CDSCO License for Craniofacial bone screw, non- bioabsorbable, sterile

Introduction to Craniofacial Bone Screw and Its Regulatory Importance

Craniofacial bone screws, non-bioabsorbable and sterile, are critical implantable medical devices used primarily for fracture fixation in craniofacial and maxillofacial surgeries. Their role in pediatric reconstructive surgery, craniotomy flap fixation, and bone augmentation highlights their clinical significance. Due to their invasive nature and patient safety considerations, these devices are classified as Class C under India's medical device regulations, necessitating stringent regulatory compliance.

Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process is essential for manufacturers and importers aiming to market this device in India. With over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we understand the nuances involved in ensuring timely approvals while maintaining regulatory integrity.

CDSCO Regulatory Framework for Craniofacial Bone Screws (Class C)

The CDSCO classifies medical devices based on risk, with Class C representing moderate to high risk devices requiring central licensing authority approval. Craniofacial bone screws fall into this category due to their implantable nature and critical clinical application.

For Class C devices, the applicable manufacturing license is the MD9 license, granted by the Central Licensing Authority. Importers must apply for the MD15 license. Both licenses require comprehensive documentation, product testing, audits, and compliance with Indian medical device rules.

Risk Classification and License Requirements

• Device Risk Class: Class C (Moderate to High Risk)
• Manufacturing License: MD9 (Application Form MD7)
• Import License: MD15 (Application Form MD14)

Class C devices mandate a rigorous evaluation process including product testing, technical documentation review, and CDSCO audit inspections.

Manufacturing License Process (MD9) for Craniofacial Bone Screws

1. Test License (Form MD13): Initiate the process by applying for a test license, which takes approximately 1.5 to 2 months. This license allows for product testing in government-approved labs.
2. Product Testing: Conduct mandatory tests at CDSCO-approved testing laboratories to verify compliance with Indian standards. Reference the list of testing laboratories for approved facilities.
3. Document Compilation: Prepare the full dossier including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal along with all required documents.
5. CDSCO Inspection and Audit: The Central Licensing Authority will conduct a thorough inspection of your manufacturing site and quality management systems.
6. Query Resolution: Address any queries or deficiencies raised during audits promptly.
7. Grant of License (Form MD9): Upon satisfactory compliance, the MD9 license will be issued.

Manufacturing License Documents Required

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing facilities and equipment (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with Indian Essential Principles
• Risk Management File demonstrating conformity with risk standards (Risk Management)
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485:2016 preferred)

Import License Process (MD15) for Craniofacial Bone Screws

Importers of craniofacial bone screws must apply for the MD15 license with the Central Licensing Authority. The process typically takes 5 to 6 months and involves:

1. Document Preparation: Collate required documents including manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and device-related master files.
2. Application Submission: File the application on the CDSCO MD Online Portal.
3. Query Resolution: Respond to any clarifications raised by CDSCO.
4. License Grant: On successful review, the MD15 import license will be granted.

Import License Documents Required

• Valid Manufacturing License (MD9 or equivalent from foreign manufacturer)
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

Manufacturers should anticipate an overall timeline of 4 to 5 months for domestic production licenses and 5 to 6 months for import licenses, considering testing, audits, and document review.

Government Fees and Costs

• MD9 License Fees: Rs 50,000 per application + Rs 1,000 per product
• Test License (MD13): Typically included in application fees
• Import License (MD15) Fees:
  • Class C devices: $3,000 per site +$1,500 per product

Budgeting for these costs upfront is critical. Additional costs may include consultancy, testing lab fees, and audit-related expenses.

Common Challenges and Solutions

• Delayed Testing and Certification: Testing backlog in government labs can stall timelines. Mitigate by early booking and choosing labs from the CDSCO-approved list.
• Incomplete Documentation: Inadequate or inconsistent DMF or PMF submissions often lead to queries. Utilize expert consultation to prepare thorough, compliant files.
• Audit Non-Compliance: Manufacturing premises or QMS gaps can cause audit failures. Conduct internal audits and pre-inspection readiness assessments.
• Regulatory Changes: Stay updated with notifications such as File No. 29/MiscJ03/2020-DC (150) dated 23.8.2021, which can impact classification and license requirements.

Expert Consultation and Support

Our extensive experience in assisting over 500 companies positions us uniquely to guide you through the complexities of the CDSCO licensing process. From document preparation, audit readiness, to regulatory strategy, our expert consultants ensure efficient submissions and reduce approval timelines.

Access our detailed MD9 License Guide to understand step-by-step requirements and best practices.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the Class C status of your craniofacial bone screw to select the appropriate license.
2. Prepare Test License Application (MD13): Submit this first on the CDSCO MD Online Portal.
3. Engage with Approved Testing Laboratories: Schedule product testing early to avoid delays.
4. Compile Comprehensive Documentation: Focus on DMF, PMF, Risk Management, and QMS documents.
5. Submit Manufacturing License Application (MD9): After successful testing, apply for the manufacturing license.
6. Plan for CDSCO Audit: Prepare your facility and quality systems to meet CDSCO standards.
7. For Importers, Gather International Compliance Certificates and Apply for MD15 License.

Starting early and following a structured approach can make the CDSCO licensing journey smoother and faster. Reach out to our experts to kickstart your application and ensure your craniofacial bone screw meets all regulatory requirements to enter the Indian market seamlessly.