CDSCO License for Therapeutic scrotal support.

Introduction to Therapeutic Scrotal Support and Its Regulatory Importance

Therapeutic scrotal support is a Class A medical device designed to provide medical support to the scrotum, aiding patient comfort and recovery in various clinical scenarios. Classified under General Hospital or Orthopaedic Instruments, this device is vital for post-surgical care, sports injuries, and other urological conditions. As a medical device intended for therapeutic use, obtaining the appropriate CDSCO license is mandatory to ensure compliance with Indian regulatory standards and to guarantee patient safety.

Navigating the regulatory landscape for medical devices in India can be complex, especially for first-time manufacturers or importers. With over 25 years of experience assisting more than 500 companies, we provide you with a detailed roadmap to secure your CDSCO MD5 manufacturing license efficiently.

CDSCO Regulatory Framework for Therapeutic Scrotal Support

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Therapeutic scrotal support falls under Class A, the lowest risk category, which simplifies the regulatory process compared to higher-risk devices.

The regulatory steps for Class A devices include obtaining a Test License (MD13), conducting product testing at government-approved labs, and finally securing the Manufacturing License (MD5) from the State Licensing Authority.

Risk Classification and License Requirements for Therapeutic Scrotal Support

• Risk Classification: Class A (Low Risk)
• Regulatory Authority: State Licensing Authority
• License Type: MD5 Manufacturing License (Application Form MD3)
• Notification Reference: 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022

Class A devices benefit from a streamlined process but still require strict adherence to quality and documentation standards to ensure compliance.

Manufacturing License Process (MD5) for Class A Therapeutic Scrotal Support

The manufacturing license process for your device involves several key stages:

1. Test License Application (Form MD13): Submit an application for a test license through the CDSCO MD Online Portal. This license permits you to manufacture the device for testing purposes.
2. Product Testing: Conduct product testing at one of the government-approved testing laboratories. Testing typically takes 4-6 weeks.
3. Documentation Preparation: Compile all necessary documents, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. Application for Manufacturing License (Form MD3): Apply for the MD5 license on the CDSCO portal.
5. Audit by Notified Body: Engage a notified body from the official list for a mandatory audit of your manufacturing facility and processes.
6. Queries and Compliance: Address any queries or observations raised by the CDSCO or the notified body.
7. Grant of License: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license.

The entire process typically takes 3 to 4 months.

Manufacturing License Documents Required for Therapeutic Scrotal Support

You must prepare and submit the following documents:

• Company Constitution: Proof of legal status (e.g., incorporation certificate, partnership deed).
• Proof of Ownership or Lease of Premises: Valid property documents.
• Technical Staff Details: Qualification and experience certificates of the technical personnel.
• Fire NOC and Pollution Control NOC: Compliance certificates from local authorities.
• Device Master File (DMF): Detailed device description, design, manufacturing process, and specifications. Our comprehensive Device Master File guide can assist you.
• Plant Master File (PMF): Description of manufacturing facilities and quality systems. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist: Demonstrating compliance with applicable safety and performance requirements.
• Risk Management File: Detailed risk analysis and mitigation strategies for the device, aligned with ISO 14971. Learn more about Risk Management.
• Test Reports: From approved laboratories confirming product safety and performance.
• Labels and Instructions for Use (IFU): Drafts and samples.
• Quality Management System (QMS) Documents: Evidence of ISO 13485 certification or equivalent quality system.

Import License Process (MD15) for Therapeutic Scrotal Support

While this device is Class A, if you plan to import it into India, you require an MD15 import license granted by the Central Licensing Authority.

The process involves:

• Document preparation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate, device and plant master files, wholesale license, and company constitution.
• Application submission on the CDSCO portal using Form MD14.
• Resolution of any regulatory queries.
• License issuance typically within 5-6 months.

For detailed guidance, consult our Import License guide.

Import License Documents Required

• Valid manufacturing license from the exporting country
• Free Sale Certificate
• ISO 13485:2016 certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale license in India
• Company Constitution documents

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months

Government Fees and Costs

• Test License Fee (MD13): Approximately Rs. 5,000 (varies by state)
• MD5 Manufacturing License Fees: Rs. 5,000 per application plus Rs. 500 per product
• Notified Body Audit Fees: Variable, typically Rs. 50,000 to Rs. 1,00,000 depending on scope
• Testing Laboratory Fees: Varies based on the number and type of tests

Budgeting for these costs upfront helps avoid delays due to financial constraints.

Common Challenges and Solutions

• Delays in Test License Approval: Proactively prepare complete and accurate documentation for MD13 to expedite approval.
• Testing Delays: Schedule tests early and select accredited laboratories with availability.
• Audit Non-Compliance: Conduct internal mock audits to identify gaps before the notified body visits.
• Document Gaps: Maintain updated Device and Plant Master Files and QMS documentation to quickly respond to queries.

Practical Tip: Engage with a notified body early in the process to understand specific audit expectations.

Expert Consultation and Support

With our extensive experience, we help you navigate these regulatory complexities by:

• Preparing and reviewing your documentation to meet CDSCO standards
• Coordinating with notified bodies and testing laboratories
• Providing training on risk management and quality systems
• Managing application submissions and follow-ups on the CDSCO MD Online Portal

Our tailored support reduces approval timelines and increases the likelihood of first-time approval.

Getting Started with Your CDSCO License Application for Therapeutic Scrotal Support

1. Assess Your Manufacturing Setup: Verify your facility’s compliance with GMP and readiness for audit.
2. Gather Documentation: Begin compiling your Device Master File, Plant Master File, and QMS records.
3. Apply for Test License (MD13): Submit your application through the CDSCO MD Online Portal to start the process.
4. Engage a Notified Body: Select a notified body from the official list of notified bodies for your audit.
5. Plan Product Testing: Coordinate testing with accredited labs early to avoid bottlenecks.
6. Prepare for Audit: Conduct internal reviews and training to ensure compliance.
7. Submit MD5 Application: Once tests are complete and documents are ready, apply for the manufacturing license.

Starting early and following these steps methodically will position your therapeutic scrotal support device for successful CDSCO licensing, enabling you to confidently enter the Indian medical device market.