Medical Diagnostics A class of medical instruments known as "X-ray equipment" is utilized to create and record images of the interior of the body for diagnostic reasons. These devices provide finely detailed images of bones, tissues, and organs using X-rays, a type of electromagnetic energy.
medical diagnostics X-ray technology is essential to contemporary healthcare since it allows for precise diagnosis and therapy planning. Imaging techniques have improved with time, becoming safer, more effective, and more exact, which is good news for patients and healthcare professionals alike.
The necessity for early and precise diagnosis, the growth of healthcare services, the rising prevalence of diseases, technological advancements, and more all contribute to the ongoing high demand for diagnostic medical x-ray equipment. It will continue to be a pillar of healthcare for many years to come thanks to its ongoing development and integration with other medical technology.
Under IS standard IS 7620 (Part-1): 1986, all diagnostic medical x-ray equipment is now covered by the required ISI Certification Scheme.
Without the ISI Mark, this product cannot be marketed, imported, or exported into the Indian consumer market.
Indian Standards Institute, or ISI was renamed the Bureau of Indian Standards (BIS) in 1987. The official mark that the Bureau of Indian Standards provides for manufacturers of various goods is the ISI Mark. It is used to indicate compliance with Indian standards (IS) set by the Bureau of Indian Standards (BIS) and has been used as a conformity marking for industrial products. Manufacturers received permission from BIS to use the ISI Mark on items that comply with relevant Indian requirements through the product certification program.
Only manufacturers (domestic or foreign) who produce the finished product will be awarded ISI Certification. This will not be given to any product importers, traders, dealers, or distributors.
The following documentation is required to get an ISI certification:
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There are two approaches for Indian manufacturers to become certified with the ISI Mark:
Regular Procedure
With the possible exception of cases deemed "All India first," which might take up to 180 days, the licensing procedure is expected to be finished in 120 days. This timeline starts on the day the application is received, assuming that at different points in time the documentation, unit assessment, and product conformance are all deemed acceptable.
Step 1: Manufacturing Unit Customization in Compliance with Applicable Indian Standards
Step 2: Submission of the Application Form
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Simplified Procedure
This is a much faster process than the standard procedure. After a factory inspection is deemed satisfactory and the initial evaluation establishes that the sample complies with the applicable Indian Standard(s), the license application process is expected to be finished in 30 days.
Step 1: Adapting the Manufacturing Unit to Comply with the Relevant Indian Standard
Step 2: Sample Testing
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The process of obtaining ISI Mark Certification for Foreign Manufacturers typically includes the following steps:
Step 1: Application
Step 2: Query Raised (If Any)
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Brand Liaison provides helpful support for achieving ISI Mark Certification. Among our offerings are:
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