CDSCO License for Electronic goniometer/kinesiol ogy sensor

Comprehensive Guide to CDSCO Licensing for Electronic Goniometer (Class B Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having successfully guided 500+ companies through the CDSCO licensing landscape, we understand the complexities involved in bringing medical devices like the Electronic Goniometer/kinesiology sensor to the Indian market. This device, categorized under rehabilitation and classified as a Class B medical device, requires precise compliance with CDSCO regulations to ensure timely approval and market access.

Understanding the Electronic Goniometer and Its Regulatory Importance

The Electronic Goniometer is an advanced rehabilitation device designed to measure the range of motion of individual joints, limbs, or spine. It is primarily used in clinical settings to evaluate patients before or after medical or surgical interventions and to assess physical fitness levels. Given its medical application in patient assessment, regulatory approval from the Central Drugs Standard Control Organization (CDSCO) is mandatory to ensure safety, efficacy, and quality standards.

CDSCO Regulatory Framework for Electronic Goniometer (Class B Device)

According to the CDSCO classification notified on 04.08.2022 (File No. 29/Misc./03/2020-DC (160)), this device falls under Class B (low-moderate risk). This classification dictates the licensing pathway, which involves the MD5 license obtained through the State Licensing Authority.

Risk Classification and License Requirements for Class B Devices

Class B devices like the Electronic Goniometer require manufacturers to obtain an MD5 Manufacturing License. This process involves obtaining a Test License (MD13), product testing by government-approved laboratories, and an audit by a notified body to ensure compliance with Indian Medical Device Rules.

Learn more about Medical Device Classification for deeper insights.

Manufacturing License Process for Electronic Goniometer (MD5 License)

The MD5 license process for Class B devices typically spans 3 to 4 months and includes the following sequential steps:

1. Test License Application (Form MD13): Apply for a test license to initiate product testing. This stage takes approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at government-approved labs to validate the device's safety and performance. Refer to the list of testing laboratories.
3. Document Preparation: Prepare comprehensive documentation including technical files, quality management systems, and risk assessments.
4. Application Submission (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo a thorough audit by a notified body. Review the Notified Bodies List to select an approved auditor.
6. Resolution of Queries: Address any questions or clarifications raised by CDSCO or the notified body.
7. Grant of MD5 License (Form MD5): Upon successful audit and document verification, the license is granted.

Manufacturing License Documents Required for Electronic Goniometer

To streamline your application, ensure you have the following documents ready:

• Company Constitution Documents (Incorporation, Partnership Deed, etc.)
• Proof of Ownership or Lease Agreement for manufacturing premises
• Technical Staff Details (Qualifications and experience)
• Fire and Pollution NOCs
• Device Master File (DMF) detailing device specifications and design (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facility and processes (Plant Master File Guide)
• Essential Principles Checklist verifying compliance with Indian Medical Device Rules
• Risk Management File addressing potential hazards (Risk Management)
• Test Reports from government-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation (ISO 13485:2016 compliance)

Import License Process for Electronic Goniometer (MD15 License)

If you are an importer, an MD15 Import License is required from the Central Licensing Authority. The typical timeline is 5 to 6 months. The process involves:

• Preparing and submitting application on Form MD14 via the CDSCO MD Online Portal
• Providing documents such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, and Wholesale License.
• Responding to departmental queries.
• Receiving the grant of MD15 license.

For detailed guidance, refer to our Import License Guide.

Import License Documents Required

• Valid Manufacturing License of the device from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution Documents

Timeline and Processing Duration

Government Fees and Costs

For the Electronic Goniometer under Class B:

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• MD15 Import License: $2,000 per site +$1,000 per product (approximate INR conversion applies)

Note: Additional costs include testing fees charged by labs and audit fees by notified bodies.

Common Challenges and Solutions

• Incomplete Documentation: Missing key files like Risk Management or Device Master File can cause delays. We recommend early preparation using our detailed guides.
• Testing Delays: Scheduling tests at government labs requires advance booking. Plan ahead and consider alternate approved labs if possible.
• Audit Non-conformities: Pre-audit internal checks and compliance training can minimize observations.
• Query Resolution Delays: Assign a dedicated regulatory expert to respond promptly to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing can be challenging, especially for Class B devices like the Electronic Goniometer, which require rigorous documentation and audits. Our team has supported over 500 companies in obtaining timely approvals by providing:

• Complete document preparation and review
• Coordination with notified bodies and testing labs
• Application submission and follow-up
• Training on compliance and audit readiness

Contact us for a tailored consultation to expedite your CDSCO licensing journey.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device falls under Class B as per CDSCO notification.
2. Prepare Documentation: Start compiling your Device Master File, Plant Master File, Risk Management File, QMS documents, and other mandatory paperwork.
3. Apply for Test License (MD13): Submit the test license application through the CDSCO MD Online Portal.
4. Plan Testing: Schedule product testing at an approved government lab.
5. Engage Notified Body: Select an auditor from the Notified Bodies List and schedule your audit.
6. Submit Manufacturing License Application (Form MD3): Once testing is complete, apply for the MD5 license.
7. Respond to Queries: Maintain open communication with CDSCO and the notified body to address any issues promptly.

By following these practical next steps and leveraging expert support, manufacturers and importers can efficiently navigate the CDSCO licensing process for the Electronic Goniometer and gain a competitive advantage in the Indian medical device market.