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CDSCO License for Shoulder joint metal/polymer/met  al nonconstrained or semi- constrained porous-coated uncemented  prosthesis

Medical Device Information

Device Class
Class C

Intended Use

It is a device intended to be implanted to replace a shoulder joint

Manufacturing License
MD9
Import License
MD15
CDSCO License for Shoulder joint metal/polymer/met  al nonconstrained or semi- constrained porous-coated uncemented  prosthesis

Comprehensive Guide to CDSCO Licensing for Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis

Introduction: Understanding Your Shoulder Joint Prosthesis and Regulatory Importance

The Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis is a sophisticated orthopaedic implant designed to replace the shoulder joint, restoring mobility and function for patients with joint degeneration or injury. Given its critical role as an implantable device, this prosthesis falls under Class C risk category in India’s medical device regulatory framework. Compliance with CDSCO (Central Drugs Standard Control Organization) regulations is mandatory to ensure patient safety and market access.

At our firm, with over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we understand the unique regulatory challenges for Class C orthopaedic implants. This guide provides detailed, actionable insights on the entire licensing journey—from classification to license grant—helping manufacturers and importers strategically plan their entry into the Indian market.


CDSCO Regulatory Framework for Shoulder Joint Orthopaedic Implants

The CDSCO regulates medical devices in India under the Medical Device Rules, 2017, notified under the Drugs and Cosmetics Act. Orthopaedic implants like the shoulder joint prosthesis are classified as Class C devices due to their invasive nature and potential risk to patients.

Key regulatory steps are:

  • Product risk classification
  • Obtaining a Test License (Form MD13) for initial testing
  • Product testing by CDSCO-approved laboratories
  • Preparation and submission of manufacturing/import license application
  • Audit by CDSCO or notified bodies
  • Resolution of queries and final license issuance

This structured process ensures that the device meets safety, quality, and performance standards.


Risk Classification and License Requirements for Your Device

According to the notification 29/Misc/3/2017-DC (292) dated 06.06.2018, your shoulder joint prosthesis is classified as a Class C device. Class C devices:

  • Are medium to high-risk devices
  • Require approval from the Central Licensing Authority
  • Necessitate an MD9 manufacturing license (for domestic production) or an MD15 import license (for importers)

Due to the high-risk nature, the regulatory scrutiny is more intensive compared to Class A/B devices.


Manufacturing License Process for Class C Devices (MD9 License)

The MD9 license is the mandatory manufacturing license for Class C devices, granted by CDSCO’s Central Licensing Authority. The process involves several critical stages:

  1. Test License Application (Form MD13): Before full manufacturing approval, manufacturers must obtain a test license to produce samples for testing.
  2. Product Testing: Conduct tests at CDSCO-approved laboratories to validate safety and performance.
  3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, risk management files, and quality management system details.
  4. Application Submission (Form MD7): Submit the manufacturing license application via the CDSCO MD Online Portal.
  5. Audits and Inspections: CDSCO inspectors audit the manufacturing site and review technical files.
  6. Clarifications and Queries: Address any queries raised by CDSCO during the review.
  7. License Grant (Form MD9): Upon satisfaction, CDSCO grants the manufacturing license.

This entire process typically takes 4-5 months from start to finish.

For detailed guidance, refer to our MD9 License Guide.


Manufacturing License Documents Required for Shoulder Joint Prosthesis

For your specific device, ensure you prepare the following critical documents:

  • Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent
  • Proof of Ownership or Lease of Manufacturing Premises: Legal proof of manufacturing site
  • Technical Staff Credentials: Qualification and experience details of Responsible Technical Personnel
  • Fire and Pollution NOCs: Clearance certificates from respective authorities
  • Device Master File (DMF): Detailed description of the prosthesis design, materials, manufacturing processes, and validation (see our Device Master File Guide)
  • Plant Master File (PMF): Documentation of manufacturing environment, equipment, and quality systems (refer to Plant Master File Guide)
  • Essential Principles Checklist: Compliance with Indian Medical Device Rules
  • Risk Management File: Evaluation of risks in device design and usage, following ISO 14971 principles (Risk Management Guide)
  • Test Reports: From CDSCO-approved testing laboratories (find labs here)
  • Product Labels and Instructions for Use (IFU): Compliant with Indian regulations
  • Quality Management System Documents: ISO 13485 certification and internal procedures

Ensuring completeness and accuracy in these documents significantly reduces processing delays.


Import License Process for Shoulder Joint Prosthesis (MD15 License)

If you are an importer of this Class C orthopaedic implant, you must apply for an MD15 import license issued by the Central Licensing Authority.

The steps include:

  1. Document Compilation: Manufacturing license of the device, Free Sale Certificate from country of origin, ISO 13485:2016, CE certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution documents.
  2. Application Submission: File Form MD14 application through the CDSCO MD Online Portal.
  3. Review and Queries: Respond to any CDSCO queries.
  4. License Grant: Final approval results in MD15 license issuance.

This process generally takes 5-6 months.

For a deeper dive, visit our Import License Guide.


Timeline and Processing Duration

Process StepDuration (Approx.)
Test License (MD13)1.5 - 2 months
Product Testing1 - 1.5 months
Document Preparation1 month (parallel process)
Application Review & Audit1.5 - 2 months
Query Resolution0.5 months
Total Time for MD94 - 5 months

For importers, the MD15 license process takes approximately 5-6 months.

Planning your regulatory timeline accordingly prevents costly delays.


Government Fees and Associated Costs

Understanding fee structures helps budget accurately:

  • MD9 Manufacturing License:
    • Application Fee: ₹50,000
    • Per Product Fee: ₹1,000
  • MD13 Test License:
    • Typically included in application processing
  • MD15 Import License: Fees vary by device class, but for Class C devices, expect approximately:
    • Site Fee: $3,000
    • Product Fee: $1,500 per product

Additional costs include testing fees at government-approved labs and expenses related to audit readiness and documentation.


Common Challenges and Practical Solutions

Challenge 1: Incomplete or inconsistent documentation – Leads to multiple rounds of queries and delays.

Solution: Engage expert consultants early to perform document gap analysis and ensure compliance with CDSCO’s detailed requirements.

Challenge 2: Delays in product testing – Testing slots at government labs can be limited.

Solution: Schedule testing well in advance and consider pre-audit readiness to avoid bottlenecks.

Challenge 3: Audit non-compliance – Manufacturing site may not meet CDSCO or notified body standards.

Solution: Conduct internal mock audits and training for technical staff before CDSCO inspection.

Challenge 4: Misclassification or misunderstanding regulatory pathway – Can waste significant time and money.

Solution: Verify device classification with CDSCO guidelines or through expert consultation to select the correct license type.


Expert Consultation and Support

With our extensive experience guiding over 500 companies through CDSCO regulatory approvals, we provide tailored support including:

  • Classification validation and regulatory strategy
  • Documentation preparation and review
  • Coordination with notified bodies and testing laboratories
  • Pre-audit training and mock inspections
  • Query resolution and liaison with CDSCO officials

Our hands-on approach streamlines the complex licensing process, reducing timelines and improving approval success rates.


Getting Started with Your CDSCO License Application for Shoulder Joint Prosthesis

  1. Confirm Device Classification: Review official CDSCO notifications and your intended use.
  2. Prepare Essential Documents: Start compiling your Device Master File, Plant Master File, risk management, and other critical documents.
  3. Apply for Test License (MD13): Submit the test license application through the CDSCO MD Online Portal.
  4. Schedule Product Testing: Book time at CDSCO-approved testing laboratories early.
  5. Develop Quality Management System: Ensure ISO 13485 compliance and internal audit readiness.
  6. Engage a Notified Body: Identify appropriate notified bodies for audit support (see Notified Bodies List).
  7. Submit Manufacturing License Application: Once test license and test reports are completed, submit Form MD7 online.
  8. Prepare for Inspection: Conduct thorough internal audits and train your staff.
  9. Respond Promptly to Queries: Maintain clear communication with CDSCO authorities.

By following these pragmatic steps with expert guidance, your shoulder joint prosthesis manufacturing or import licensing process can proceed smoothly, enabling timely market entry in India’s growing orthopaedic device sector.

For personalized assistance or to kickstart your CDSCO licensing journey, contact our regulatory consulting team today.

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About the Author

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Tails Azimuth
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