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Are there any new or existing requirements that can be referenced for who must be the UDI labeler in situations where one company owns the device design and regulatory path, but allows a customer to use their own branding on the device. The customer then acts as the distributor of their branded product. ...

According to the new medical device regulation in Vietnam, effective Jan 2018, companies shall gain registration approval in order to continue selling or begin selling medical devices. To register the product in Vietnam does the foreign company have to register their legal entity or establish a ...

Thanks you both for your replies, very helpful! ------------------------------ Andrea Curria Regulatory Affairs Specialist Cumberland RI United States ------------------------------

My company has received a request from CFDA for product samples in order to perform post market testing on registered devices. We received registration approval in China following in-country testing to establish compliance to the relevant standards in effect at that time as defined in the Product Standard ...

Thank you all for your feedback. It was very informative and answered all my questions. I had misinterpreted the "may" as the reporting of changes was not a requirement, but I see now that it is. I also learned that this forum is a great place to get answers to questions I may have in the future. Thanks ...