CDSCO License for Gait analysis system
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 be used to study walking or running patterns.
Comprehensive Guide to CDSCO Licensing for Gait Analysis System (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies in successfully obtaining CDSCO licenses, we understand the nuances involved in bringing innovative medical devices like the Gait Analysis System to the Indian market. This device, classified as a Class A medical device under the rehabilitation category, is intended to study walking or running patterns and is governed by specific regulatory provisions under the Central Drugs Standard Control Organization (CDSCO).
CDSCO Regulatory Framework for Gait Analysis System
The Gait Analysis System falls under Class A risk category as per the CDSCO’s risk classification. Such devices are considered low risk and are regulated primarily by the State Licensing Authority. The regulatory framework mandates a structured process involving documentation, testing, audit, and licensing before commercial distribution.
The device is notified under File No. 29/Misc./03/2020-DC (160) dated 04.08.2022, ensuring its compliance requirements are clearly defined.
Risk Classification and License Requirements
Medical devices in India are classified into four risk classes: A, B, C, and D, with Class A being the lowest risk category. The Gait Analysis System, being Class A, requires obtaining an MD5 Manufacturing License (application via Form MD3) before manufacturing and marketing.
- License Type: MD5 (Manufacturing License for Class A/B devices)
- Licensing Authority: State Licensing Authority
- Total Processing Time: Approximately 3-4 months (including test license, testing, audit)
- Fees: Rs 5,000 per application + Rs 500 per product
For detailed classification guidance, manufacturers can refer to the Medical Device Classification resource.
Manufacturing License Process (MD5) for Gait Analysis System
Test License (Form MD13):
- Obtain a test license first, which allows initial testing of the device.
- Processing time: 1.5 to 2 months.
Product Testing:
- Conduct product testing at CDSCO-approved government laboratories. Refer to the Testing Laboratories list.
Document Preparation:
- Compile all necessary documents including Device Master File, Plant Master File, Risk Management File, and others.
Application Submission (Form MD3):
- Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body:
- An audit is conducted by a notified body for compliance verification. Find notified bodies here.
Query Resolution:
- Address any queries raised by CDSCO or the notified body promptly.
Grant of License (Form MD5):
- Upon satisfactory review, the MD5 license is granted.
Manufacturing License Documents Required
To ensure a smooth application process for the Gait Analysis System, prepare the following documents:
- Company Constitution (e.g., MOA, AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire and Pollution NOCs
- Device Master File (DMF) detailing device specifications and design (Device Master File Guide)
- Plant Master File describing manufacturing site and processes (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance
- Risk Management File documenting hazard analyses and mitigations (Risk Management)
- Test Reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Gait Analysis System
While this guide focuses on manufacturing licenses, importers should note that the MD15 Import License is required for Class A devices imported into India. The MD15 license process involves document submission, application via Form MD14, query resolution, and license grant over approximately 5-6 months.
Key documents include Manufacturing License, Free Sale Certificate, CE Certificate, ISO 13485:2016, Device and Plant Master Files, and Wholesale License.
More detailed insights on import licensing are available in our Import License Guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 2 – 3 weeks |
| License Application (MD3) | Submission instant |
| Notified Body Audit | 2 – 4 weeks |
| Query Resolution | 2 – 4 weeks |
| License Grant | Total 3 – 4 months |
Government Fees and Costs
- Test License (MD13): Nominal fees as per state authority
- MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
- Product Testing: Varies depending on the number of tests and labs involved
- Audit Fees: Paid directly to notified bodies; varies based on scope and location
Budgeting for these costs upfront is crucial for timely project execution.
Common Challenges and Solutions
- Delayed Testing: Use CDSCO-approved labs with proven turnaround times (Testing Laboratories) to avoid bottlenecks.
- Incomplete Documentation: Prepare comprehensive Device and Plant Master Files to reduce queries.
- Audit Non-compliance: Conduct pre-audit internal checks and training.
- Query Delays: Assign dedicated personnel for prompt responses.
Our practical experience shows that early engagement with a notified body and thorough preparation significantly expedite the process.
Expert Consultation and Support
Navigating the regulatory landscape for devices like the Gait Analysis System requires deep expertise. Our consultancy offers end-to-end support—from document preparation, audit readiness, to application submission and follow-up with CDSCO.
We also assist in creating robust Device and Plant Master Files, crucial for audit and license approval, as outlined in our guides.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device class and applicable licensing requirements.
- Engage a CDSCO-Approved Testing Lab: Schedule product testing early.
- Prepare Documentation: Develop Device Master File, Plant Master File, Risk Management File, and QMS documents.
- Apply for Test License (MD13): Submit via the CDSCO MD Online Portal.
- Plan for Audit: Schedule audits with notified bodies listed here.
- Submit Manufacturing License Application (MD3): Post successful testing.
- Respond Promptly to Queries: Assign a dedicated team member.
By following these steps with expert guidance, manufacturers of the Gait Analysis System can efficiently navigate the CDSCO licensing pathway, ensuring timely market entry and compliance.
For personalized assistance, please contact our regulatory experts who specialize in Class A medical device licensing.
