Clinicians use radiotherapy medical devices to deliver targeted and effective cancer treatments. These specialised devices have a vital role in radiation oncology. Radiotherapy medical devices deliver precise doses of radiation to target tumors. They offer precise and effective cancer treatment, with the aim of minimal damage to surrounding healthy tissues. This blog will walk you through steps of the CDSCO radiotherapy medical devices license application process and its necessary requirements.
Complete guide to obtaining the CDSCO radiotherapy medical devices license
CDSCO medical device license application process is a lengthy and cumbersome process requiring knowledge of the CDSCO guidelines. We have prepared this guide to help you easily navigate the CDSCO medical device license application process.
Documents required for securing CDSCO radiotherapy medical devices license
Several supporting documents have to be prepared for CDSCO medical device license application.
- Organization identity proof
- Sale Deed/Rent Deed of the Premises
- Plant Master File
- Device Master File
- Medical device facility layout
- Documents for the staff who will manufacture and test your medical devices
- ISO 13485 Certificate
- Certificate of analysis of 3 consecutive batches
- Test License, if required for testing the radiotherapy devices
- Environmental regulation compliance documents
We have provided an overview of the documents required for securing CDSCO radiotherapy medical devices license. For the complete list of documents required, feel free to contact us. Additionally, we will help you prepare and compile the documents as per CDSCO guidelines. Our team has extensive expertise in CDSCO medical device license application document preparation. By availing our document preparation service, you can rest easy.
CDSCO radiotherapy medical devices classification
To secure the CDSCO license for radiotherapy medical devices, the first step is to understand the CDSCO medical device classification system. Medical devices are categorised based on potential risks and intended use. They are categorised into four classes, A, B, C, and D, in increasing order of risks. Notably, this classification system has been developed to simplify the license application process. Moreover, different licenses and application processes are required for the different CDSCO classes.
CDSCO radiotherapy medical device classes
We have listed some examples of radiotherapy medical devices belonging to the different CDSCO classes. Most of the radiotherapy medical devices belong to class C followed by class B and D.
Class B
- Brachytherapy system chair
- Compact thermoluminescent dosimetry electrometer
- Laser irradiation therapy kit
- Light beam patient position indicator
- Manual radionuclide applicator system
- Radionuclide brachytherapy table
- Non-powered remote irradiation therapy table
- Non-powered X-rays radiation therapy table
- Operator radiation protection spectacles
- Patient positioning device for whole body diagnostic imaging and radiotherapy
Class C
- Medical charged-particle radiation therapy system
- Absorbable perirectal spacer
- Applicator for bile duct manual brachytherapy
- Applicator for bladder manual brachytherapy
- Applicator for brachytherapy bile duct remote afterloading
- Applicator for brachytherapy Cervical/endometrial remote afterloading
- Applicator for brachytherapy noncentral circulatory general-purpose remote afterloading
- Applicator for bronchial remote afterloading brachytherapy
- Applicator for eye manual brachytherapy
- Applicator for neck manual brachytherapy
- Applicator for prostate manual brachytherapy
- Applicator for tongue manual brachytherapy
- Bile duct brachytherapy system applicator, remoteafterloading
- Brachytherapy needle
- Brachytherapy radionuclide phantom, anthropomorphic
- Brachytherapy system remote afterloading source safe
- Conformal Brachytherapy Source
- Living tissue radiotherapy system
- Medical neutron radiation therapy system
- X-ray radiation therapy system
- X-ray/CT combined linear accelerator system
- X-ray/CT combined particle radiotherapy equipment
- Stereotactic radiotherapy accelerator system
Class D
- Absorbable tissue spacer for radiotherapy
- Blood vessel manual brachytherapy applicator
- Blood vessel remote afterloading brachytherapy applicator
- Brain manual brachytherapy applicator
- Brain remote afterloading brachytherapy applicator
- Breast ductography cannula
- Central circulatory general-purpose manual brachytherapy applicator
- Central circulatory general-purpose remote afterloading brachytherapy applicator
- Central circulatory manual brachytherapy therapeutic radionuclide system
Use our free tool to check which class your radiotherapy medical device belongs to. This will determine your CDSCO radiotherapy medical devices license application process.
Different CDSCO radiotherapy medical devices license types
Different licenses and application processes apply for the different CDSCO classes.
- Manufacturing class A and B radiotherapy devices: You need to apply for MD 5 license. Moreover, a fee of Rs. 5,000 for the manufacturing license will be required. Additionally, Rs. 500 for each distinct device will be required. The license has to be obtained from the state licensing authority.
- Manufacturing class C and D radiotherapy devices: You need to apply for MD 9 license. Moreover, a fee of Rs. 50,000 for the manufacturing license will be required. Additionally, Rs. 1,000 for each distinct device will be required. The license has to be obtained from the central licensing authority.
- Importing radiotherapy devices into India: MD 15 import license has to be secured from the CDSCO to import radiotherapy medical devices into India.
Overview of the CDSCO radiotherapy medical devices license application process
The CDSCO medical device license application process involves the following steps:
- Check CDSCO class: The first step of the CDSCO medical device license application process is to check the CDSCO class. This will determine the license type to be used.
- Document preparation: Compile all necessary supporting documents required for the license application.
- Application submission: File the application online on the official CDSCO online portal. Ensure all details are accurate. Furthermore, properly attach all the documents.
- CDSCO query resolution: CDSCO queries can range from clarification of the submitted documents to requests for additional information. These queries have to be accurately and promptly addressed.
- CDSCO facility inspection: Prepare for the CDSCO medical device facility inspection and audit phase. CDSCO officials may visit the facility to ensure regulatory compliance.
- CDSCO medical device license approval: The regulatory officials will verify all the documents and review the application. Then, if all the criteria are satisfied, the CDSCO will grant the license. This license will permit you to manufacture or import, as applicable, radiotherapy medical devices.
Tips to overcome common CDSCO medical device license application setbacks
Manufacturers and importers might face the following setbacks while applying for their CDSCO medical device license. Hence, we have provided some tips on how to overcome them.
- Incomplete and inconsistent documents: Ensure all documents are up-to-date, meet CDSCO’s guidelines, complete, and consistent in format. Having a checklist handy can be helpful.
- Delays in CDSCO query resolution: Set up a dedicated team to promptly and accurately address CDSCO queries.
- Regulatory non-compliance caught during CDSCO facility inspections: Conduct regular internal audits of the medical device facility to ensure it complies with CDSCO guidelines.
Validity of the CDSCO medical device license
The CDSCO radiotherapy medical devices license will remain valid indefinitely. However, to maintain the validity, the license retention fee has to be paid every 5 years.
How can Pharmadocx Consultants assist you in easily securing the CDSCO medical devices license for radiotherapy devices?
The CDSCO medical device license application process is tricky and cumbersome. Extensive knowledge of the CDSCO guidelines will be required. Furthermore, applying for the license on the CDSCO portal is not an easy task. Additionally, numerous supporting documents will have to be prepared. Moreover, you have to accurately respond to the CDSCO queries. With the support of the Pharmadocx Consultants team, the CDSCO medical device licensing journey will be streamlined and efficient for you. We provide the following comprehensive services to radiotherapy medical device manufacturers and importers to help them in their CDSCO license application journey.
- Assistance throughout the CDSCO medical device license application process.
- Document preparation and compilation as per CDSCO guidelines.
- Conducting pre-inspection audits to ensure readiness.
- Our team will help you promptly address CDSCO queries.
- Comprehensive support from the initial application to license approval.
- We also provide post licensing support. Our team will help you renew your license and ensure ongoing compliance with latest guidelines.
Are you planning to secure the CDSCO radiotherapy medical devices license? Drop an email at [email protected] or call/Whatsapp on 9996859227 to let us help you. Our team will ensure you have a seamless CDSCO medical device license application journey.
