CDSCO License for Analytical non- scalp cutaneous lead
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
Intended to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance].
Comprehensive Guide to CDSCO Licensing for Analytical Non-Scalp Cutaneous Lead (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having supported more than 500 companies in successfully navigating the Indian regulatory landscape, we understand the nuances involved in obtaining CDSCO licenses for specialized devices like the Analytical Non-Scalp Cutaneous Lead. This neurological device, classified as Class A under the CDSCO framework, plays a critical role in electrophysiological monitoring, such as electromyography (EMG) and evoked potentials (EP).
Understanding the Regulatory Importance of the Analytical Non-Scalp Cutaneous Lead
This device is intended to conduct electrical signals between skin or needle electrodes and electrophysiological recording devices. Given its direct interaction with patients’ neurological functions, regulatory compliance ensures safety, efficacy, and quality, which is paramount for manufacturers and importers aiming to enter or expand in the Indian market.
CDSCO Regulatory Framework for Analytical Non-Scalp Cutaneous Lead
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Devices Rules, 2017. The Analytical Non-Scalp Cutaneous Lead falls under the neurological category and is notified under 29/Misc/03/2020-DC (201) dated 27.09.2021. As a Class A device, it is considered low risk but still requires compliance with essential principles and licensing before manufacturing or import.
Risk Classification and License Requirements
- Risk Class: A (Low risk)
- Applicable License: MD5 Manufacturing License (Form MD3)
- Licensing Authority: State Licensing Authority
- Process Duration: Approximately 3 to 4 months
Refer to Medical Device Classification for detailed insights.
Manufacturing License Process for Analytical Non-Scalp Cutaneous Lead (MD5 License)
The manufacturing license process for Class A devices involves several well-defined steps:
- Test License (Form MD13): Obtain a test license from the State Licensing Authority. This takes about 1.5 to 2 months and allows batch-wise manufacturing for testing purposes.
- Product Testing: Conduct product testing at CDSCO-recognized laboratories to validate compliance. You can find the list of approved labs on the Testing Laboratories portal.
- Document Preparation: Prepare comprehensive documentation, including Device Master File and Plant Master File.
- License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: A mandatory audit by an authorized notified body to assess compliance. Check the list of notified bodies for options.
- Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
- Grant of License (Form MD5): Upon satisfactory evaluation, the license is granted.
For a detailed step-by-step approach, our MD5 License Guide offers expert insights.
Manufacturing License Documents Required
To ensure a smooth approval process, prepare the following documents meticulously:
- Constitution of the company/partnership deed
- Proof of ownership or lease agreement of the manufacturing premises
- Qualification and experience certificates of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File detailing design, materials, manufacturing process (refer to our Device Master File guide)
- Plant Master File outlining manufacturing facility and quality control systems (see Plant Master File Guide)
- Essential Principles Checklist as per CDSCO requirements
- Risk Management File demonstrating risk assessment and mitigation (explore best practices in Risk Management)
- Product test reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) compliant with Indian regulations
- Quality Management System (QMS) documents, preferably ISO 13485 certified
Import License Process for Analytical Non-Scalp Cutaneous Lead (MD15 License)
Although this device is Class A and manufacturing license is processed at the state level, importers must apply for the MD15 Import License via the Central Licensing Authority. The process involves:
- Document preparation including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificates, Device and Plant Master Files
- Application submission on the CDSCO MD Online Portal
- Query resolution with the CDSCO department
- License grant within approximately 5 to 6 months
For further details, consult our Import License Guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| License Application (MD5) | 1 month including audit |
| Total Time | Approximately 3 – 4 months |
Government Fees and Costs
- MD5 License Application Fee: ₹5,000 per application
- Fee per Product: ₹500
Note that these fees are exclusive of costs related to testing, auditing, and consultancy.
Common Challenges and Practical Solutions
- Delays in Documentation: Ensure early preparation of Device and Plant Master Files; using professional templates can expedite this.
- Audit Non-compliance: Pre-audit internal checks help identify gaps before notified body inspections.
- Testing Delays: Book slots early at approved labs and maintain clear communication.
- Query Resolution: Assign a dedicated regulatory officer to respond promptly and comprehensively to CDSCO queries.
Expert Consultation and Support
Our vast experience in assisting over 500 companies means we offer tailored solutions for your device’s regulatory journey. From document preparation to audit readiness and post-approval compliance, our expert team guides you at every step to minimize delays and ensure success.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm your device’s Class A status via online resources.
- Prepare Test License Application: Gather required documents and submit Form MD13 through the CDSCO MD Online Portal.
- Schedule Product Testing: Coordinate with CDSCO-approved labs early.
- Develop Master Files: Utilize our Device Master File guide and Plant Master File Guide to craft compliant documentation.
- Engage Notified Body: Identify and initiate contact with a notified body for audits.
- Submit Manufacturing License Application: Complete and file Form MD3 online once testing and documentation are in place.
Embarking on this pathway with a clear roadmap significantly improves your chances of timely approval and market entry. Connect with us to leverage our regulatory expertise and streamline your CDSCO licensing journey for the Analytical Non-Scalp Cutaneous Lead.
