Medical Device License for Orthopaedic Implants
Orthopaedic implants are life-changing medical devices designed to replace, support, or enhance bones and joints—restoring mobility and improving quality of life for millions. In India, these devices range from low-risk surgical tools to high-risk, long-term implants such as hip and knee prostheses.
The Central Drugs Standard Control Organization (CDSCO) regulates all orthopaedic implants under the Medical Device Rules, 2017. Whether you manufacture or import, obtaining the correct CDSCO license is mandatory for legal market access, patient safety, and product credibility.
With over 25 years of experience and 500+ successful licenses, our team guides you through every regulatory step—ensuring your orthopaedic devices meet the highest standards of safety, quality, and compliance.

Key CDSCO Licenses for Orthopaedic Implants

MD5 Manufacturing License
- Test License (MD13)
- Product Testing
- Documentation
- Audit by Notified Body

MD9 Manufacturing License
- Test License (MD13)
- Product Testing
- Documentation
- CDSCO Audit

MD15 Import License
- Dossier Preparation
- Foreign Certificates
- Application Submission
- CDSCO Review
All Articles on Orthopaedic Implants
CDSCO License for Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Expert guidance on obtaining CDSCO MD9 license for Class C hip joint prosthesis, including timelines, costs, documentation, and practical tips for smooth regulatory approval.
CDSCO License for hip joint metal/composite semi-constrained cemented prosthesis
Comprehensive CDSCO licensing guide for Class C hip joint metal/composite semi-constrained cemented prosthesis, including timelines, costs, and expert insights.
CDSCO License for Hip joint metal/polymer constrained cemented or uncemented
Navigate the CDSCO licensing process for Class D Hip Joint Orthopaedic Implants with expert guidance on timelines, costs, documents, and practical tips from 25+ years of experience.
CDSCO License for Shoulder joint humeral (hemi- shoulder) metallic uncemented prosthesis.
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C shoulder joint humeral uncemented prosthesis, including timelines, costs, and documents.
CDSCO License for Wrist joint metal constrained cemented prosthesis
Navigate CDSCO licensing for Wrist Joint Metal Constrained Cemented Prosthesis with our expert guide on Class C device regulations, timelines, costs, and documentation.
CDSCO License for Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis
Expert guidance on obtaining CDSCO MD9 license for Shoulder Joint Constrained Cemented Prosthesis (Class C) with timelines, costs, and document insights.
CDSCO License for Knee joint femorotibial metal/composite semi-constrained cemented prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Knee Joint Femorotibial Semi-Constrained Prosthesis (Class C), with detailed timelines, costs, and document requirements.
CDSCO License for Hip joint metal/polymer constrained cemented or uncemented Prosthesis
Expert guide to obtaining CDSCO MD9 license for Hip Joint Metal/Polymer Constrained Prostheses, covering timelines, costs, documents, and practical steps for Class D orthopaedic implants.
CDSCO License for Bone Wire
Expert guide on obtaining CDSCO MD9 license for Bone Wire (Class C device) covering timelines, costs, documents, and practical steps for smooth market entry in India.
CDSCO License for Elbow joint metal/polymer semi-constrained cemented prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Elbow Joint Semi-Constrained Prostheses, with timelines, costs, and document checklists.
CDSCO License for Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class D Hip Joint Femoral prostheses with timelines, costs, and document insights.
CDSCO License for Pedicle screw spinal system
Expert guide to obtaining CDSCO MD9 manufacturing and MD15 import licenses for Pedicle Screw Spinal Systems, detailing timelines, costs, documents, and practical steps.
CDSCO License for Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
Expert guide to CDSCO MD9 license for Knee Joint Femorotibial Non-Constrained Cemented Prosthesis, covering timelines, costs, documents, and practical tips for Class C orthopaedic implants.
CDSCO License for knee joint patellofemorotibial metal/polymer
Expert guidance on securing CDSCO MD9 license for knee joint patellofemorotibial implants with practical steps, timelines, costs, and document checklists.
CDSCO License for Spinal interlaminal fixation orthosis
Expert guidance on obtaining CDSCO MD9 license for Spinal Interlaminal Fixation Orthosis, covering timelines, costs, documents, and practical steps for Class C orthopaedic implants.
CDSCO License for Wrist joint carpal scaphoid polymer prosthesis
Expert guidance on obtaining CDSCO MD9 license for Wrist Joint Carpal Scaphoid Polymer Prosthesis, covering timelines, costs, documents, and practical steps for Class C orthopaedic implants.
CDSCO License for Shoulder joint glenoid (hemi- shoulder) metallic cemented prosthesis
Expert guide to obtaining CDSCO MD9 license for Shoulder Joint Glenoid (Hemi-Shoulder) Metallic Cemented Prosthesis, detailing process, timelines, costs, and documents.
CDSCO License for elbow joint humeral (hemi- elbow) metallic uncemented prosthesis
Expert guidance on obtaining CDSCO MD9 license for Class C elbow joint humeral metallic uncemented prosthesis, including timelines, costs, and document requirements.
CDSCO License for Intervertebral body fusion device
Expert guidance on obtaining CDSCO MD9 license for Class D Intervertebral Body Fusion Devices, covering timelines, costs, documentation, and practical tips for orthopaedic implant manufacturers.
CDSCO License for Toe joint phalangeal (hemi- toe) polymer prosthesis
Expert guidance for obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C toe joint phalangeal polymer prosthesis, including timelines, costs, and documentation.
CDSCO License for Knee joint femorotibial metal/composite non-constrained cemented Prosthesis
Expert guidance on obtaining CDSCO MD9 license for Knee Joint Femorotibial Prosthesis, with timelines, costs, and document requirements for Class C orthopaedic implants.
CDSCO License for A hip joint (hemi- hip) acetabular metal cemented prosthesis
Get expert guidance on securing your CDSCO MD9 manufacturing license and MD15 import license for Class D hip joint acetabular metal cemented prostheses with timelines, costs, and document checklists.
CDSCO License for Sacroiliac joint fixation
Navigate CDSCO licensing for sacroiliac joint fixation devices (Class C) with expert timelines, costs, and document guidance for smooth market entry.
CDSCO License for Smooth or threaded metallic bone fixation fastener
Expert guide to obtaining CDSCO MD9 license for Smooth or threaded metallic bone fixation fasteners with detailed timelines, costs, and document requirements.
CDSCO License for Knee joint patellofemorotibial polymer/metal/pol ymer semi- constrained cemented prosthesis.
Expert guidance on obtaining CDSCO MD9 license for Class C Knee Joint Prosthesis with detailed timelines, costs, and document requirements for seamless market entry in India.
CDSCO License for elbow joint radial (hemi-elbow) polymer
Navigate the CDSCO licensing process for Class C elbow joint radial (hemi-elbow) polymer devices with expert insights on timelines, costs, and documentation for seamless approval.
CDSCO License for Shoulder joint metal/polymer/met al nonconstrained or semi- constrained porous-coated uncemented prosthesis
Expert guidance on obtaining CDSCO MD9 license for Shoulder Joint Orthopaedic Implants, covering timelines, costs, documents, and practical steps for Class C devices.
CDSCO License for Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis
Expert guidance on obtaining CDSCO MD9 license for Class C Knee Joint Tibial Metallic Resurfacing Prosthesis with clear timelines, costs, and document checklists.
CDSCO License for A Knee joint femorotibial metallic constrained cemented prosthesis is a device intended to be implanted to replace part of a knee Joint
Expert guidance on obtaining CDSCO MD9 license for your Class C Knee Joint Femorotibial Metallic Constrained Cemented Prosthesis with detailed timelines, costs, and documentation.
CDSCO License for hip joint metal constrained cemented or uncemented prosthesis
Expert guidance on obtaining CDSCO MD9 license for Class D hip joint metal constrained prostheses, detailing timelines, costs, documents, and practical tips for seamless approval.
CDSCO License for Finger joint metal/metal constrained cemented prosthesis
Comprehensive guide for obtaining CDSCO MD9 license for Finger Joint Metal/Metal Constrained Cemented Prosthesis, covering timelines, costs, documents, and practical insights.
CDSCO License for Shoulder joint metal/polymer semi-constrained cemented prosthesis
Expert guidance on CDSCO MD9 license for Shoulder Joint Cemented Prosthesis, detailing timelines, costs, documentation, and practical steps for Class C orthopaedic implants.
CDSCO License for Hip joint femoral (hemi-hip) metallic resurfacing prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class D Hip Joint Femoral Metallic Resurfacing Prosthesis with timelines, costs, and document checklists.
CDSCO License for Hip joint metal/ceramic/polymer semi- constrained cemented or nonporous uncemented prosthesis
Expert guidance on CDSCO MD9 license for Hip Joint Prosthesis Class C devices with timelines, costs, documents, and practical tips for successful approval in India.
CDSCO License for knee joint femoral (hemi-knee) metallic uncemented prosthesis
Expert guidance on CDSCO MD9 license for knee joint femoral metallic uncemented prosthesis, detailing timelines, documents, costs, and practical steps for Class C orthopaedic implants.
CDSCO License for Orthopedic implant & accessories
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Orthopedic Implants with detailed timelines, costs, and document checklists.
CDSCO License for Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis
Expert guidance on obtaining CDSCO MD9 license for Hip Joint Metal/Metal Semi-Constrained Prosthesis (Class D), covering timelines, costs, documents, and practical steps.
CDSCO License for hip joint metal/metal semi-" constrained, with an uncemented acetabular component, prosthesis
Expert guidance on obtaining CDSCO MD9 license for Class D hip joint metal/metal semi-constrained prosthesis, with detailed timelines, costs, and document requirements.
CDSCO License for Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Knee Joint Femorotibial Prosthesis with detailed timelines, costs, and documentation.
CDSCO License for Knee joint femorotibial metal/polymer constrained cemented Prosthesis
Navigate CDSCO licensing for Class C orthopaedic implants like Knee Joint Femorotibial Prosthesis with expert guidance on timelines, costs, and document requirements.
CDSCO License for Bone cap
Navigate the CDSCO licensing process for Bone Cap orthopedic implants (Class C) with our expert guidance on timelines, documents, costs, and practical steps.
CDSCO License for Knee joint femorotibial (uni- compartmental) metal/polymer porous-coated uncemented prosthesis
Navigate the CDSCO MD9 license process for Class C orthopaedic knee implants with expert guidance on timelines, costs, documents, and practical tips for market entry.
CDSCO License for Finger joint polymer constrained prosthesis
Navigate the CDSCO MD9 licensing process for Finger Joint Polymer Constrained Prosthesis with expert guidance on timelines, costs, documents, and practical steps.
CDSCO License for Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis.
Expert guidance on obtaining CDSCO MD9 and MD15 licenses for Class D Hip Joint Metal/Metal Semi-Constrained Prosthesis with timelines, costs, and documentation.
CDSCO License for shoulder joint metal/polymer non-constrained cemented prosthesis
Expert guidance on obtaining CDSCO MD9 license for shoulder joint metal/polymer non-constrained cemented prosthesis, including timelines, costs, and document requirements.
CDSCO License for Ankle joint metal/polymer non-constrained cemented prosthesis
Navigate the CDSCO license process for your Class C ankle joint prosthesis with our expert guidance—detailed timelines, costs, and documentation to streamline your market entry in India.
CDSCO License for Finger joint metal/metal constrained uncemented prosthesis
Expert guidance on obtaining CDSCO MD9 license for finger joint metal/metal constrained uncemented prosthesis, detailing timelines, costs, and document requirements for Class C orthopaedic implants.
CDSCO License for knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis
Navigate the CDSCO licensing process for Class C orthopaedic implants like knee joint patellofemoral prostheses with expert guidance on timelines, costs, and documentation.
CDSCO License for Ankle joint metal/composite semi-constrained cemented prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C ankle joint prostheses with detailed timelines, costs, and document requirements.
CDSCO License for Plates, clipersScrews
Get expert guidance on obtaining your CDSCO MD9 license for Class C orthopaedic implants like Plates, Clips, and Screws with clear timelines, costs, and document details.
CDSCO License for A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
Expert guidance on obtaining CDSCO MD9 license for Class D hip joint femoral prostheses with detailed timelines, costs, documentation, and practical insights.
CDSCO License for Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented Prosthesis
Expert guidance on obtaining CDSCO MD9 license for Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented Prosthesis, including timelines, costs, and document requirements.
CDSCO License for Wrist joint metal/polymer semi-constrained cemented prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C wrist joint prostheses with detailed timelines, costs, and documentation.
CDSCO License for Intra Osseous Fixation Wire
Navigate CDSCO licensing for Class C Intra Osseous Fixation Wires with our expert guide—detailing timelines, costs, document essentials, and practical steps for seamless market entry.
CDSCO License for Cortical Fixation Implant / rigidloop Adjustable Cortical Fixation System
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Cortical Fixation Implants with clear timelines, costs, and document requirements.
CDSCO License for Wrist joint polymer constrained prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C wrist joint polymer constrained prosthesis, with timelines, costs, and documentation.
CDSCO License for Elbow joint metal/polymer constrained cemented prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C elbow joint prostheses, with detailed timelines, costs, and document requirements.
CDSCO License for Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis
Expert CDSCO licensing guidance for Knee Joint Patellar (Hemi-Knee) Metallic Resurfacing Uncemented Prosthesis—Class C orthopaedic implant with detailed timelines, costs, and document requirements.
CDSCO License for Toe joint polymer constrained prosthesis
Expert guidance on obtaining CDSCO MD9 license for Class C Toe Joint Polymer Constrained Prosthesis, with timelines, costs, documents, and practical tips for smooth approval.
CDSCO License for Resorbable calcium salt bone void filler device
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Resorbable Calcium Salt Bone Void Filler Devices, including timelines, costs, and document requirements.
CDSCO License for Knee joint patellofemorotibial polymer/metal/met al constrained cemented prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Knee Joint Patellofemorotibial Prosthesis with detailed timelines, costs, and documents.
CDSCO License for Wrist joint carpal trapezium polymer prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Wrist Joint Carpal Trapezium Polymer Prosthesis, a Class C orthopaedic implant.
CDSCO License for Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class D Hip Joint Femoral Prosthesis, with timelines, costs, and document insights.
CDSCO License for Wrist joint carpal lunate polymer prosthesis
Expert guidance for obtaining CDSCO MD9 license for Wrist Joint Carpal Lunate Polymer Prosthesis (Class C), covering timelines, costs, documentation, and practical insights.
CDSCO License for Cervical Artificial Disc
Expert guide on obtaining CDSCO MD9 license for Cervical Artificial Disc (Class D orthopaedic implant) with detailed timelines, costs, and document requirements for smooth market entry.