CDSCO License for Manual goniometer
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
Non powered device intended to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint.
Comprehensive Guide to CDSCO Licensing for Manual Goniometer (Class A Medical Device)
As a manual goniometer is a non-powered, low-risk medical device used in clinical settings to measure joint angles, it is classified as a Class A device under Indian regulations. Being an experienced regulatory consultant with over 25 years in the field and having supported more than 500 manufacturers and importers, we understand the nuances and practical steps involved in securing your CDSCO license efficiently.
Introduction: Manual Goniometer and Its Regulatory Importance
A manual goniometer is an essential rehabilitation device designed for accurate measurement of limb range of motion. Its non-powered nature and intended use in clinical settings classify it as a low-risk medical device (Class A) under CDSCO guidelines. Despite its low-risk status, compliance with CDSCO regulations is mandatory to ensure patient safety, product quality, and smooth market access in India. The CDSCO notification dated 04.08.2022 (File No. 29/Misc./03/2020-DC (160)) officially lists the manual goniometer in the rehabilitation category, making it subject to licensing requirements.
CDSCO Regulatory Framework for Manual Goniometer
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India through a risk-based classification system. Class A devices like the manual goniometer require a manufacturing license (MD5) issued by the State Licensing Authority. This framework ensures that low-risk devices are monitored without imposing overly burdensome requirements.
Risk Classification and License Requirements
- Device Risk Class: A (Low risk)
- Applicable License: MD5 Manufacturing License (Form MD3 for application, Form MD5 for license grant)
- Authority: State Licensing Authority
- License Process Duration: Approximately 3-4 months
Manufacturing License Process (MD5) for Manual Goniometer
The license process for Class A devices involves several critical steps:
Test License (MD13): Before applying for the MD5 license, manufacturers must obtain a Test License on Form MD13. This step allows product testing and typically takes 1.5 to 2 months.
Product Testing: Conduct testing at CDSCO-approved laboratories. For manual goniometers, tests usually cover accuracy, durability, and safety compliance. Refer to the list of testing laboratories authorized by CDSCO.
Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) details.
Application Submission: Submit the MD5 license application (Form MD3) with all required documents through the CDSCO MD Online Portal.
Notified Body Audit: A notified body will audit your manufacturing facility and documentation. Check the list of notified bodies to select an appropriate auditor.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant: Upon successful audit and query resolution, the State Licensing Authority issues the MD5 license (Form MD5).
Manufacturing License Documents Required
For the manual goniometer, you must submit the following documents:
- Company Constitution (Incorporation Certificate)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) — includes design, specifications, and manufacturing process (See our Device Master File guide)
- Plant Master File (PMF) — details of manufacturing facility (Plant Master File guide)
- Essential Principles Checklist
- Risk Management File (Risk Management insights)
- Product Test Reports from approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents (preferably ISO 13485:2016 certification)
Import License Process (MD15) for Manual Goniometer
If you plan to import manual goniometers into India, you'll require an Import License (MD15) issued by the Central Licensing Authority. The process includes:
- Document preparation: Manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, Device and Plant Master Files, Wholesale License, Company constitution.
- Application submission on the CDSCO MD Online Portal.
- Queries resolution and license grant (Form MD15).
Typical processing time is 5-6 months. Note that a Test License is not required for import.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Device Master File and Plant Master File
- Wholesale license for distribution in India
- Company Constitution
Timeline and Processing Duration
| Process Step | Duration (Approx.) |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 month |
| Document Preparation | 2 - 3 weeks |
| Application Review & Audit | 1 - 1.5 months |
| Query Resolution | 2 - 3 weeks |
| Total MD5 License Time | 3 - 4 months |
Import license processing takes 5-6 months due to central authority involvement.
Government Fees and Costs
- MD5 Manufacturing License: Rs. 5000 per application + Rs. 500 per product (manual goniometer considered one product)
- Test License (MD13): Included in above process costs
- Notified Body Audit Fees: Varies by notified body; typically Rs. 50,000 to Rs. 1,00,000 depending on scope
- Product Testing Fees: Approx. Rs. 20,000 to Rs. 50,000 depending on tests required
Budgeting realistically for approximately Rs. 80,000 to Rs. 1,50,000 ensures smooth processing without last-minute surprises.
Common Challenges and Practical Solutions
- Delay in product testing: Plan testing early and select government-approved labs with proven turnaround times.
- Incomplete documentation: Use detailed checklists and professional templates, especially for Device and Plant Master Files.
- Audit non-compliance: Pre-audit your facility with a notified body consultant to identify and rectify gaps.
- Query resolution delays: Assign a dedicated team member to monitor and respond promptly to licensing authority queries.
Expert Consultation and Support
With over 25 years of experience and 500+ successful CDSCO license applications, we provide end-to-end assistance from dossier preparation to audit readiness. Our expertise includes:
- Tailoring Device and Plant Master Files specific to manual goniometers
- Liaising with notified bodies and testing labs
- Managing timelines to meet market launch deadlines
- Providing risk management and QMS implementation consultancy
Getting Started with Your CDSCO License Application
Assess your device classification: Confirm manual goniometer as Class A using the Medical Device Classification tool.
Register on CDSCO MD Online Portal: Create your account and familiarize yourself with submission requirements.
Gather required documents: Begin collecting company and technical documents. Use our Device Master File guide and Plant Master File guide as templates.
Apply for Test License (MD13): Submit early to avoid delays.
Schedule product testing: Book slots with government-approved labs.
Prepare for notified body audit: Choose a notified body from the official list and conduct a pre-audit if possible.
Submit MD5 application: Once testing and documentation are complete, file your application through the CDSCO portal.
By following these actionable steps and leveraging our expertise, manufacturers and importers can ensure a smooth and timely market entry for manual goniometers in India.
