CDSCO License for Back Support/Brace
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 back brace prevents unnecessary movements that further damage the back. This helps align your spine and strengthen your back muscles. Patients back can heal and back pain will decrease.
Introduction to Back Support/Brace and Regulatory Importance
Back Support Braces are vital rehabilitation medical devices designed to prevent unnecessary spinal movements, supporting proper alignment and muscle strengthening to facilitate healing and reduce back pain. Given their therapeutic significance, regulatory compliance is crucial for ensuring safety, efficacy, and market access in India.
As specialists with over 25 years of experience and having guided 500+ companies through CDSCO licensing, we understand the nuances involved in obtaining approvals for Class A devices like Back Braces. This comprehensive guide demystifies the entire process, empowering manufacturers and importers to confidently navigate the regulatory landscape.
CDSCO Regulatory Framework for Back Support/Brace (Class A Devices)
Under the Medical Device Rules (2017), Back Support/Braces are categorized as Class A devices due to their low risk profile. These devices fall under the Rehabilitation category and must comply with the CDSCO notification [File No. 29/Misc./03/2020-DC (160)] dated 04.08.2022.
Compliance ensures that the device meets quality, safety, and performance standards mandated by Indian regulations, protecting end users and facilitating market acceptance.
Risk Classification and License Requirements
According to CDSCO’s risk classification, Back Support/Braces are Class A medical devices (low risk). As such, manufacturers must obtain an MD5 Manufacturing License, which is issued by the respective State Licensing Authority.
The MD5 license process involves:
- Obtaining a Test License (Form MD13)
- Product testing at government-approved laboratories
- Document preparation and submission
- Notified Body audit
- Resolution of departmental queries
For more on device classification, refer to our detailed Medical Device Classification guide.
Manufacturing License Process (MD5) for Back Support/Brace
- Test License Application (Form MD13): Before manufacturing, apply for a Test License, which typically takes 1.5–2 months for approval.
- Product Testing: Conduct testing of the Back Brace at CDSCO-approved labs. Testing ensures compliance with essential principles and safety standards.
- Document Preparation: Compile all required documentation, including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
- Application for MD5 License (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: Engage a notified body from the official list for a facility audit.
- Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
- Grant of License (Form MD5): Upon successful audit and document acceptance, the State Licensing Authority issues the MD5 license.
Manufacturing License Documents Required
For your Back Support/Brace manufacturing license application, prepare the following:
- Company Constitution (e.g., MOA, AOA)
- Proof of Ownership or Tenancy Agreement of manufacturing premises
- Qualification and experience documents of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, manufacturing process, and controls (DMF Guide)
- Plant Master File (PMF) covering facility details (PMF Guide)
- Essential Principles Compliance Checklist
- Risk Management File specific to Back Support/Brace (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories (Testing Laboratories List)
- Product Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) documentation aligned with ISO 13485
Import License Process (MD15) for Back Support/Brace
If you plan to import Back Support/Braces into India, the process involves:
- Document preparation including manufacturing license, Free Sale Certificate, ISO 13485 certification, CE certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
- Application submission via the CDSCO MD Online Portal.
- Addressing queries raised by CDSCO.
- License issuance (MD15) by the Central Licensing Authority.
Note: Test license is not required for import applications.
For a detailed walkthrough, consult 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
Timeline and Processing Duration
| License Type | Timeline | Key Steps |
|---|---|---|
| Test License (MD13) | 1.5–2 months | Application, lab testing |
| Manufacturing License (MD5) | 3–4 months total | Document prep, audit, query resolution |
| Import License (MD15) | 5–6 months | Document prep, query resolution |
Manufacturers should plan for approximately 4 months from test license application to final manufacturing license receipt for Class A devices.
Government Fees and Costs
For Back Support/Brace (Class A), the fees are:
- MD5 License Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
Additional costs include:
- Testing laboratory charges (varies by test complexity)
- Notified body audit fees (varies by body and scope)
- Consultant fees if applicable
Budgeting accurately for these fees helps prevent delays.
Common Challenges and Solutions
Challenge: Delays in test license approval or product testing.
Solution: Submit complete and accurate test license applications early; choose CDSCO-recognized testing labs with proven turnaround times.
Challenge: Non-compliance during notified body audit.
Solution: Conduct internal mock audits; maintain thorough documentation; implement corrective actions swiftly.
Challenge: Incomplete or inconsistent documentation causing queries.
Solution: Cross-verify all documents against CDSCO checklists; leverage expert document review services.
Challenge: Labeling or IFU discrepancies.
Solution: Follow CDSCO labeling guidelines strictly; use templates that comply with regulatory requirements.
Expert Consultation and Support
Navigating CDSCO licensing for Back Support/Braces can be complex. Leveraging our 25+ years of expertise, we have streamlined processes to minimize delays and maximize approval success. Our services include:
- End-to-end license application management
- Gap analysis for documentation
- Pre-audit readiness checks
- Regulatory strategy consultation
Contact us to discuss your specific needs and receive personalized guidance.
Getting Started with Your CDSCO License Application
- Assess your device classification: Confirm Back Support/Brace as Class A and understand regulatory requirements.
- Prepare documentation: Begin compiling the Device Master File, Plant Master File, and risk management files.
- Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
- Schedule product testing: Coordinate with CDSCO-recognized labs early to avoid bottlenecks.
- Plan for audit: Select a notified body from the official list and prepare your facility.
- Submit manufacturing license application (MD5): After testing and documentation readiness, apply via the portal.
- Respond promptly: Address any queries from CDSCO or auditors without delay.
By following these steps, manufacturers and importers can confidently navigate the regulatory process, ensuring timely market entry and compliance for Back Support/Braces in India.
