Challenges Hover Tab
The medical device industry is familiar with the scrutiny of regulatory organizations, but compliance requirements have increased significantly in recent years. In order to comply to the new regulations, medical device manufacturers are under pressure to significantly upgrade their device traceability practices which involve costs and changes on technology used.
Pharmaceutical manufacturers are at risk to brand reputation damage, material waste, and loss of customers due to product recalls issue which usually caused by mislabeling errors. Logistical costs may increase exponentially depending on how prepared the manufacturer is to deal with the recall.
It is not simply a case of taking money away from licensed manufacturers; falsified medicines may contain active ingredients which are of bad quality or are in the wrong dose – either too high or too low. Without the proper evaluations on their quality, safety and efficacy, such counterfeit drugs could represent a genuine health hazard.
