CDSCO License for Facial prosthesis

Comprehensive Guide to CDSCO Licensing for Facial Prosthesis (Class B Medical Device)

Facial prostheses, such as artificial substitutes for nose, eyes, eyebrows, and upper lip, play a critical role in oncology care by restoring facial appearance for patients. Given its medical significance and external application, it is classified as a Class B medical device under CDSCO regulations. Navigating the regulatory landscape efficiently is vital for manufacturers and importers aiming to launch this device in the Indian market.

With over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we provide an in-depth, practical walkthrough of the licensing process specific to facial prostheses.

CDSCO Regulatory Framework for Facial Prosthesis

Facial prostheses fall under the oncology category and are governed by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, India. The device is notified under File No. 29/Misc./03/2020-DC (153) — Part 1, dated 11.10.2022, ensuring it complies with updated regulatory standards.

The regulatory framework mandates that Class B devices like facial prosthesis require a manufacturing license (MD5) from the respective State Licensing Authority. The process includes quality checks, product testing, and audits to ensure patient safety and compliance with essential principles.

Risk Classification and License Requirements for Facial Prosthesis

• Risk Class: B (Low-Moderate risk)
• Applicable License: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority
• Typical Processing Time: 3-4 months

This classification means the device requires comprehensive documentation, testing, and audits but does not necessitate the more stringent central licensing procedures reserved for higher-risk devices.

Manufacturing License Process (MD5) for Facial Prosthesis

1. Apply for Test License (Form MD13): Before the MD5 license, a test license is mandatory to manufacture and test the device. This stage typically takes 1.5 to 2 months.
2. Product Testing: Conduct tests at CDSCO-approved testing laboratories to validate device safety and performance. Testing labs can be found on the CDSCO Testing Laboratories list.
3. Document Preparation: Compile comprehensive documents, including Device Master File, Plant Master File, risk management, and essential principles checklist.
4. Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit by an accredited notified body is required. Consult the list of notified bodies for selection.
6. Query Resolution: Respond promptly to any queries from CDSCO or the notified body.
7. Grant of License (Form MD5): Upon successful audit and document verification, the license is granted.

Manufacturing License Documents Required for Facial Prosthesis

Manufacturers must prepare and submit the following documents:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff and their Qualifications
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed product specifications, manufacturing processes, and quality controls. Our Device Master File guide offers practical insights.
• Plant Master File (PMF): Details about manufacturing facilities and equipment. See our Plant Master File guide for best practices.
• Essential Principles Checklist confirming compliance with CDSCO regulations
• Risk Management File highlighting hazard analysis and mitigation strategies
• Test Reports from approved labs
• Labeling and Instructions for Use (IFU) documents
• Quality Management System (QMS) documents (ISO 13485 preferred)

Import License Process (MD15) for Facial Prosthesis

If your business model involves importing facial prostheses instead of manufacturing locally, you must obtain an MD15 Import License from the Central Licensing Authority.

• No test license required for import
• Submit application using Form MD14 via the CDSCO MD Online Portal
• Provide essential documents such as Manufacturing License from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification, Device and Plant Master Files, and Wholesale Drug License

Typical processing duration for the MD15 license ranges from 5 to 6 months.

Import License Documents Required

• Valid Manufacturing License issued by the foreign competent authority
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale Drug License in India
• Company Constitution and supporting documents

Timeline and Processing Duration

Understanding that timelines can vary due to audit scheduling and query resolution delays, proactive preparation is essential.

Government Fees and Costs

• MD5 License (Class B):
  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500
• MD13 Test License: Included in the MD5 process

For import licenses (MD15), fees depend on device class and number of products.

Common Challenges and Solutions

• Challenge: Delays in product testing due to backlog at government labs.

  • Solution: Engage with multiple approved labs and plan testing well in advance.

• Challenge: Incomplete or inconsistent documentation leading to query delays.

  • Solution: Use checklists and expert consultation to ensure all documents are accurate and complete.

• Challenge: Audit non-conformities due to QMS gaps.

  • Solution: Implement ISO 13485 standards rigorously and conduct internal audits before the official audit.

• Challenge: Misclassification of device leading to incorrect license application.

  • Solution: Refer to the Medical Device Classification guide and consult experts to confirm correct device class.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized devices like facial prostheses. Our consultancy leverages decades of experience to provide:

• Customized document preparation and review
• Liaison with CDSCO and notified bodies
• Audit readiness training
• Risk management documentation support

This approach minimizes delays and maximizes approval success rates.

Getting Started with Your CDSCO License Application for Facial Prosthesis

1. Determine your licensing path: Confirm whether you are manufacturing domestically (MD5) or importing (MD15).
2. Register on the CDSCO MD Online Portal and create your account.
3. Start with the Test License (MD13) application if manufacturing.
4. Engage accredited testing laboratories early to schedule product testing.
5. Prepare and organize all required documents, including Device and Plant Master Files.
6. Schedule a notified body audit once test results and documents are ready.
7. Submit the MD5 or MD15 application with full documentation through the portal.
8. Respond promptly to any queries from CDSCO or auditors to avoid delays.

By following these precise steps and leveraging expert guidance, manufacturers and importers of facial prostheses can successfully navigate the CDSCO licensing process, ensuring timely market entry and compliance with Indian regulatory requirements.

For detailed assistance, refer to our specialized guides on the MD5 license process and import license process.

Feel free to contact us for tailored support and to begin your regulatory journey with confidence.