CDSCO License for Cervicothoracic spine orthosis
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 to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine.
Comprehensive Guide to CDSCO Licensing for Cervicothoracic Spine Orthosis (Class A Medical Device)
As a medical device manufacturer or importer aiming to enter the Indian market with the Cervicothoracic spine orthosis, understanding the regulatory landscape is essential. This device, categorized under physical supports and classified as Class A (low risk) by CDSCO, requires a meticulous licensing process to ensure compliance and market access. With over 25 years of experience and having assisted more than 500 companies, we provide you with a detailed, practical roadmap to secure your CDSCO license effectively.
Understanding the Device and Its Regulatory Importance
The Cervicothoracic spine orthosis is designed to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine. Given its critical role in patient safety and treatment outcomes, regulatory oversight ensures that such devices meet quality, safety, and efficacy standards before entering the Indian market.
The device is notified under File No. 29/Misc./03/2020-DC (202) dated 26.7.2021, confirming its classification as a Class A device under the physical support category.
CDSCO Regulatory Framework for Cervicothoracic Spine Orthosis
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulations in India. For Class A devices like the cervicothoracic spine orthosis, the State Licensing Authority issues manufacturing licenses under the MD5 license regime.
The licensing process encompasses:
- Obtaining a Test License (Form MD13)
- Product testing in approved laboratories
- Documentation and application submission (Form MD3)
- Audit by a notified body
- Resolution of queries
- Final license grant (Form MD5)
Risk Classification and License Requirements
Our device falls under Class A, which is considered low risk. This classification mandates an MD5 manufacturing license granted by the State Licensing Authority.
Key points:
- Test license required (MD13)
- Product testing mandatory
- Audit by notified bodies
- Total timeline: approximately 3-4 months
- Government fees: Rs 5,000 per application + Rs 500 per product
For a detailed understanding of device classification, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5)
The MD5 license process is designed to ensure your cervicothoracic spine orthosis complies with Indian regulatory standards.
Apply for a Test License (Form MD13):
- Submit application via the CDSCO MD Online Portal.
- Processing time: 1.5 to 2 months.
Product Testing:
- Conduct testing at CDSCO-approved laboratories.
- Refer to the Testing Laboratories list for authorized centers.
Documentation Preparation:
- Compile technical documents required for license application.
Submit Manufacturing License Application (Form MD3):
- Upload all documents and test reports via the CDSCO portal.
Audit by Notified Body:
- Arrange audit per guidelines.
- Find an authorized auditor from the Notified Bodies List.
Query Resolution:
- Address any observations raised by department or auditors promptly.
Grant of License (Form MD5):
- Upon successful audit and document verification, license is issued.
Manufacturing License Documents Required for Cervicothoracic Spine Orthosis
To streamline your application, prepare the following documents carefully:
- Company Constitution: Registration certificates of your business entity.
- Proof of Ownership or Lease of Premises: Legal documents confirming manufacturing site.
- Technical Staff Details: Qualification and experience certificates of personnel.
- Fire NOC: Fire safety clearance certificate.
- Pollution NOC: Environmental clearance certificate.
- Device Master File (DMF): Detailed device design, manufacturing process, and quality info. Our Device Master File Guide can assist you.
- Plant Master File (PMF): Manufacturing site specifics. Refer to our Plant Master File Guide for best practices.
- Essential Principles Checklist: Compliance checklist as per Indian regulations.
- Risk Management File: Documentation of risk assessments and mitigation strategies. Learn more about Risk Management implementation.
- Test Reports: From CDSCO-approved labs.
- Labels and Instructions for Use (IFU): Device labeling and user manual.
- Quality Management System (QMS) Documents: ISO 13485 certification and related SOPs.
Import License Process (MD15) for Cervicothoracic Spine Orthosis
If you intend to import this device, you must secure an MD15 import license from the Central Licensing Authority.
Key steps:
- Prepare documents including your manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), DMF, PMF, wholesale license, and company constitution.
- Apply using Form MD14 on the CDSCO MD Online Portal.
- Processing time: Approximately 5-6 months.
- Fees vary by class; for Class A, expect around 50 per product.
For detailed guidance, review our Import License Guide.
Import License Documents Required
Prepare the following for MD15 application:
- Valid Manufacturing License (MD5 or MD9)
- Free Sale Certificate from country of origin
- ISO 13485:2016 Certification
- CE Certificate or equivalent (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution and other corporate documents
Timeline and Processing Duration
| License Type | Stage | Duration (Approx.) |
|---|---|---|
| Test License (MD13) | Application to grant | 1.5 – 2 months |
| Product Testing | Sample analysis | 2 – 3 weeks |
| MD5 License | Application to grant | 1.5 – 2 months |
| Total (MD5) | Entire process | 3 – 4 months |
This timeline assumes prompt document submission and no major audit or query delays.
Government Fees and Costs
| Fee Type | Amount (INR) |
|---|---|
| MD5 Application Fee | Rs 5,000 |
| Per Product Fee | Rs 500 |
Additional costs include:
- Product testing fees at approved labs
- Audit fees charged by notified bodies
- Consultant fees (if applicable)
Common Challenges and Practical Solutions
Challenge 1: Delays in Test License Approval
- Solution: Pre-submit complete and accurate documentation, track application status regularly on the CDSCO MD Online Portal.
Challenge 2: Product Testing Failures or Delays
- Solution: Choose an authorized, well-equipped testing laboratory from the Testing Laboratories list with experience in physical support devices.
Challenge 3: Audit Non-Compliance
- Solution: Conduct pre-audit internal checks using a checklist aligned with notified body requirements. Engage experts for gap analysis.
Challenge 4: Document Gaps or Incomplete Submissions
- Solution: Use our comprehensive Device and Plant Master File guides and risk management templates to ensure completeness.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for first-time applicants. Our seasoned consultants have guided 500+ companies through:
- Regulatory strategy
- Document preparation
- Liaison with CDSCO and notified bodies
- Audit readiness
- Query handling
Leveraging our expertise reduces approval times and enhances compliance confidence.
Getting Started with Your CDSCO License Application
To initiate your application for the cervicothoracic spine orthosis MD5 manufacturing license, follow these practical next steps:
Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the submission interface.
Prepare your Facility and Documentation: Complete your Device Master File, Plant Master File, and risk management documentation.
Apply for the Test License (MD13): Submit your test license application with complete documents.
Plan for Product Testing: Coordinate with an approved testing laboratory early to avoid delays.
Schedule Audit: After successful testing, arrange for audit by a notified body.
Submit MD5 License Application (Form MD3): Upload all required documents and test reports.
Monitor Application Progress: Respond promptly to any queries or additional information requests.
Engaging with experienced consultants at this stage can help streamline the process and avoid common pitfalls.
By following this detailed guide and leveraging expert support, manufacturers and importers of the cervicothoracic spine orthosis can confidently navigate the CDSCO regulatory pathway, ensuring timely market entry and compliance with Indian medical device regulations.
