Register Urology Devices With CDSCO
Urology deals with male and female urinary tract diseases, with a focus on the male reproductive organs. Urology focuses on the kidneys, ureters, urethra, urinary bladder, and adrenal glands, as well as the male reproductive organs (testes, epididymis, vas deferens, prostate, penis, and seminal vesicles). Urology diagnostic and therapeutic procedures must be precise and qualitative, so this field requires durable and advanced medical equipment. Urology devices include kidney stone punches, ureteral stents, fiber Uteroscopes, urodynamic system, and many other devices.
Urology performs a variety of procedures, including laser surgeries, minimally invasive robotic and laparoscopic surgeries and other scope-guided procedures. When diagnosing and screening for urological disorders, medical professionals use a variety of various tools and tests. This necessitates the consideration of diagnostic instruments, which calls for a certain level of complexity and depth. Depending on the organ and area affected, urological diseases can be treated with a number of urological medical devices. As a turnkey project consultant, we provide best solutions as per the project needs to urological medical device manufacturers. Urology devices need to be safe and effective because patients or end users are subjected to a variety of health and safety risks. The risk increased along with the growth of the medical device sector. For the safety of the devices and to reduce the risk of the devices CDSCO mandated the registration of these urological devices before manufacturing /importing to India.
CDSCO Regulations for Urological Medical Devices:
According to recent CDSCO updates, it is now mandatory to register your Class A and Class B devices, and for the registration of Class C and Class D devices CDSCO will update the things soon. The CDSCO registration process requires risked based classification of the devices. Click here to check the updated list of classification. Manufacturers require technical files of documentation, such as application forms, ISO13485 certificates, plan master files, etc. for CDSCO registration.
Key Points for Acquiring CDSCO Registration:
- First check whether the device is notified or non-notified devices category. Urology devices are notified devices and calls for the mandatory registration. As CDSCO registration consultant, we provide end to end assistance to urology device manufacturers in the licensure process.
- If you are foreign manufacturer, you need to appoint IAA (Indian Authorized agent) who will take care the responsibilities on your behalf.
- The IAA must complete all responsibilities and submission to the respective authority to obtain CDSCO registration for urological medical devices.
Urology Devices Market:
It is anticipated that the market for urology devices would see increased sales due to the growing desire for minimally invasive procedures brought on by recent technological advancements. Due to the increasing prevalence of urologic disorders, medical device manufacturers are increasing their production capacity in order to produce effective and safe urological devices. Our team assist them in manufacturing plant layout designing so that they produce safe and effective devices for the patients. Manufacturers are developing high-quality urology devices for the diagnosis and treatment of urological disorders. Thus, an increase in the number of patients suffering from urology disorders such as urological cancer, kidney blockages, prostate cancer, and so on is driving demand for urology devices such as urology catheters, stents, urology guidewires, drainage bags, and so on.
How we Help Urology Devices Manufacturers in Obtaining the License?
We are leading medical device regulatory consultant and assisting device manufacturers for more than 15 years, we know the modus operandi for audits and regulatory strategies and hence we guide and train medical device manufacturers as per the requirements. Our work flow is clear and transparent so that the manufacturers can obtain the license easily. We provide assistance for CE mark, FDA 510(k) Clearnce, CDSCO registration and manufacturing license, ISO13485 QMS set up and training, 21CFR part 820 QMS implementation, DHf preparation and so on.
Any medical device manufacturer who wants to design and develop the medical device can approach us for the entire device design process. As a medical device regulatory consultant, it’s our responsibility to provide correct and trustworthy guidelines to all device makers, and we are happy that we have achieved so much so successfully.
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