International Collaboration on Medical Device Regulation: Issues, Problems and Stakeholders
Commercialization of health care around the globe manifests itself in the liberalization of markets and global trade and health care reform measures, including competition and privatization, generating a shift in the balance of power away from the stewardship of the state to free markets. These transformations are especially important for medical devices which carry special risks when unregulated or inappropriately regulated. They may be wrongly classified, dumped on foreign markets where regulatory requirements may be lower, or can even be fraudulent products. The key issue for public health is whether recent trade in medical products, as well as the global and regional harmonization of product and diagnostic standards, have encouraged a widening gap between patients and providers. Conversely, has commercialization produced some tangible (if indirect) benefits to some patient groups and providers?
KeywordsMedical Device International Collaboration Intellectual Property Right Trip Agreement National Electrical Manufacturer Association
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