Medical Device License for Internal Prosthetic Replacements
Internal prosthetic replacements are advanced medical devices designed to restore function and quality of life for patients. In India, these devices are regulated to ensure safety and efficacy.
The Central Drugs Standard Control Organization (CDSCO) regulates all internal prosthetic replacements 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 devices meet the highest standards of safety, quality, and compliance.

Key CDSCO Licenses for Internal Prosthetic Replacements

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 Internal Prosthetic Replacements
CDSCO License for Dural Graft Implant
Expert guidance on obtaining CDSCO MD9 license for Class C Dural Graft Implant, outlining timelines, costs, documentation, and practical tips for seamless regulatory approval in India.
CDSCO License for Intramedullary fixation rod
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Intramedullary Fixation Rods, including timelines, costs, and document checklists.
CDSCO License for Retinal implant
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class D retinal implants, with detailed timelines, costs, and document checklists.
CDSCO License for Endosseous dental implant abutment
Expert guide to obtaining CDSCO MD9 license for Endosseous dental implant abutments (Class C), detailing timelines, costs, documents, and practical regulatory insights.
CDSCO License for Sacculotomy tack (Cody tack)
Comprehensive guide for obtaining CDSCO MD9 manufacturing and MD15 import licenses for Sacculotomy Tack (Class C), including timelines, costs, documentation, and expert regulatory insights.
CDSCO License for Total temporomandibular joint prosthesis
Expert guidance on securing CDSCO MD9 license for Total Temporomandibular Joint Prosthesis (Class D), covering timelines, costs, documentation, and practical regulatory strategies.
CDSCO License for Cochlear implant
Expert guide for obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class D cochlear implants, with detailed timelines, costs, and document checklists.
CDSCO License for Breast implant
Expert guide for obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Breast Implants, detailing timelines, costs, documents, and practical tips.
CDSCO License for Implanted mechanical/hydrau lic urinary continence device
Expert guidance on obtaining CDSCO MD9 license for implanted mechanical/hydraulic urinary continence devices with detailed timelines, costs, and document requirements.
CDSCO License for Penile rigidity implant
Expert guidance on obtaining CDSCO MD9 license for Class C penile rigidity implants with detailed timelines, costs, document checklists, and practical regulatory insights.
CDSCO License for Hearing Prosthesis System
Navigate CDSCO Class C license for Hearing Prosthesis Systems with expert guidance on timelines, costs, documents, and practical steps for smooth approval.
CDSCO License for Fallopian tube prosthesis
Expert guidance on obtaining CDSCO MD9 license for Fallopian Tube Prosthesis, detailing timelines, costs, documents, and practical steps for Class C internal prosthetic devices.
CDSCO License for Mandibular implant facial prosthesis
Expert guidance on CDSCO MD9 license for mandibular implant facial prosthesis, detailing timelines, costs, documents, and practical steps for Class C internal prosthetic devices.
CDSCO License for Gluteus implants
Expert guidance on obtaining CDSCO MD9 license for Class C Gluteus Implants, detailing timelines, costs, documents, and practical steps for seamless market entry in India.
CDSCO License for Injectable implant for the treatment of vesicoureteral reflux
Expert guidance on obtaining CDSCO MD9 license for Injectable Implants (Class C) with detailed timelines, costs, documentation, and practical tips for seamless market entry.
CDSCO License for Calf implants
Expert guide on obtaining CDSCO MD9 license for Class C calf implants with detailed timelines, costs, and document requirements to smoothly enter the Indian medical device market.
CDSCO License for Glenoid fossa prosthesis
Expert guide for obtaining CDSCO MD9 license for Glenoid fossa prosthesis (Class D), detailing timelines, costs, documents, and practical tips to streamline your regulatory approval in India.
CDSCO License for Bone heterograft
Navigate the CDSCO licensing process for Class D Bone Heterograft implants with expert guidance on timelines, documentation, costs, and compliance to successfully enter the Indian market.
CDSCO License for Dental implant
Navigate the CDSCO licensing process for Class C dental implants with expert guidance on timelines, costs, documentation, and practical tips to ensure successful market entry in India.
CDSCO License for Auditory Brainstem Implant System
Expert guidance on obtaining CDSCO MD9 license for Auditory Brainstem Implant Systems, detailing timelines, costs, document requirements, and practical tips for Class D devices.
CDSCO License for Cardiovascular prosthetic devices
Expert guidance on CDSCO MD9 license for Class D cardiovascular prosthetic devices, detailing timelines, costs, documents, and practical steps for market entry in India.
CDSCO License for Vaginal stent
Comprehensive guide to CDSCO licensing for Vaginal Stent (Class C), detailing timelines, costs, document requirements, and expert tips for smooth market entry in India.
CDSCO License for Bio Patches
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Bio Patches, with detailed timelines, costs, and document requirements.
CDSCO License for Voice / laryngeal Prothesis
Expert guide to obtaining CDSCO MD9 license for Voice/Laryngeal Prosthesis (Class C) with detailed timelines, costs, documents, and practical insights for smooth regulatory approval.
CDSCO License for Aneurysm Implant (detachable coils/clips)
Navigate the CDSCO MD9 license process for high-risk Aneurysm Implants with expert guidance on timelines, documentation, costs, and practical compliance tips.
CDSCO License for Total ossicular replacement prosthesis
Expert guide on obtaining CDSCO MD9 license for Total Ossicular Replacement Prosthesis (Class D), detailing timelines, costs, documents, and practical regulatory insights.
CDSCO License for Bone grafting material
Expert guide to obtaining CDSCO MD9 license for Bone Grafting Material (Class C), covering timelines, costs, documents, and practical steps for streamlined approval.
CDSCO License for Endosseous dental implant
Expert guidance on obtaining CDSCO MD9 license for Class C Endosseous Dental Implants, with detailed timelines, costs, and document requirements for smooth regulatory compliance.
CDSCO License for Vascular graft/occluders/Cardiac Patches
Expert guidance on obtaining CDSCO MD9 license for Class D vascular grafts, occluders, and cardiac patches with detailed timelines, costs, and document requirements.
CDSCO License for A testicular prosthesis
Expert guidance on obtaining CDSCO MD9 license for Class D Testicular Prosthesis, covering timelines, costs, documentation, and practical tips for smooth regulatory approval.
CDSCO License for Keratoprosthesis
Expert guidance on obtaining CDSCO MD9 license for Class D Keratoprosthesis, including timelines, costs, documentation, and practical tips for smooth regulatory approval.
CDSCO License for Penile inflatable implant
Navigate CDSCO Class D licensing for penile inflatable implants with expert guidance on timelines, costs, documentation, and practical compliance strategies.
CDSCO License for Vascular embolization device
Expert guidance on securing CDSCO MD9 license for Class D vascular embolization devices, covering timelines, costs, documents, and practical steps for smooth market entry.
CDSCO License for Annuloplastyring
Navigate CDSCO licensing for Class C Annuloplasty Rings with expert guidance on timelines, costs, documentation, and practical tips to ensure smooth approval.
CDSCO License for Hernia mesh
Expert guide to obtaining CDSCO MD9 license for Class C Hernia Mesh devices, detailing timelines, costs, documents, and practical tips for seamless regulatory compliance.
CDSCO License for Ear, nose, and throat and facial synthetic polymer material or implant
Comprehensive guidance on obtaining CDSCO MD9 license for Class C Ear, Nose, and Throat synthetic polymer implants with timelines, costs, and expert tips.
CDSCO License for An interarticular disc prosthesis
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class D interarticular disc prostheses, with detailed timelines, costs, and documentation.
CDSCO License for Polymeric Surgical Mesh
Expert guidance on obtaining CDSCO MD9 license for Class C polymeric surgical mesh with detailed timelines, costs, documentation, and practical tips for seamless regulatory approval.
CDSCO License for Endolymphatic shunt
Comprehensive guide for obtaining CDSCO MD9 manufacturing and MD15 import licenses for Endolymphatic Shunt (Class C), detailing timelines, costs, and documentation.
CDSCO License for Mandibular condyle prosthesis
Expert guidance on obtaining CDSCO MD9 license for Mandibular Condyle Prosthesis (Class D), including timelines, costs, documents, and practical tips for smooth approval.
CDSCO License for Tracheal prosthesis
Navigate the CDSCO license process for Class C Tracheal Prosthesis with our expert guide—covering timelines, costs, documentation, and practical tips for successful approval.
CDSCO License for Eye sphere implant
Expert guidance on obtaining CDSCO MD9 license for Eye Sphere Implant (Class D) with detailed timelines, costs, document requirements, and practical tips for smooth approval.
CDSCO License for An endolymphatic shunt tube with valve
Comprehensive guide to obtaining CDSCO MD9 license for Class C endolymphatic shunt tube with valve, covering timelines, costs, documents, and expert tips for smooth approval.
CDSCO License for Tissue Expanders
Expert guide for obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Tissue Expanders, with timelines, costs, and document checklists.
CDSCO License for Artificial Urinary Sphincters implants
Expert guide to CDSCO MD9 license for Artificial Urinary Sphincter implants, covering timelines, costs, required documents, and practical tips for Class C device manufacturers and importers.