CDSCO License for 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
A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scaleby placing scale under a bed or chair to weigh both the support and the patient.

Introduction to Patient Scales and Their Regulatory Importance in India
Patient scales are essential medical devices used in hospitals and clinics to accurately measure the weight of patients who are unable to stand, by placing the scale under a bed or chair. Classified under General Hospital or Orthopaedic Instruments, patient scales play a vital role in patient care management. Given their medical purpose and direct impact on treatment decisions, regulatory compliance by the Central Drugs Standard Control Organization (CDSCO) is mandatory before commercializing these devices in India.
With over 25 years of experience and having assisted 500+ companies in navigating the CDSCO licensing landscape, we understand the nuances involved in securing approvals for Class A medical devices like patient scales. This comprehensive guide walks you through the CDSCO regulatory framework, licensing processes, document requirements, timelines, costs, and practical insights to ensure your patient scale reaches the Indian market smoothly.
CDSCO Regulatory Framework for Patient Scales
Patient scales are categorized as Class A medical devices, considered low risk by CDSCO. They fall under the notification 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022. This notification mandates manufacturers and importers to obtain appropriate licenses under CDSCO’s regulatory framework before manufacturing or importing these devices.
The primary regulatory pathway for manufacturing patient scales involves obtaining an MD5 license, issued by the State Licensing Authority. Importers, meanwhile, must secure an MD15 import license from the Central Licensing Authority. Compliance with Indian quality standards and adherence to the Essential Principles of Safety and Performance are prerequisites.
Risk Classification and License Requirements for Patient Scales
- Risk Class: A (Low Risk)
- Applicable License: MD5 Manufacturing License (Form MD3)
- Licensing Authority: State Licensing Authority
- Import License: MD15 License (Form MD14) from Central Licensing Authority
The Class A designation simplifies the approval process but does not eliminate the need for comprehensive documentation, testing, and audits.
Manufacturing License Process for Patient Scales (MD5 License)
The manufacturing license process for patient scales involves several critical steps:
Obtain Test License (Form MD13): Before applying for MD5, manufacturers must acquire a test license which takes approximately 1.5 to 2 months. This license allows product testing in government-approved laboratories.
Product Testing: Conduct mandatory product testing in labs approved by CDSCO to validate compliance with Indian standards. Refer to the Testing Laboratories list for authorized facilities.
Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Quality Management System (QMS) documents, and more.
Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal along with the required fees.
Audit by Notified Body: An audit is carried out by a notified body to verify compliance with manufacturing practices and documentation. Check the Notified Bodies list to select an approved auditor.
Resolution of Queries: Address any queries or deficiencies raised by the CDSCO or the notified body promptly.
Grant of License (Form MD5): Upon successful audit and document verification, the license is granted.
For detailed guidance on the MD5 license process, refer to our MD5 License Guide.
Manufacturing License Documents Required for Patient Scale
- Company Constitution (Registration Certificate)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- No Objection Certificates (NOCs) for Fire Safety and Pollution Control
- Device Master File (DMF) – detailed device specifications and manufacturing process (Device Master File Guide)
- Plant Master File – manufacturing facility details (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance requirements
- Risk Management File addressing potential device risks (Risk Management)
- Test Reports from government-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation (e.g., ISO 13485)
Ensuring accuracy and completeness of these documents minimizes delays during the licensing process.
Import License Process for Patient Scales (MD15 License)
For importers of patient scales, the MD15 import license must be obtained from CDSCO’s Central Licensing Authority. The key steps include:
Document Preparation: Compile all necessary documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.
Application Submission (Form MD14): Submit your import license application through the CDSCO MD Online Portal.
Queries Resolution: Respond promptly to any questions or document requests from CDSCO.
License Grant: Upon satisfactory review, CDSCO issues the MD15 import license.
The import license process typically spans 5 to 6 months.
For deeper insights, view our Import License Guide.
Import License Documents Required
- Valid Manufacturing License of the Device in the Country of Manufacture
- Free Sale Certificate issued by the competent authority
- ISO 13485:2016 Certification
- CE Certificate or equivalent quality certifications
- Device Master File and Plant Master File
- Wholesale License for Importer
- Company Constitution/Registration Certificate
- Product Labels and Instructions for Use
Accurate documentation reflecting the device’s compliance with international and Indian standards is critical.
Timeline and Processing Duration
Process Step | Duration |
---|---|
Test License (MD13) | 1.5 – 2 months |
Product Testing | 1 – 1.5 months |
Document Preparation | 2 – 3 weeks |
License Application & Audit | 1.5 – 2 months |
Query Resolution | 2 – 4 weeks |
Total MD5 License Process | 3 – 4 months |
Import license (MD15) generally takes 5 to 6 months, given no test license is needed.
Government Fees and Costs
MD5 License:
- Application Fee: Rs. 5000
- Fee per Product: Rs. 500
MD15 Import License:
- Class A Devices: 50 per product
Additional costs include testing fees charged by laboratories, audit fees payable to notified bodies, and consultancy fees if availing expert support.
Common Challenges and Solutions
Incomplete Documentation: Missing or incorrect documents commonly delay approvals. We recommend using detailed checklists and conducting internal audits before submission.
Delayed Testing and Audit Scheduling: Early booking of testing services and notifying the notified body can prevent bottlenecks.
Non-Compliance with Essential Principles: Thorough risk management and adherence to quality standards mitigate regulatory queries.
Lack of Familiarity with Regulatory Changes: Staying updated with CDSCO notifications and guidance documents is essential.
Our seasoned consultants have successfully navigated these challenges, enabling clients to achieve timely approvals.
Expert Consultation and Support
With 25+ years in the medical device regulatory domain and over 500 successful CDSCO license grants, our team offers:
- Comprehensive regulatory strategy planning
- Document preparation and review
- Coordination with notified bodies and CDSCO officials
- End-to-end application management
Reach out to us early in your product development cycle to streamline compliance and reduce time-to-market.
Getting Started with Your CDSCO License Application for Patient Scales
Assess Your Device Classification: Confirm your patient scale’s Class A status via the Medical Device Classification guide.
Prepare Your Documentation: Begin compiling all necessary files using our Device and Plant Master File guides.
Apply for Test License (MD13): Submit your test license application on the CDSCO MD Online Portal.
Schedule Product Testing: Book slots at CDSCO-approved testing laboratories.
Engage a Notified Body: Select an appropriate notified body from the Notified Bodies list to plan your audit.
Submit MD5 Application: Once testing and documentation are ready, apply for the manufacturing license.
Prepare for Audit and Queries: Respond promptly to ensure smooth license grant.
Starting early with these actionable steps and leveraging expert support can significantly accelerate your CDSCO licensing journey for patient scales.
For personalized assistance, contact our regulatory consultants who are dedicated to simplifying the Indian medical device licensing process for you.