The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.
As the saying goes, if it looks too good to be true, it probably is.
A more comprehensive management approach is needed to tackle the rising threat of diabetes in the region.
The document clarifies the MDR regulation and reporting requirements for medical device companies.
Failure to provide records during an inspection will undoubtedly lead to a warning letter.