With increase in prevalence of cancer in India, the demand for oncology medical devices is increasing. To manufacture or import oncology medical devices, you need to secure the CDSCO medical device license. We have curated this guide to help you secure the CDSCO oncology medical devices license in a hassle-free manner.
What are oncology medical devices?
Oncology medical devices are specialised instruments and devices used for the diagnosis, treatment, and management of cancer. These devices play a crucial role in various stages of cancer care. They are used to screen, diagnose, treat, manage, and monitor progress. The 5 key categories of devices are as follows:
- Diagnostic devices
- Surgical devices
- Radiotherapy equipment
- Systemic therapy devices
- Palliative care device
CDSCO regulations for oncology medical devices
The CDSCO aims to ensure high-quality, safe, and effective oncology medical devices are available in the Indian medical device market. By preventing the entry of substandard medical devices in the Indian market, CDSCO aims to fulfil its vision of making India a global medical device hub. Hence, medical device manufacturers and importers are required to abide by the CDSCO regulatory guidelines. Furthermore, the medical device manufacturing process should be at par with the standards set by CDSCO to ensure the finished products meet international quality benchmarks. To manufacture oncology medical devices in India, you have to secure the CDSCO medical device manufacturing license. In contrast, to import oncology medical devices into India, you have to secure the CDSCO medical device import license. Moreover, to secure these licenses, you have to comply with the CDSCO regulatory guidelines.
CDSCO oncology medical devices classification system
CDSCO has classified medical devices into four classes. The CDSCO medical device classification system is based on the risk level associated with the intended use of the medical device. The classes in increasing order of risk level are A, B, C, and D. This classification system has been developed to ease out the medical device license application process. Moreover, specific licenses are applicable for specific CDSCO medical device classes.
Class A
- Capsular tension ring
- Blepharoplasty scissors
- Brachytherapy radionuclide phantom, anthropomorphic
- Antimicrobial postsurgical female underpants
- Antimicrobial postsurgical brassiere
- Extravascular-circulation hyperthermia system applicator, extracorporeal
- Eye brachytherapy system applicator, manual
- Cytotoxic waste receptacle
- Cervical cytology scraper, reusable
- Breast binder
Class B
- Bladder instillation buffer solution
- Acupressure wristband
- Externally-propelled flexible video colonoscope
- Facial prosthesis
- Flexible fibreoptic bronchoscope
- Flexible fibreoptic colonoscope
- Class-I biological safety cabinet
- Brachytherapy system chair
- Brachytherapy system remote afterloading source transfer tube
Class C
- Activated-oxygen generator
- Alternating electric field antimitotic cancer treatment system generator
- Alternating electric field antimitotic cancer treatment system transducer array
- Brachytherapy needle
- Breast 3-D infrared imaging/vascular analysis system
- Cancer risk assessment interpretive software
- Endocervical aspirator
- Electronic clinical breast examination system
- Accelerator system operator console
- Bile duct brachytherapy system applicator, remote-afterloading
- Flexible fibreoptic mediastinoscope
- Class-II biological safety cabinet
- Cervical cone knife
- Brachytherapy system remote afterloading source safe
- Brachytherapy system remote afterloading operator console
- Electro cancer therapy system
Class D
- Alternating electric field antimitotic cancer treatment system
- Extravascular-circulation hyperthermia system
- Extravascular-circulation hyperthermia system applicator, intracorporeal
- Flexible ultrasound bronchoscope
- Coronary artery brachytherapy system applicator, manualafterloading
- Breast transilluminator
- Brain brachytherapy system applicator, manual
- Brain brachytherapy system applicator, remote-afterloading
To check which class your medical device belongs to, you can use our free tool.
CDSCO oncology medical devices license types
- Importing oncology medical devices into India: MD 15 import license has to be secured from the CDSCO to import oncology medical equipment into India.
- Manufacturing class A and B oncology medical devices: MD 5 license will be required to manufacture class A and B oncology devices in India. A fee of Rs. 5,000 for the manufacturing license is required. Furthermore, Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
- Manufacturing class C and D oncology medical devices: MD 9 license will be required to manufacture class C and D oncology devices in India. Moreover, a fee of Rs. 50,000 for the manufacturing license is required. Additionally, Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.
CDSCO oncology medical devices license validity
The CDSCO oncology medical devices license remains indefinitely. However, the license retention fee has to be paid every 5 years to maintain the license validity.
What are the documents required for securing the CDSCO license for oncology medical devices?
We have listed the documents required to apply for the CDSCO oncology medical devices license.
- Sale Deed/Rent Deed of the Premises
- Organization identity proof
- Building layout
- Device Master File
- Plant Master File
- ISO 13485 Certificate
- Test License, if required for testing the oncology medical device
- Environmental regulation compliance documents
- Certificate of analysis of 3 consecutive batches
- Documents for the team of qualified and experienced staff who will manufacture and test the devices.
Each document has a crucial role in demonstrating regulatory compliance. Hence, they have to be prepared carefully. We have provided an overview of the documents required. For a detailed list of documents, feel free to contact us. Furthermore, we have extensive expertise in CDSCO document preparation. Our team of experts will help you prepare and compile the documents as per CDSCO guidelines.
How to apply for the CDSCO oncology medical devices license?
We have provided an overview of the CDSCO license application process.
- Check CDSCO class: The first step while applying for CDSCO medical device license is to check which class your medical device belongs to. The application process will proceed accordingly.
- Document preparation: Compile all necessary documents. All supporting documents have to be meticulously prepared, as they are used to demonstrate the device meets stringent quality and safety requirements.
- Application submission: File the application online on CDSCO’s official online portal. Additionally, upload all the necessary documents along with the application.
- CDSCO query resolution: CDSCO may raise queries that have to be promptly and accurately addressed.
- Medical device facility inspection: Prepare for the CDSCO medical device facility inspection and audit phase. The regulatory officials may visit the medical device facility to carryout inspection for evaluating regulatory compliance.
- License grant: Once all the criteria are satisfied, CDSCO will grant the applicable medical device license.
How to overcome common challenges faced during CDSCO license application?
Manufacturers and importers might face some challenges while applying for their CDSCO license. Hence, we have provided some tips on how to overcome them.
- Ensuring all documents are complete, consistent, up-to-date, and meet CDSCO’s requirements.
- The CDSCO queries have to be promptly and accurately responded to. Hence, setting up a dedicated team will help promptly address CDSCO queries.
- Regularly conduct internal reviews of the facility to identify any non-compliance and correct them.
How will Pharmadocx Consultants assist you in securing the CDSCO license?
We offer comprehensive services to support medical device manufacturers and importers. Our team is committed to ensure our clients have a regulatory journey free from any hiccups.
- Expert Guidance: Assistance throughout the CDSCO medical device license application process.
- Documentation Support: We provide comprehensive document preparation support for CDSCO license application.
- Mock Audits: We conduct mock audits to identify lapses. Additionally, we provide actionable next steps to correct the lapses.
- Query Resolution: Our team will help you promptly address the queries raised by CDSCO.
- End-to-End Support: We provide comprehensive support from the initial application to license approval. We will provide support till you successfully secure the CDSCO medical device license. Furthermore, we provide post-license application support for ongoing compliance and license renewal.
Securing the CDSCO medical device license is a mandatory requirement for which compliance with CDSCO guidelines is non-negotiable. Mandatory CDSCO medical device license requirement ensures that healthcare professionals are equipped with the best tools for patient care. Moreover, compliance with CDSCO regulatory guidelines is a testament of the manufacturer’s dedication to patient safety and product quality. Furthermore, staying compliant ensures trust in the brand and helps avoid potential regulatory negative repercussions. Are you planning to apply for CDSCO oncology medical devices license? Email at [email protected] or call/Whatsapp on 9996859227 for a smooth CDSCO regulatory journey.
