How to Get CDSCO License for Implantable Medical Device?

Implantable medical devices are surgically or medically introduced entirely or partially into the human body. They are intended to remain there after the procedure. These specialized devices serve critical medical purposes, such as supporting, replacing, or augmenting damaged anatomical structures. Additionally, they can be used to deliver targeted medications or continuously monitor vital physiological functions. They remain in constant contact with internal tissues and bodily fluids over a long duration or permanently. Hence, they have to be strictly regulated. CDSCO has laid down stringent regulatory guidelines for implantable medical devices in India for patient safety and improved patient outcome. Moreover, securing CDSCO license for implantable medical device is a mandatory requirement.

CDSCO regulations for implantable medical devices

Implantable medical devices are life-sustaining or life-supporting systems that operate in direct contact with vital organs. Any mechanical failure, material degradation, or biological rejection poses an immediate, life-threatening danger to the patient. As these devices are surgically and permanently embedded within the human body, correcting an adverse event requires invasive revision surgery, escalating the clinical risks. Hence, they are placed under high-risk classification. Rigorous regulatory scrutiny, including comprehensive clinical trials and centralized auditing, is mandatory. This is necessary to verify long-term biocompatibility, mechanical durability, and operational reliability before these devices reach a patient. Therefore, strict CDSCO regulations for implantable medical devices are in place. Manufacturers and importers are expected to comply with CDSCO implantable medical device regulations.

CDSCO class for implantable medical device

CDSCO has formulated the medical device classification system to simplify the CDSCO medical device license application process. The CDSCO class will determine the CDSCO license type and license application pathway.  The CDSCO class for implantable medical device will determine the CDSCO license required.

Implantable medical devices fall under Class C (moderate to high risk) or Class D (high risk). The specific class of the implantable medical device depends on the device’s invasiveness and potential danger to the patient. The CDSCO class will determine the CDSCO license for implantable medical device.

• Class C (Moderate-High Risk): Devices that are critically important but may not be permanently implantable or life-supporting. Examples: Orthopedic implants (e.g., bone plates/screws), breast implants, and spinal cages.
• Class D (High Risk): Life-supporting or life-sustaining devices, or devices that are highly invasive and directly impact vital bodily functions. Examples: Cardiac stents, pacemakers, heart valves, and implantable cardioverter-defibrillators

CDSCO license for implantable medical device

CDSCO license for manufacturing implantable medical device in India

• Manufacturing license: For manufacturing implantable medical device in India, a MD 9 license will be required. The applicant will have to use MD 7 to apply for a license to manufacture, sell, and distribute implantable medical device in India. The license to manufacture implantable medical device for sale and distribution in India will be granted under MD 9.
• Loan license: A loan license permits a company without a factory and facility to manufacture medical devices. With the loan license, the company can use the manufacturing facility of another company that is manufacturing the same medical device. The applicant will have to use MD 8 to apply for a loan license for manufacturing implantable medical device. Loan license to manufacture implantable medical device without a facility and factory will be granted under MD 10.

CDSCO license for importing implantable medical device into India

• CDSCO MD 15: To import implantable medical device into India, CDSCO MD 15 has to be secured from the CDSCO. The application for CDSCO MD15 license has to be filed on Form MD 14. The license to import implantable medical device will be granted on MD15 license.

Validity of CDSCO license for implantable medical device in India

The CDSCO license for implantable medical device remains valid indefinitely. However, a license retention fee has to be paid every 5 years to maintain the license validity.

Documents required for securing CDSCO license for implantable medical device in India

An overview of the documents required for securing CDSCO license for implantable medical device in India.

1. Covering letter
2. Organization identity proof, such as memorandum of association, list of directors or partners, UDYAM Aadhar, or PAN card.
3. Sale deed/rent deed of the premises proving the legal ownership of the medical device manufacturing facility.
4. Facility layout with dimension. A detailed drawing of the medical device manufacturing facility with the dimensions of each room and the location of all equipment.
5. ISO 13485 certificate
6. Plant master file containing information about the layout of the facility.
7. Device master file contains detailed information about the device, including its design, manufacturing process, testing procedures, and validation
8. Documents demonstrating compliance with the environmental requirements
9. Test license for the implantable medical device, if required
10. Details and qualification of technical staff who will manufacture and test the medical devices
11. Free sale certificate for CDSCO implantable medical device import license
12. Certificate of analysis demonstrating the device meets the required quality standards

We have provided an overview of the documents required for securing CDSCO implantable medical device license in India. Feel free to get in touch for a detailed list of documents required for CDSCO implantable medical device license application. Additionally, we will help prepare and compile the documents per CDSCO guidelines. Our document preparation service will ensure all the documents are prepared per the CDSCO requirements.

Application process for CDSCO license for implantable medical device

We have provided a step-by-step guide on how to apply for CDSCO license for implantable medical device in India.

1. Portal login: Sign in or login to SUGAM, the CDSCO online license application portal.
2. Form filling: Fill the application form applicable to your license requirement.
3. Document submission: Prepare and upload essential supporting documents required for license application.
4. Fee payment: Pay the necessary CDSCO license application fee, which will depend on the device’s classification.
5. Application confirmation: Once all documents are submitted and fees are paid, you will receive an application number. This will confirm successful submission.
6. Application review: CDSCO will meticulously review the application and all attached documents.
7. CDSCO queries: If there are queries or discrepancies, CDSCO will reach out for clarification or additional information.
8. Query response: CDSCO queries have to be promptly and accurately addressed. Submit any necessary supporting documents through the portal.
9. Facility audit and inspection: CDSCO officials will audit your factory for regulatory compliance.
10. Review: CDSCO will once again review and comment on the justifications and documents. If everything aligns with the regulations, the officials will move forward with the application.
11. License grant: Once all criteria are satisfied, the CDSCO license for implantable medical device in India will be granted.

Pharmadocx Consultants: Your trusted ally for CDSCO implantable medical device license application

CDSCO implantable medical device license application process can be a tricky task. The process requires knowledge of the CDSCO regulatory guidelines. CDSCO implantable medical device license application process is cumbersome requiring extensive document preparation and CDSCO query response, if needed.

We at Pharmadocx Consultants have extensive expertise and knowledge of the CDSCO medical device license application process. Feel free to contact us at [email protected] or call/Whatsapp on 9996859227 for a smooth CDSCO implantable medical device license application journey. Our comprehensive support covers everything from document preparation to application submission. Additionally, we provide CDSCO query response support and mock audit service. Our mock audit service will identify areas of non-conformity and provide steps to overcome the shortcomings. Moreover, our support does not end with license application. We provide continuous compliance and post licensing support as well. We will be more than happy to help you easily obtain the CDSCO license for implantable medical device in India.