ISO, EU MDD and USFDA the definition of Medical device varies slightly. In short, a product can be called as a Medical Device if it is used for treatment, in diagnosis, therapy or in surgery. Manufacturing and sales of medical devices are highly controlled because of the complexities of the medical devices indented application. Country wise specific regulatory requirements are applicable for all medical devices.
To export a medical device from one country to another, the importing countries regulatory requirements have to be met before exporting. Our service starts here!!!
- USA - FDA approval
- Europe - MDD
- Canada - Health Canada registration
- Japan - PAL approval
- China - SFDA approval
- Korea - KFDA approval
- India - CDSCO approval
Kindly look into various country specific requirements in detail throughout our website. Our one-stop shop approach offers a wide range of services designed to help export of medical devices to global markets fast
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