Orthopaedic Implant Registration

Are you an importer or manufacturer of Implant devices then you must know about CDSCO orthopaedic implant registration. This one is the mandatory license for the manufacturing of orthopaedic implants. Because these products are categorized as medical devices and regulated by the Medical Device Rules, 2017, if you are willing to manufacture, import, sell, and distribute orthopaedic implants then you must have a medical device license. Your licenses are (MD 5, MD 9, MD 15, or MD 42). It applies to all orthopaedic implant devices of Class B, Class C, and Class D.

Who Authorizes License For Orthopaedic Implant In India?

The CDSCO (Central Drugs Standard Control Organization) is the licensing authority that provide certificate for Class C & D. On the other side the state licensing authority is the authority to grant license for the Class A & B for the Orthopaedic implant medical device.

What Is The Requirement Of CDSCO Orthopaedic Implant Registration & License? 

If you are willing to manufacture orthopaedic implant medical devices then you must know about the following points:-

  • You must have the MD 5 license from the state licensing authority for the manufacturing of Class A And B Orthopaedic Implant Medical Device.
  • If you want to manufacture class C orthopaedic implant in India then you have to obtain MD 9 license from CDSCO.
  • MD 15 import license CDSCO is necessary if you want to import Orthopaedic implant devices.

How To Apply For Orthopaedic Implant Registration & License In India? 

To apply for the registration of Orthopaedic implant devices license in India follow the mentioned steps:-

  1. Register your organization in CDSCO’s SUGAM Portal.
  2. Fill all the necessary information as per the mentioned application and submit them through CDSCO’s online SUGAM Portal.
  3. Upload the necessary documents and make the payment.
  4. Your application will be reviewed by the CDSCO team. If it meets the CDSCO requirements then your application will level and proceed to the company audit.
  5. The CDSCO team will conduct an audit of your manufacturing area. If the audit team finds any kind of NC (Non-Conformance) you have to apply to the NC closure report.
  6. When they find that all the conditioned are full fill the CDSCO Will grant the license.

What Is The Fee for CDSCO Orthopaedic Implant Registration and License in India? 

The fees of the CDSCO orthopaedic implant registration and license is depends on the class of the products. If you are applying for the class C & D then you have to pay a limited fee. The registration for Class A is costly. You can connect with the Medical Device Registration consultant team on 9891998002 for fees.

What Is The Validity Of CDSCO Orthopaedic Implant Registration? 

The validity of CDSCO Orthopaedic Implants license is valid for lifetime. Only you have to pay a government fee after 5 years.

List Of Documents Required For the CDSCO Orthopaedic Implant Registration

when you are going to apply for the CDSCO Orthopaedic Implant Registration license in India then you have to attach the following documents:-

  •  Identity Proof Of Organization – You have to attach the an organization identity proof such as memorandum of Association, list of partners and directors, UDYAM Aadhar, or PAN Card.
  • Sale Or Rent Deep Of Area – You have to attach the legal document of the manufacturing premises of medical devices.
  • Master File Of Plant or Site – In this file the whole information is mentioned about the layout of manufacturing facility, equipment and processes you are using to manufacture medical devices.
  • Layout & Dimensions of Products – The documents carry the information of the medical faculty, dimension of each room and area of the equipment where product is placed.
  • ISO 13485 Certificate and Previous Audit Reports – This certificate shows that the medical device and the faculty meets the International standard for quality management systems.
  • Qualified Team For Manufacturing and Testing Devices – You have a qualified and experienced staff who can manufacture and test medical device.
  • Device Master File – Attach the device master file application in which the detailed information is mentioned about the medical device, about its design, process and testing procedure.
  • Check The Environmental Requirements – You have to comply with the cleanliness of the premises of the medical device manufacturing.
  • Certificate of Analysis of 3 Consecutive Batches – These certificate shows that you have qualified the 3 batches of medical devices you manufactured.

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.

Why You Choose Us For The CDSCO Registration Of Orthopaedic Implants? 

You can choose us because we provide expert guidance at a budget cost. You only have to connect with us once and we will provide expert solution for medical device registration. We are established in this business since last 5 years and eal with multiple well named company in India.

FAQS

Who Need To Register For CDSCO?

All those who are willing to regulate the medical device from one country to another must need CDSCO Registration in India.

How Do I Get A CDSCO Certificate?

To geta CDSCO license you have to submit an application in CDSCO office with the required documents.