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Testing Standard Requirements around the World

Medical device testing standard- an overview Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country. Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards. Medical device testing applies to all medical devices, in-vitro dia...
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CDSCO Registration Process

This guidance is applicable to manufacturers placed within India. Get detailed information about CDSCO registration process. Regulation Medical Devices Rules, 2017 Important Forms License to manufacturer Notified Medical Devices License in Form MD-5 or 6 for Class A or Class B Application  formForm MD-3 or 4  for Class A or Class BRule 20 Rule 20(4) and 20(6) for Class A or Class B State Drug Licensing Authority License to manufacturer Notified Medical Devices License in Form MD-9...
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