The medical device landscape in India is stringently regulated, with the Central Drugs Standard Control Organization (CDSCO) at the helm. CDSCO ensures that medical devices, especially those as critical as oncology devices, meet stringent standards to guarantee patient safety. In this blog, we will focus on CDSCO oncology medical devices registration and license application process. We have detailed the CDSCO medical device classification system for oncology devices. Furthermore, we have provided an overview of the documents required and the CDSCO license application process. Additionally, we have provided some tips for you to have a smooth CDSCO license application process.

CDSCO Oncology Medical Devices Registration and License Application Process

CDSCO Medical Device Classification

Before diving into the specifics of oncology devices, it’s crucial to grasp the classification of medical devices under CDSCO’s purview. Medical devices are categorized from Class A to Class D based on their associated risks, with Class A being the lowest risk and Class D being the highest.

Oncology medical devices have pivotal roles in diagnosing, monitoring, and treating cancer, thereby making their regulation paramount. Oncology medical devices are primarily integral to life-saving procedures or treatments. Hence, they mainly belong to moderate-high to high-risk categories (Class C and Class D devices). For the CDSCO oncology medical devices registration and license application process, understanding the medical device classification system is important. While applying for the CDSCO license, you need to know which CDSCO class your medical device belongs to. 

CDSCO oncology medical device classes

We have listed few examples of oncology medical devices belonging to the four CDSCO classes.

Class A

• Antimicrobial postsurgical brassiere
• Antimicrobial postsurgical female underpants
• Brachytherapy radionuclide phantom, test object
• Breast binder
• Breast transilluminator

Class B

• Bladder instillation buffer solution
• Colonic cytology sampling set
• Acupressure wristband
• Flexible ultrasound bronchoscope

Class C

• FerriScan R2-MRIAnalysis System
• Alternating electric field antimitotic cancer treatment system generator
• Alternating electric field antimitotic cancer treatment system transducer array
• Breast 3-D infrared imaging/vascular analysis system
• Cryosurgical set
• Capsular tension ring
• Electro cancer therapy system
• Electronic clinical breast examination system
• Endocervical aspirator
• Balloon kyphoplasty kit
• Accelerator system chair
• Accelerator system quality assurance device
• Anorectal brachytherapy system applicator, manual
• Anorectal brachytherapy system applicator, remote-afterloading

Class D

• Alternating electric field antimitotic cancer treatment system
• Coronary artery brachytherapy system applicator, manualafterloading

Documents Required for CDSCO Oncology Medical Devices Registration

We have provided an overview of the documents required for securing the CDSCO oncology medical device license.

1. Sale Deed/Rent Deed of the Premises
2. Organization identity proof
3. Plant Master File
4. Building Layout with Dimension
5. Device Master File
6. Test License, if required for testing the oncology medical device
7. Environmental regulation compliance documents
8. Certificate of analysis of 3 consecutive batches
9. ISO 13485 Certificate
10. Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.

New CDSCO Guidelines for Oncology Medical Devices Registration

With the evolving medical landscape and technological advancements, CDSCO continually refines its guidelines to stay abreast. Thus, oncology medical device manufacturers and importers must be aware of the latest CDSCO guidelines. These guidelines detail the registration process, documentation requirements, and quality standards that oncology devices must meet.

Notably, for Class C and Class D oncology devices, rigorous device testing has been given special emphasis. Additionally, quality checks have to be performed before the devices reach healthcare professionals and patients.

The Deadline for Oncology Medical Devices Registration and Licensing: Key Dates to Remember

CDSCO has recently revamped its guidelines for Class C and Class D medical devices that aren’t notified. Instead of the earlier mandatory registration process, these devices will now fall under a licensing structure. This has been mentioned in the GSR 102(E) document dated 11.02.2020. This change is set to kick in from October 1, 2023. If you’re a manufacturer or importer seeking the CDSCO license, it’s essential to follow the Medical Devices Rules, 2017. Moreover, all applications, along with the needed paperwork and fees, should be sent through CDSCO’s online system. Furthermore, for a clearer picture and more specifics, it’s a good idea to refer to the official CDSCO circular.

CDSCO Oncology Medical Devices Registration: Licensing and Requirements

• Class A and Class B oncology medical devices: MD 5 License is required. A fee of Rs. 5,000 for the manufacturing license and Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
• Class C and D oncology medical devices: MD 9 License is required.A fee of Rs. 50,000 for the manufacturing license and Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.
• Importing oncology medical devices into India: MD 15 Import License has to be secured from the CDSCO to import oncology medical devices into India.

CDSCO Oncology Medical Devices Registration and License Application Process Overview

Navigating the CDSCO registration process can seem daunting, but with a clear roadmap, it becomes manageable. We have provided a step-by-step breakdown of the CDSCO oncology medical devices registration and license application process.

1. Document preparation: All necessary documents, including clinical trial data, quality certifications, and product specifications, have to be prepared. Additionally, the documents have to be compiled and arranged per CDSCO requirements.
2. Application Submission: File the application online, ensuring all details are accurate. Additionally, all required documents have to be attached.
3. Query Resolution: Address any queries raised by CDSCO promptly. This can range from clarifications on the submitted data to requests for additional information.
4. Inspection: Prepare for and cooperate during the inspection phase, where CDSCO officials may visit manufacturing facilities to ensure compliance with guidelines.
5. License Approval: Once all criteria are met, CDSCO will grant the license. This license will permit legal manufacturing or import of the oncology medical devices.

Common CDSCO Medical Device License Application Challenges and How to Overcome Them

The CDSCO oncology medical devices registration process can present some challenges. Hence, we have provided some tips on how to overcome them.

• Documentation Gaps: Ensure all documents are up-to-date and meet CDSCO’s requirements.
• Delays in Query Resolution: Allocate a dedicated team to address CDSCO queries promptly.
• Inspection and Audit Hurdles: Regularly audit manufacturing facilities to ensure they meet CDSCO standards.

By anticipating these challenges and having mitigation strategies in place, manufacturers can ensure a smooth oncology medical devices registration process.

How Can Pharmadocx Consultants Assist in Navigating the CDSCO Oncology Medical Device License Application Process?

Navigating the intricate maze of CDSCO oncology medical device license application process requires expertise. This is where the Pharmadocx Consultants team of experts comes into picture. With a rich expertise in the CDSCO regulations and a history of assisting manufacturers and importers, we offer the following:

Securing the CDSCO license for oncology medical devices is more than just a regulatory requirement. It is a commitment to delivering quality medical devices that healthcare professionals can trust and patients can rely on. With Pharmadocx Consultants by your side, the CDSCO registration process becomes less daunting as well as smooth and efficient.

Ready to navigate the CDSCO oncology medical devices registration with ease? Drop an email at [email protected] or call/Whatsapp on 9996859227 today for unparalleled expertise and guidance!