CDSCO License for TruncalOrthosis

Introduction to TruncalOrthosis and Regulatory Importance

TruncalOrthosis devices play a vital role in rehabilitation by supporting or immobilizing fractures, strains, or sprains of the neck and trunk. These include abdominal, cervical, lumbar, thoracic orthoses, and clavicle splints, essential for patient recovery. Given their medical purpose, these devices must comply with India's regulatory framework governed by the Central Drugs Standard Control Organization (CDSCO). Securing the appropriate CDSCO license is crucial for legal manufacturing and marketing within India, ensuring safety and quality standards are met.

With over 25 years of expertise and having guided 500+ companies through CDSCO approvals, we provide practical insights tailored specifically for Class A devices like the TruncalOrthosis.

CDSCO Regulatory Framework for TruncalOrthosis

TruncalOrthosis devices fall under the Rehabilitation category and are classified as Class A devices according to the CDSCO medical device classification system. This classification mandates obtaining a manufacturing license known as the MD5 license, issued by the State Licensing Authority.

This device is covered under Notification File No. 29/Misc./03/2020-DC (160), dated 04.8.2022, which outlines the regulatory context for such orthoses.

Risk Classification and License Requirements for Class A Devices

Class A devices represent the lowest risk category and include non-invasive orthoses like TruncalOrthosis. For these, the CDSCO requires manufacturers to obtain an MD5 license (application form MD3) from the State Authority. The process involves initial test license acquisition, product testing, audit by a notified body, and final license grant.

Importers of such devices require an MD15 import license from the Central Licensing Authority.

Detailed classification guidance can be found in the Medical Device Classification resource.

Manufacturing License Process (MD5) for TruncalOrthosis

1. Apply for a Test License (Form MD13): Before manufacturing, the company must obtain a test license to produce samples for testing. This typically takes 1.5 to 2 months.

2. Product Testing: Conduct tests at CDSCO-approved laboratories. Testing ensures compliance with safety and performance standards. You can find a list of Testing Laboratories here.

3. Documentation Preparation: Prepare essential documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Submit Manufacturing License Application (Form MD3): Apply via the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body performs a factory audit to assess compliance. Refer to the Notified Bodies List to select the appropriate agency.

6. Resolve Queries: Address any observations raised during audit or by CDSCO.

7. License Grant: Upon satisfactory compliance, the MD5 license is granted.

For a detailed overview, see our MD5 License Guide.

Manufacturing License Documents Required for TruncalOrthosis

• Company Constitution and Incorporation certificates
• Proof of ownership or lease of manufacturing premises
• Qualification and experience documents of technical staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process. Learn more in our Device Master File Guide
• Plant Master File describing the manufacturing facility and quality controls. See our Plant Master File Guide
• Essential Principles Checklist ensuring compliance with regulatory requirements
• Risk Management File documenting hazard analysis and mitigation strategies. More on Risk Management
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process (MD15) for TruncalOrthosis

For companies importing TruncalOrthosis devices, an MD15 import license is mandatory. The process includes:

1. Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.

2. Application Submission: Apply online through the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Address any queries raised by the CDSCO department.

4. License Issuance: The license is granted on Form MD15.

For further guidance, consult our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution documents

Timeline and Processing Duration

• Test License (MD13): Approximately 1.5 to 2 months
• Product Testing: 3 to 4 weeks depending on lab workload
• MD5 License Processing: 1.5 to 2 months including audit and query resolution

Total time from start to finish: Approximately 3 to 4 months for Class A TruncalOrthosis manufacturing license.

Import licenses (MD15) typically take 5 to 6 months.

Government Fees and Costs

• MD5 License: Application fee Rs. 5,000 + Rs. 500 per product
• Test License (MD13): Included in the process, no separate fee specified
• Audit Fees: Paid directly to notified bodies, varies by agency

Import license fees vary by device class and site; for Class A devices, fees are approximately $1000 per site and$50 per product.

Common Challenges and Solutions

Challenge: Delays in product testing due to lab capacity constraints.

• Solution: Plan testing early and coordinate with CDSCO-approved labs listed here.

Challenge: Incomplete or inconsistent documentation leading to audit observations.

• Solution: Utilize comprehensive templates for Plant and Device Master Files and ensure the QMS aligns with ISO 13485 standards.

Challenge: Misunderstanding the scope of audit by notified bodies.

• Solution: Engage with notified bodies beforehand and prepare for audit based on the notified body's checklist, accessible via the Notified Bodies List.

Expert Consultation and Support

Navigating the CDSCO licensing pathway for TruncalOrthosis can be complex. We have supported over 500 manufacturers and importers in successfully obtaining licenses by offering:

• Document preparation and gap analysis
• Coordination with notified bodies and testing labs
• Regulatory strategy customized for your product

Partnering with experienced consultants ensures timely approvals and compliance.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm TruncalOrthosis as Class A.

2. Prepare initial documentation: Gather company, technical, and facility documents.

3. Apply for the Test License (MD13): Submit through the CDSCO MD Online Portal.

4. Coordinate product testing: Schedule testing at a CDSCO-approved lab.

5. Compile complete documentation: Use our guides for Device and Plant Master Files.

6. Submit MD5 application (Form MD3): Once test results are in, apply online.

7. Prepare for audit: Engage with a notified body early.

By following these actionable steps, manufacturers and importers can streamline their journey to market access for TruncalOrthosis devices in India.

For personalized assistance, contact our regulatory experts to ensure your licensing process is seamless and compliant.