Get CDSCO License for Orthopaedic Medical Devices

We are one of India’s premier medical device consultants. Our team has extensive knowledge and expertise in CDSCO regulatory guidelines for medical devices. With our support, you can start your orthopaedic medical device business in India in a hassle-free manner. Moreover, the Pharmadocx Consultants team has set up the maximum number of orthopaedic medical device manufacturing facilities in north India. Our team will work relentlessly to ensure you secure the CDSCO license for orthopaedic medical devices in a seamless-manner.

What are Orthopaedic Medical Devices?

Orthopaedic medical devices are a wide range of devices used to stabilize and restore function in bones, joints, and other related structures. These tools and instruments are designed to diagnose, treat, and manage musculoskeletal conditions. Implants, instruments, and orthotics are the major types of orthopaedic medical devices. These orthopaedic medical devices have a vital role in supporting and enhancing an individual’s mobility, thereby improving their quality of life.

CDSCO Regulations for Orthopaedic Medical Devices

Central Drugs Standard Control Organization (CDSCO) aims to ensure the safety and efficacy of orthopaedic medical devices in India. Therefore, orthopaedic medical device manufacturers and importers have to be well-versed with the CDSCO regulations for orthopaedic medical devices. Moreover, securing the CDSCO license for orthopaedic medical devices is a mandatory requirement.

CDSCO Classification for Orthopaedic Medical Devices

Medical devices have been classified based on the potential risks associated with their use. Similar to other medical devices, orthopaedic devices have also been classified into the four CDSCO classes, A, B, C, and D. This medical device classification system has been formulated to simplify the CDSCO license application system.

Class B orthopaedic medical devices

• Intra osseous fixation wire
• Bone wire
• Bone cap
• Plates, clippers, screws
• Spinal fluid manometer
• Sterilization wrap
• Surgical drill and its attachment
• Ultrasonic cleaner for medical instruments
• Unilateral external fixation system
• Vacuum-powered body fluid suction apparatus
• Hip system instrument
• Bone cement accessories

Class D orthopedic medical device classes

• Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis
• Hip joint metal constrained cemented or uncemented prosthesis
• Intervertebral body fusion device
• Cervical artificial disc
• Hip joint metal/polymer constrained cemented or uncemented prosthesis
• Hip joint femoral (hemi-hip) metallic resurfacing 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

We have listed some examples of orthopaedic medical devices belonging to the different CDSCO classes. Use our free tool to check which CDSCO class your orthopaedic device belongs to.

CDSCO License for Orthopaedic Medical Devices

CDSCO license for manufacturing class C & D orthopaedic medical devices

MD 9 license is required to manufacture class C & D orthopaedic medical devices. An application has to be filed under Form MD-7. A fee of Rs. 50,000 for the manufacturing license and Rs. 1,000 for each distinct device is required.

CDSCO loan license for manufacturing class C & D orthopaedic medical devices

Manufacturers seeking to obtain a loan license for manufacturing class C & D orthopaedic medical devices need to apply using the Form MD 8. CDSCO will grant the approval via Form MD 10.

CDSCO test license to manufacture orthopaedic medical devices in India

MD-13 license is required to manufacture small quantities of devices for testing purposes. An application has to be filed under Form MD-12.

Documents Required for CDSCO License for Orthopaedic Medical Devices

We have enlisted the necessary supporting documents.

1. Cover letter
2. Organization identity proof
3. Sale Deed/Rent Deed of the Premises
4. Plant Master File
5. Device master file
6. Power of attorney
7. Building Layout with Dimension
8. Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.
9. Test License, if required for testing the orthopaedic medical device
10. Environmental regulation compliance documents
11. Certificate of analysis of 3 consecutive batches
12. ISO 13485 Certificate
13. TR6 challan
14. Quality assurance certificate

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Validity of the CDSCO License for Orthopaedic Medical Devices

CDSCO orthopaedic license is valid indefinitely. However, to maintain the validity, the license retention fee has to be paid every 5 years.

How to Overcome CDSCO License Application Challenges?

• Comply with all CDSCO regulations for orthopaedic medical devices.
• Ensure all documents are up-to-date and meet CDSCO’s guidelines.
• Promptly and accurately address CDSCO queries.
• Conduct regular internal reviews of the facility to avoid any pitfalls during CDSCO regulatory audits.

How can Pharmadocx Consultants Assist in Securing the CDSCO License for Orthopaedic Medical Devices?

• Expert guidance: We have extensive knowledge of the CDSCO regulations. Our team will help you select the appropriate CDSCO license for your product. Additionally, we will help you navigate through the CDSCO regulations for orthopaedic medical devices. Furthermore, we will help you fill out the CDSCO license application form.
• Setting up the manufacturing facility: We have set up the maximum number of orthopaedic medical device manufacturing facilities in north India. We will help you set up your facility per CDSCO regulatory guidelines. With our support, you will not face any regulatory obstacles while securing the CDSCO license.
• Document preparation service: We offer comprehensive document preparation service. Our team will not only help you prepare the necessary documents but also compile them per CDSCO guidelines.
• Query resolution support: In case CDSCO raises any query regarding the license application, we will help you promptly respond to it.
• End-to end service: Our support does not end with license application. We will provide support till you successfully secure the CDSCO orthopaedic medical device license. Moreover, we provide continued support for compliance with any updates in the CDSCO regulations.

Our Clients

Want to easily secure the CDSCO license for orthopaedic medical devices? Call/Whatsapp on 9996859227 or email at [email protected] to let us help you turn your medical device business dream into a licensed reality.