What are the 3 types of radiation therapy?

There are three primary types of radiation therapy, also known as radiotherapy, which involve the use of targeted radiation to treat various medical conditions, especially cancer. These types of radiation therapy differ in how they deliver radiation to the target area and the underlying principles of their operation: 1. External Beam Radiation Therapy (EBRT) 2. Brachytherapy 3. Systemic Radiation Therapy (Radioisotope Therapy)

What are 3 types of radiation used in radiation therapy?

Radiation therapy uses high-energy particles or waves, such as x-rays, gamma rays, electron beams, or protons, to destroy or damage cancer cells. Your cells normally grow and divide to form new cells.

What are the requirements for Class III medical devices?

For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for.

A Guide to CDSCO Registration for Radiotherapy Medical Device

Introduction to Radiotherapy Device Category

Radiotherapy devices are essential tools in cancer treatment, utilizing targeted radiation to shrink tumors while minimizing harm to healthy tissues. They include linear accelerators, brachytherapy units, and proton therapy systems. These devices are crucial for curative and palliative cancer care, often integrated with other treatments like surgery and chemotherapy. Advanced imaging and treatment planning technologies ensure precise and safe delivery of radiation therapy.

Read our blog for Medical Device Registration Process for An X-ray Machine.

Looking For Radiotherapy Medical Device Registration Consultation?

Information About an Update on Compulsory Registration for Class C and D Medical Devices

The Central Drugs Standard Control Organization (CDSCO) has introduced changes to the regulatory framework for Class C and Class D (non-notified) medical devices. Instead of mandatory registration, these devices will now adhere to a licensing system outlined in GSR 102(E) dated 11.02.2020. This transition is effective from October 1, 2023.

Manufacturers and importers intending to obtain licenses for these classes of devices must adhere to the Medical Devices Rules (MDR) 2017. They are required to submit applications through CDSCO’s online portal along with the requisite documentation and fees. For detailed information. Please refer to the official circular provided.

List of Class C and D Radiotherapy Medical Devices

Review a couple of Radiotherapy Medical Devices items categorized as Class C and Class D below –

Sr. No.	Device Name	Risk Class
1.	X-ray radiation therapy system	C
2.	Radionuclide radiation therapy system	C
3.	Radiation therapy simulation system	C
4.	Absorbable perirectal spacer	C
5.	Absorbable tissue spacer for radiotherapy	D

Kindly evaluate the entire range of Radiotherapy Medical Devices categorized under Class C and D as presented here.

Need More Clarity on Licensing Regime of Class C and Class D Radiotherapy Medical Devices?

Documents Required for CDSCO Manufacturing License of Class C and Class D Radiotherapy Medical Devices

Obtaining a CDSCO manufacturing license involves a comprehensive dedication to adherence, encompassing precise facility requirements, systematic procedures, and thorough record-keeping. This steadfast strategy ensures the development of medical devices that consistently meet stringent standards for both quality and safety.

Documents Required for CDSCO Import License of Class C and Class D Radiotherapy Medical Devices

Acquiring a CDSCO import license requires obtaining Approval and Free Sale Certificates from well-known international regulatory authorities such as the USA, EU, Japan, Australia, and Canada. These certificates validate adherence to global quality standards and unrestricted market acceptance, underscoring their crucial role in ensuring safety and import excellence.

How Operon Strategist Will Consult You in CDSCO Registration for Radiotherapy Medical Device

Operon Strategist stands ready to provide comprehensive guidance for the CDSCO registration of Class C and Class D radiotherapy medical devices. Our proficiency spans the entire registration process, encompassing the meticulous preparation of required documentation, formulation of applications, and effective liaison with regulatory authorities. Our aim is to facilitate your adherence to the necessary standards and compliance criteria for your devices. Also, we provide consultation for QMS services like ISO 13485 Certification. By teaming up with Operon Strategist, you can streamline the registration journey, reduce time and resource expenditures, and ensure a smooth and successful registration process for your radiotherapy medical devices. get in touch with us today!

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