CDSCO License for Stand-on patient scale
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 for medical purposes that is used to weigh a patient who is able to stand on the scale platform.
Comprehensive Guide to CDSCO Licensing for Stand-on Patient Scale (Class A Medical Device)
Manufacturers and importers of stand-on patient scales, classified as Class A medical devices under the CDSCO regulatory framework, must navigate a detailed process to legally market their devices in India. As a company with over 25 years of expertise in regulatory affairs, having supported 500+ clients, we provide you with a practical, step-by-step overview to secure your CDSCO license efficiently.
Understanding the Stand-on Patient Scale and Its Regulatory Importance
A stand-on patient scale is a medical device used to measure the weight of patients who can stand on the platform. It falls under the category of General Hospital or Orthopaedic Instruments and is classified as Class A according to the CDSCO notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. Despite being low-risk, regulatory compliance is crucial to ensure patient safety and market access.
CDSCO Regulatory Framework for Stand-on Patient Scale
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Class A devices like the stand-on patient scale require licensing from the State Licensing Authority via the MD5 route. This involves adherence to Indian Medical Device Rules 2017 for manufacturing, quality management, and documentation.
Risk Classification and License Requirements
- Device: Stand-on Patient Scale
- Risk Class: A (Low Risk)
- Applicable License: MD5 Manufacturing License (Form MD3)
- Regulatory Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months
For detailed classification, manufacturers can refer to the Medical Device Classification guide.
Manufacturing License Process (MD5) for Stand-on Patient Scale
Obtaining an MD5 license entails several sequential steps:
- Test License Application (Form MD13): Apply for a test license to conduct product testing; processing takes about 1.5-2 months.
- Product Testing: Get your stand-on patient scale tested at government-approved laboratories. Refer to the list of Testing Laboratories for authorized facilities.
- Document Preparation: Compile required technical, quality, and compliance documents.
- MD5 License Application (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
- Notified Body Audit: Engage a notified body for a mandatory factory audit. You can find the list of notified bodies here.
- Query Resolution: Address any queries raised by the regulatory authority or notified body.
- Grant of MD5 License: On successful completion, the license is issued on Form MD5.
Manufacturing License Documents Required for Stand-on Patient Scale
Prepare the following documents meticulously to avoid delays:
- Company Constitution (MOA/AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Details of Technical Staff (CVs, Qualifications)
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Includes design, specifications, and manufacturing details. Our Device Master File guide can help you prepare this.
- Plant Master File (PMF): Details of manufacturing facilities; refer to our Plant Master File Guide.
- Essential Principles Checklist
- Risk Management File
- Test Reports from approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 compliance recommended)
Import License Process (MD15) for Stand-on Patient Scale
If you are an importer, the import license (MD15) is granted by the Central Licensing Authority. The process typically takes 5-6 months and includes:
- Document preparation (manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files)
- Application submission on the CDSCO MD Online Portal
- Query resolution
- License grant on Form MD15
For importers, detailed guidance is available in our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks |
| Document Preparation | 2 to 4 weeks |
| MD5 License Application | 1 month |
| Notified Body Audit | 3 to 4 weeks |
| Query Resolution | 2 to 3 weeks |
| Total Duration | Approximately 3-4 months |
Government Fees and Costs
- MD5 License Application Fee: Rs. 5,000 per application
- Per Product Fee: Rs. 500 per product
- Additional costs include product testing fees, notified body audit charges (variable), and preparation of technical documentation.
Common Challenges and Solutions
- Delayed Testing and Audit Scheduling: Plan early and book slots at notified bodies and testing labs well in advance.
- Incomplete Documentation: Use checklists and expert reviews to ensure all documents meet CDSCO requirements.
- Query Resolution Delays: Maintain open communication with regulatory authorities and respond promptly to queries.
- QMS Implementation: ISO 13485:2016 certification streamlines approval; consider engaging consultants if unfamiliar.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our extensive experience helping over 500 companies means we understand the nuances of regulatory compliance for devices like stand-on patient scales. We offer tailored support from documentation to audit preparation to ensure efficient license grant.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device is Class A under the latest CDSCO notifications.
- Prepare Technical Documentation: Leverage our Device Master File and Plant Master File guides.
- Apply for Test License (MD13): Submit your application through the CDSCO MD Online Portal.
- Schedule Product Testing: Coordinate with government-approved labs early.
- Engage a Notified Body: Choose from the notified bodies list for your audit.
- Submit MD5 License Application: Complete and submit Form MD3 after test reports and audit.
- Prepare for Audit and Query Response: Stay proactive in communications.
By following these actionable steps and leveraging expert guidance, manufacturers and importers can successfully obtain their CDSCO licenses for the stand-on patient scale and confidently enter the Indian medical device market.
