The main source of these goods was China, which supplied about 28 per cent of these products. The second most important source was the European Union, with 18% of total imports. Given that medical devices are a much more heterogeneous group of products than drugs, it is understandable that there is some variation in clinical assessments. In fact, a recent GAO report revealed that approximately 90 per cent of the medical devices reviewed by the FDA were marketed through 510(k) review, while 10 per cent underwent the full pre-market approval process (5).
A medical device can be any instrument, apparatus, appliance, implement, machine, apparatus, implant, in vitro reagent, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for a medical purpose. In the context of a sound healthcare system, they ensure access to safe, effective and high quality medical devices that prevent, diagnose and treat diseases and injuries, and assist patients in their rehabilitation. The legal provision indicates that this decision should be based on whether a device is considered "reasonable and necessary", which has been translated as "accepted by the medical community as a safe and effective treatment for a particular condition". The Organisation also works with member states and collaborating centres to develop guidelines and tools, including norms and standards on medical devices.
In addition, as President Scholl noted, the liberalisation of medical supplies through the "zero-for-zero" pharmaceutical initiative and the development of a crisis response committee at the WTO would also have a significant impact. Health Canada's Medical Devices Bureau recognises four classes of medical devices based on the level of control required to ensure the safety and efficacy of the device. Currently, there are an estimated 2 million different types of medical devices on the global market, classified into more than 7000 generic device groups. International and national standards can also have an important influence on the manufacturing process, for example those established by the Association for the Advancement of Medical Instrumentation or the International Electrotechnical Commission (11).
Medical devices benefit patients by helping healthcare professionals to diagnose and treat patients and to overcome diseases, improving their quality of life. An example of high-risk devices are those with embedded software, such as pacemakers, that assist in medical tests, implants and prostheses. This publication was developed in response to the need for a reference list of priority medical devices required for the management of non-communicable diseases. Employed primarily by hospitals, BMETs are the individuals responsible for maintaining a facility's medical equipment.
Komen recently wrote to President Trump to insist that government policies "must not restrict access to or destabilise the supply chain of currently available pharmaceuticals or medical devices".