CDSCO Orthopaedic Implant Registration and License in India
Are you a manufacturer or importer of Orthopaedic Implants? These Orthopaedic Implants are categorized as medical devices and are regulated by the Medical Device Rules, 2017.
Licensing authorities for Orthopaedic Implants in India
The Central Drugs Standard Control Organization (CDSCO) ) is the licensing authority for Class C and Class D Orthopaedic Implants and the State Licensing Authority is the licensing authority for Class A and Class B Orthopaedic Implants in India.
List of Orthopaedic Implants Classified as “Class B” by the CDSCO
- Intra Osseous Fixation Wire
- Bone Wire
- Bone cap
- Plates, Clipers Screws
List of Orthopaedic Implants Classified as “Class C” by the CDSCO
- Cortical Fixation Implant / rigidloop Adjustable Cortical Fixation System
- Intervertebral Body Fusion Device / Fuse Spinal System
- Orthopedic implant & accessories
- Pedicle screw spinal system
- Ankle joint metal/composite semi-constrained cemented prosthesis
- Ankle joint metal/polymer non-constrained cemented prosthesis
- Elbow joint metal/polymer constrained cemented prosthesis
- Elbow joint metal/polymer semi-constrained cemented prosthesis
- elbow joint radial (hemi-elbow) polymer
- Elbow joint humeral (hemi- elbow) metallic uncemented prosthesis
- elbow joint humeral (hemi- elbow) metallic uncemented prosthesis
- Finger joint metal/metal constrained uncemented prosthesis
- Finger joint metal/metal constrained cemented prosthesis
- Finger joint polymer constrained prosthesis
- hip joint metal/composite semi-constrained cemented prosthesis
- Hip joint metal/ceramic/poly mer semi- constrained cemented or nonporous uncemented prosthesis
- Hip joint metal/polymer/met al semi-constrained porous-coated uncemented prosthesis.
- A knee joint femorotibial metallic constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint
- Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis
- Wrist joint carpal lunate polymer prosthesis
- Wrist joint metal/polymer semi-constrained cemented prosthesis
- Wrist joint metal constrained cemented prosthesis
- Wrist joint polymer constrained prosthesis
- Wrist joint carpal trapezium polymer prosthesis
- Wrist joint carpal scaphoid polymer prosthesis
- Smooth or threaded metallic bone fixation fastener
- Sacroiliac joint fixation
- Resorbable calcium salt bone void filler device
- Spinal interlaminal fixation orthosis
- Toe joint polymer constrained prosthesis
- Shoulder joint humeral (hemi- shoulder) metallic uncemented prosthesis.
- Shoulder joint glenoid (hemi- shoulder) metallic cemented prosthesis
- Shoulder joint metal/polymer/met al nonconstrained or semi-constrained porous-coated uncemented prosthesis
- Shoulder joint metal/polymer semi-constrained cemented prosthesis
- shoulder joint metal/polymer non-constrained cemented prosthesis
- Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis
- Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis
- knee joint femoral (hemi-knee) metallic uncemented prosthesis
- knee joint patellofemorotibial metal/polymer
- Knee joint patellofemorotibial polymer/metal/pol ymer semi-constrained cemented prosthesis.
- Knee joint patellofemorotibial polymer/metal/met al constrained cemented prosthesis
- knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis
- Knee joint femorotibial (uni- compartmental) metal/polymer porous coated uncemented prosthesis
- Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis
- Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
- Knee joint femorotibial metal/polymer constrained cemented prosthesis
- Knee joint femorotibial metal/polymer constrained cemented prosthesis
- Knee joint femorotibial metal/composite semi-constrained cemented prosthesis
- Knee joint femorotibial metal/composite non-constrained cemented prosthesis
- Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
- Spinal intervertebral body fixation orthosis
List of Orthopaedic Implants Classified as “Class D” by the CDSCO
- Intervertebral body fusion device
- hip joint metal constrained cemented or uncemented prosthesis
- Hip joint metal/polymer constrained cemented or uncemented prosthesis
- Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
- hip joint metal/metal semi- constrained, with an uncemented acetabular component, prosthesis
- Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis
- hip joint metal constrained cemented or uncemented prosthesis
- Cervical Artificial Disc
- Hip joint metal/polymer constrained cemented or uncemented prosthesis
- Hip joint femoral (hemi-hip) metallic resurfacing prosthesis
- A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
- A hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis
- Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
- A hip joint (hemi- hip) acetabular metal cemented prosthesis
- Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Are You Looking for CDSCO Orthopaedic Implant Registration and License in India to Manufacture and Import in India?
Contact MedDev Experts today! We have a team of experienced professionals who can help you navigate the complex regulatory process and get your license approved.
CDSCO Orthopaedic Implant Registration and License Requirement:
- To manufacture Class A and Class B Orthopaedic Implants in India, you must obtain the MD 5 License from the State Licensing Authority.
- To manufacture Class C Orthopaedic Implants in India, you must obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO).
- To import Orthopaedic Implants into India, you must obtain the MD 15 Import License from the CDSCO.
Requirements for CDSCO Orthopaedic Implants Registration and License in India
- Class A and Class B devices: MD 5 License from the State Licensing Authority
- Class C devices: MD 9 License from the CDSCO
- Import: MD 15 Import License from the CDSCO
Fee for CDSCO Orthopaedic Implant Registration and License in India
- Class A or Class B: ₹ 5,000/- for manufacturing license, ₹ 500/- for each distinct device.
- Class C or Class D: ₹ 50,000/- for manufacturing license, ₹ 1,000/- for each distinct device.
Validity of CDSCO Orthopaedic Implant Registration and License
- CDSCO licenses for Orthopaedic Implants are valid indefinitely, as long as the retention fee is paid every 5 years.
How to Apply Online for CDSCO Orthopaedic Implant Registration and License to Manufacture or Import in India
- Step 1: Enroll your organization on CDSCO’s SUGAM Portal.
- Step 2: Fill in the respective applications and submit them through CDSCO’s online SUGAM Portal.
- Step 3: Upload the necessary documents and make the required payment.
- Step 4: Your application will be scrutinized by the CDSCO Team. If it meets the requirements, it will proceed to a quality management system compliance audit.
- Step 5: The Team will conduct an audit at your manufacturing premises. If any Non-Conformance (NC) is identified, you will be required to submit an NC closure report.
- Step 6: Once all the conditions are met, CDSCO will grant the license.
Deadline for Obtaining CDSCO Orthopaedic Implant Registration and License in India
The deadline for obtaining CDSCO Orthopaedic Implant Registration and License in India is October 1, 2022 for Class A and Class B devices, and September 30, 2023 for Class C and Class D devices.
List of Documents for Obtaining Orthopaedic Implants Manufacturing Licenses in India
- Organization identity proof: This could be the Memorandum of Association, List of Directors or Partners, UDYAM Aadhar, or PAN card.
- Sale Deed / Rent Deed of the Premises: This document proves that you have legal ownership of the premises where you will be manufacturing the medical devices.
- Plant or Site Master File: This file contains information about the layout of your manufacturing facility, as well as the equipment and processes you will be using.
- Building Layout with Dimension: This is a detailed drawing of your manufacturing facility, showing the dimensions of each room and the location of all equipment.
- ISO 13485 Certificate and Previous Audit Reports: This certificate shows that your manufacturing facility meets international standards for quality management systems.
- Competent Technical Staff for Manufacturing and Testing of Devices: You must have a team of qualified and experienced staff who can manufacture and test your medical devices.
- Device Master File: This file contains detailed information about each medical device you will be manufacturing, including its design, manufacturing process, and testing procedures.
- Test License, if any: If you need a license to test your medical devices, you must obtain it before you can start manufacturing them.
- Compliance with the environmental requirements: You must comply with all applicable environmental regulations, such as those related to cleanrooms for manufacturing the devices.
- Certificate of Analysis of 3 Consecutive Batches: This certificate shows that the first 3 batches of medical devices you manufactured meet the required quality standards.
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