CDSCO License for Infant scale, electronic
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
An electrically-powered device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes, e.g., during critical care procedures. It typically consist of a weight tray, a flexure plate or bending beam, an electronic transducer, and an analogue or digital display; it may include markings to also measure infant length. The device is also known as paediatric or baby scale.
Comprehensive Guide to CDSCO Licensing for Infant Electronic Scales (Class A Medical Devices)
As seasoned regulatory consultants with over 25 years of experience and having successfully supported more than 500 companies in obtaining CDSCO licenses, we understand the nuances of bringing pediatric and neonatology devices like the Infant Electronic Scale into the Indian market. This electrically-powered device designed to measure infant weight plays a vital role in critical care and routine monitoring. Given its classification as a Class A medical device under CDSCO, obtaining the right license is crucial for legal compliance and market access.
CDSCO Regulatory Framework for Infant Electronic Scales
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Infant electronic scales, classified as Class A devices under the Medical Device Rules, require a manufacturing license from the State Licensing Authority or an import license from the Central Licensing Authority. The key regulatory notification for this device is File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021, which officially classifies and regulates these devices.
Risk Classification and License Requirements
The Infant Electronic Scale falls under Class A, the lowest risk category, which simplifies the licensing pathway compared to higher-risk devices. However, compliance is mandatory and involves obtaining an MD5 manufacturing license (Form MD3) or an MD15 import license (Form MD14).
| License Type | Authority | Timeline | Fees (INR) | Key Steps |
|---|---|---|---|---|
| MD5 Manufacturing | State Licensing Authority | 3-4 months | ₹5,000 + ₹500 per product | Test license, product testing, audit |
| MD15 Import | Central Licensing Authority | 5-6 months | Variable; ₹75,000 approx total | Document submission, query resolution |
Manufacturing License Process (MD5) for Infant Electronic Scales
For manufacturers, the MD5 license process begins with obtaining a test license (Form MD13), valid for 6 months, enabling product testing in government-approved laboratories. This step generally takes 1.5 to 2 months.
Next, the device must undergo mandatory testing, including accuracy, electrical safety, and biocompatibility, at CDSCO-recognized laboratories. You can find an updated list of Testing Laboratories here.
Following successful testing, prepare the comprehensive license application using Form MD3 and submit it via the CDSCO MD Online Portal. The application includes detailed documentation and initiates an audit by a notified body. Refer to the list of notified bodies for audit services.
Once the audit report and documentation are satisfactory, CDSCO resolves any queries and grants the MD5 license (Form MD5).
Manufacturing License Documents Required
Successful MD5 application demands meticulous documentation, including:
- Company Constitution and Legal Entity Proof
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Personnel
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
- Plant Master File covering manufacturing site capabilities (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File showcasing hazard identification and mitigation strategies (Risk Management)
- Test Reports from approved labs confirming device compliance
- Labeling and Instructions for Use (IFU) documentation
- Quality Management System (QMS) documents, preferably ISO 13485 certified
Import License Process (MD15) for Infant Electronic Scales
Importers must apply for an MD15 license, which is centrally granted and takes approximately 5-6 months. Unlike manufacturing, import licensing does not require a test license but demands comprehensive documentation upfront.
The application form is MD14, submitted through the CDSCO MD Online Portal. The process involves document scrutiny, query resolution, and final license issuance.
Import License Documents Required
Key documents include:
- Manufacturing License issued by the country of origin
- Free Sale Certificate or Certificate of Market Authorization
- ISO 13485:2016 Certification
- CE Certificate or equivalent quality approval
- Device Master File and Plant Master File
- Wholesale Drug License for distribution in India
- Company Constitution and Legal Entity Proof
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| Application Submission and Review | 1 month |
| Audit and Query Resolution | 2 - 4 weeks |
| Final License Grant | Within total 3-4 months (MD5) |
For imports (MD15), the timeline typically extends to 5-6 months due to centralized evaluation.
Government Fees and Costs
- MD5 Manufacturing License: ₹5,000 per application + ₹500 per product
- MD15 Import License: Fees vary by device class; for Class A devices, approximately 50 per product (converted to INR as per exchange rates)
Budgeting for testing, notified body audits, and document preparation support is essential to avoid delays.
Common Challenges and Solutions
Challenge: Delays in product testing due to backlog at government labs.
Solution: Plan early and consider accredited private labs approved by CDSCO to expedite testing.
Challenge: Non-compliance in documentation leading to repeated queries.
Solution: Engage experienced regulatory consultants to prepare and review documents before submission.
Challenge: Scheduling audits with notified bodies.
Solution: Refer to the latest Notified Bodies List and book audits well in advance.
Expert Consultation and Support
Navigating Indian medical device regulations can be complex, especially for specialized devices like infant electronic scales. Our team offers end-to-end support—from preparing your Device Master File to guiding you through audits and application submissions.
We tailor strategies based on your unique manufacturing or import setup, ensuring compliance and timely license approvals.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm your device falls under Class A and understand the specific regulatory requirements.
- Prepare Comprehensive Documentation: Utilize our expert guides on Device Master Files and Plant Master Files.
- Initiate Testing Procedures: Apply for the test license (MD13) early and schedule product testing at approved labs.
- Submit Application via CDSCO MD Online Portal: Ensure all documents are complete and accurate before submission at the CDSCO MD Online Portal.
- Coordinate Audit and Query Resolution: Work closely with notified bodies and CDSCO inspectors to address any concerns swiftly.
Starting your licensing journey with expert guidance minimizes risks, accelerates approval, and ensures your infant electronic scale reaches the Indian healthcare market promptly and compliantly.
For personalized assistance, contact our regulatory team today and leverage our 25+ years of expertise to secure your CDSCO license with confidence.
