (the programs) of an intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator (EPG).
Comprehensive Guide to CDSCO Licensing for Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System Programmer (Class C)
Navigating the regulatory landscape for advanced neurological devices like the Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer is critical for manufacturers and importers aiming to enter the Indian medical device market. This device, intended to telemetrically adjust operating parameters of an external pulse generator (EPG), falls under Class C risk category, requiring a stringent regulatory approach under the Central Drugs Standard Control Organization (CDSCO).
With over 25 years of experience and having supported 500+ companies in securing CDSCO approvals, we provide you with a detailed roadmap tailored to this device type, risk class, and intended use.
CDSCO Regulatory Framework for Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System Programmer
This neurological device is regulated under the Medical Device Rules (MDR) 2017, notified vide notification 29/Misc/03/2020-DC (201) dated 27.09.2021. Being a Class C device, it is considered moderate to high risk, and licensing is managed by the Central Licensing Authority (CLA) of CDSCO.
The regulatory framework mandates:
- Compliance with Essential Principles of Safety and Performance
- Submission of detailed technical and quality documentation
- Product testing from government-approved labs
- Comprehensive audits by CDSCO inspectors
The entire process is designed to ensure patient safety and product efficacy, especially for devices involved in neurological stimulation.
Risk Classification and License Requirements
As per the Medical Device Classification by CDSCO, your device is classified as Class C due to its neurological application and invasive function.
License Required: MD9 Manufacturing License (Form MD7)
- Issued by the Central Licensing Authority
- Covers manufacturing of Class C and D devices
- Involves rigorous testing, documentation, and audits
For importers, the MD15 Import License applies, which we'll cover later.
Manufacturing License Process (MD9)
Obtaining an MD9 license for your device involves several sequential steps:
Test License (Form MD13): Before the manufacturing license application, you must obtain a Test License allowing you to manufacture the device for testing purposes. This step takes approximately 1.5 to 2 months.
Product Testing: Conduct testing at CDSCO-approved government labs to validate compliance with safety and performance standards. Refer to the Testing Laboratories list to select an authorized lab.
Document Preparation: Compile a comprehensive dossier including technical files, quality management system (QMS) documentation, Device Master File (DMF), and Plant Master File (PMF).
Application Submission: Apply for the MD9 license using Form MD7 through the CDSCO MD Online Portal.
Audit: CDSCO inspectors will perform a detailed audit of your manufacturing facility, QMS, and documentation.
Query Resolution: Respond promptly to any observations or queries raised by CDSCO or auditors.
License Grant: Upon satisfactory compliance, CDSCO issues the MD9 license (Form MD9), authorizing manufacturing.
For detailed guidance, please review our dedicated MD9 License Guide.
Manufacturing License Documents Required for MD9
To streamline your application, prepare the following documents meticulously:
- Company Constitution: Certificate of incorporation, Memorandum and Articles of Association
- Proof of Ownership/Lease of Premises: Valid property documents
- Technical Staff Details: Qualification and experience certificates of key personnel
- Fire NOC & Pollution Control NOC: To comply with environmental and safety regulations
- Device Master File (DMF): Comprehensive device specifications, design, manufacturing process, and validation. Learn more via our Device Master File guide
- Plant Master File (PMF): Details of manufacturing facilities, equipment, and quality control systems. See our Plant Master File Guide
- Essential Principles Compliance Checklist: Demonstrating adherence to CDSCO safety and performance standards
- Risk Management File: Addressing risk identification, assessment, and mitigation strategies as per ISO 14971. Refer to our Risk Management resource
- Test Reports: From government approved labs
- Labels and Instructions For Use (IFU): Clearly specifying device use and safety instructions
- Quality Management System Documents: ISO 13485 certification and internal SOPs
It is crucial to ensure accuracy and completeness to avoid delays.
Import License Process (MD15)
If you are an importer of this device, the process differs:
- No Test License Required: Unlike manufacturing, you do not need an MD13 test license.
- Application: Submit Form MD14 for the MD15 import license via the CDSCO portal.
- Documentation: Provide manufacturing licenses from the country of origin, Free Sale Certificates, ISO 13485:2016 certification, CE certificate if applicable, and your company constitution.
- Review and Queries: CDSCO reviews documents and may raise queries.
- Grant of License: Upon satisfactory assessment, the MD15 license is issued.
Refer to our detailed Import License Guide for a step-by-step process.
Import License Documents Required for MD15
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution and Proof of Establishment
- Product Labels and IFU
Timeline and Processing Duration
| License Type | Process Steps | Approximate Duration |
|---|---|---|
| MD9 (Manufacturing) | Test License + Testing + Application + Audit + Query Resolution | 4-5 months |
| MD15 (Import) | Document Preparation + Application + Query Resolution + Grant | 5-6 months |
The test license step for manufacturing typically takes 1.5-2 months, followed by product testing. The audit and query resolution phases are crucial and may extend the timeline if documentation is incomplete.
Government Fees and Costs
For your Class C device, the fee structure is as follows:
MD9 Manufacturing License:
- Application Fee: Rs. 50,000
- Per Product Fee: Rs. 1,000
MD15 Import License:
- Site Fee: $3,000 (approximately Rs. 2.4 Lakhs)
- Per Product Fee: $1,500 (approximately Rs. 1.2 Lakhs)
Additional costs include:
- Testing laboratory charges (varies by lab and tests)
- Notified body audit fees
- Consultancy fees if you opt for expert regulatory support
Common Challenges and Solutions
1. Incomplete Documentation: Missing or inconsistent documents are the leading cause of delays.
Solution: Use detailed checklists and cross-verify all files before submission.
2. Delayed Testing: Government labs often have backlogs.
Solution: Schedule testing early and consider multiple labs from the approved list.
3. Audit Non-Compliance: Facility or QMS deficiencies can lead to non-approval.
Solution: Conduct internal audits and mock inspections to prepare.
4. Query Resolution Delays: Slow responses increase processing time.
Solution: Maintain a dedicated regulatory team for prompt replies.
Expert Consultation and Support
Given the complexity of Class C device approvals, partnering with experienced consultants can significantly reduce risks and expedite approvals. We offer:
- Tailored regulatory strategy
- Documentation drafting and review
- Liaison with CDSCO and notified bodies
- Audit preparation and support
- Post-approval compliance guidance
Our proven track record with over 500 successful CDSCO licenses speaks to our commitment and expertise.
Getting Started with Your CDSCO License Application
To kick-start your CDSCO MD9 license process for the Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer, follow these practical steps:
Register on the CDSCO MD Online Portal: Ensure your organization is properly registered.
Initiate Test License Application (Form MD13): Prepare and submit your application to commence manufacturing for testing.
Identify Testing Laboratories: Contact approved labs early to schedule testing slots.
Prepare Documentation: Begin assembling your DMF, PMF, risk management, and QMS documents concurrently.
Engage a Notified Body: Select an accredited notified body from the list here for the mandatory audit.
Plan for Audit: Conduct a gap analysis and internal pre-audit.
Submit MD9 Application: Once testing and document preparation are complete, apply on the portal.
Respond to Queries Promptly: Ensure swift communication with CDSCO to avoid delays.
By following this roadmap and leveraging expert guidance, your journey toward CDSCO approval will be efficient and compliant.
For personalized assistance or detailed consultancy, reach out to our regulatory experts who have been pivotal in enabling medical device market access across India for over two decades.
Embark on your regulatory journey with confidence and ensure your innovative neurological device reaches patients safely and compliantly.
