CDSCO License for A hip joint (hemi-  hip) acetabular metal cemented  prosthesis

CDSCO Licensing for Hip Joint (Hemi-Hip) Acetabular Metal Cemented Prosthesis – Class D Orthopaedic Implant

Manufacturers and importers of high-risk orthopaedic implants like the hip joint (hemi-hip) acetabular metal cemented prosthesis must navigate a stringent regulatory landscape in India. This device, classified as Class D due to its implantable nature and critical role in patient health, falls under the purview of the Central Drugs Standard Control Organization (CDSCO). With over 25 years of regulatory consulting experience and successful support to 500+ companies, we provide you a detailed roadmap to obtain your CDSCO manufacturing (MD9) and import (MD15) licenses efficiently.

Understanding the CDSCO Regulatory Framework for Class D Orthopaedic Implants

The hip joint acetabular prosthesis is notified under the Indian Medical Devices Rules (MDR) 2017, specifically referenced as Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. Given its implantable nature, it is categorized as a Class D device, requiring the highest level of regulatory scrutiny.

The CDSCO acts as the Central Licensing Authority for Class C and D devices, overseeing both manufacturing and import licensing.

Risk Classification and License Requirements

• Device Risk Class: D (High risk, implantable)
• Regulatory Route:
  • Manufacturing License: MD9 (Application Form MD7)
  • Import License: MD15 (Application Form MD14)

Class D devices require rigorous testing, audit inspections, and comprehensive documentation to ensure patient safety and product efficacy.

Manufacturing License Process (MD9) for Hip Joint Prosthesis

The manufacturing license process for Class D devices is centralized and typically spans 4-5 months. The process involves:

1. Test License Application (Form MD13):
   • Duration: 1.5 - 2 months
   • Purpose: Allows initial manufacturing and testing under supervision
2. Product Testing:
   • Manufacturers must submit samples to CDSCO-approved testing laboratories for biocompatibility, mechanical strength, and sterilization validation. Explore the list of testing laboratories authorized by CDSCO.
3. Documentation Preparation:
   • Compile Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents such as ISO 13485 certificates.
4. Application Submission:
   • Submit Form MD7 for MD9 license via the CDSCO MD Online Portal
5. Audit Inspection:
   • CDSCO inspectors conduct on-site audits of manufacturing facilities and QMS implementation.
6. Query Resolution:
   • Address any observations or queries raised during audit or document review promptly.
7. License Grant:
   • Upon satisfactory compliance, the MD9 license is granted.

Manufacturing License Documents Required for MD9

Prepare the following mandatory documents meticulously:

• Constitution of the Company (e.g., incorporation certificate, partnership deed)
• Proof of ownership or lease agreement of manufacturing premises
• Qualification and experience certificates of technical and quality staff
• Fire safety and pollution control clearances (NOC)
• Device Master File (DMF) outlining design, manufacturing process, and specifications. Our detailed Device Master File guide can assist you.
• Plant Master File (PMF) describing the manufacturing environment and equipment. Refer to our Plant Master File guide
• Essential Principles Checklist confirming compliance with Indian MDR
• Risk Management File documenting hazard analysis and mitigation strategies. Learn more about medical device risk management
• Test Reports from approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, including ISO 13485:2016 certification

Import License Process (MD15) for Hip Joint Prosthesis

Importers must obtain an MD15 license from the CDSCO Central Licensing Authority. The process generally takes 5-6 months and includes:

1. Document Preparation:
   • Compile manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate if applicable
   • Prepare Device Master File, Plant Master File, and Wholesale License
2. Application Submission:
   • Submit Form MD14 on the CDSCO MD Online Portal
3. Query Resolution:
   • Respond to any queries from CDSCO promptly
4. License Grant:
   • MD15 import license is issued upon approval

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 certification
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale license for importers
• Company Constitution documents

Timeline and Processing Duration

Proactively ensuring document completeness and prompt query responses can reduce processing delays.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application fee: Rs 50,000
  • Per product fee: Rs 1,000

• MD15 Import License:

  • Class D devices: USD 3,000 per site + USD 1,500 per product

Additional costs include fees for testing at accredited labs and audits by CDSCO inspectors.

Common Challenges and Solutions

• Incomplete Documentation:
  • Solution: Use comprehensive checklists and expert review before submission.
• Delayed Testing Reports:
  • Solution: Schedule testing early with CDSCO-approved labs.
• Audit Non-compliance:
  • Solution: Conduct internal audits aligned with ISO 13485 and MDR requirements.
• Query Management Delays:
  • Solution: Assign a dedicated regulatory liaison for timely communication.

Expert Consultation and Support

Navigating CDSCO requirements for Class D orthopaedic implants demands expertise. Our team has guided over 500 manufacturers and importers through license approvals, minimizing rejections and delays. We assist with:

• Tailored document preparation including DMF and PMF
• Liaison with testing labs and notified bodies
• Audit readiness and mock inspections
• Query resolution and compliance strategies

Getting Started with Your CDSCO License Application

1. Determine your licensing pathway: For manufacturing, plan for MD9 license application; for import, prepare for MD15.
2. Gather required documents: Leverage our guides on Device Master File and Plant Master File to build comprehensive files.
3. Initiate test license application: Submit Form MD13 to begin manufacturing under supervision and product testing.
4. Engage with notified bodies and testing labs early: Consult the list of notified bodies to schedule your mandatory audits.
5. Submit applications via the CDSCO MD Online Portal: Ensure all forms (MD7 for MD9, MD14 for MD15) are correctly filled and uploaded.
6. Prepare for audits: Conduct internal mock audits to ensure compliance.
7. Respond promptly to department queries: Expedite clarifications to avoid processing delays.

By following these practical steps and leveraging expert support, manufacturers and importers of hip joint acetabular metal cemented prostheses can confidently navigate the CDSCO licensing process and bring their life-enhancing devices to the Indian market.

For personalized assistance, contact our regulatory team to schedule a consultation and start your CDSCO application journey today.