Governmental regulation of medical devices

Although different authorities have different systems of premarket review, they all apply a similar risk-management philosophy in which all medical devices must satisfy safety and performance, quality system, and labeling requirements. The degree of regulatory scrutiny increases with the potential risks of the medical device, as evidenced by the risk-based device classification system proposed by the GHTF. 

Governments around the world approve the sale of medical devices in many different ways. In Australia the Therapeutic Goods Administration issues an Australian Register of Therapeutic Goods number to devices cleared for the market. In Canada a device licence is awarded by the Therapeutic Products Directorate. In the European Union, after receiving an EC certificate from a notified body, the manufacturer places the CE mark on the device. In Japan a shounin is issued by the Pharmaceutical and Medical Safety Bureau of the Ministry of Health, Labor and Welfare. In the United States the manufacturer of the device receives a marketing clearance (510(k)) or an approval letter (PM A) from the FDA. 

In the United States, most Class III and new devices that are not substantially equivalent to a legally marketed product that does not need a PM A application require clearance through the PMA or Product Development Protocol processes. Most Class II and some Class I devices require a premarket entry notification known as the 510(k), which is essentially an information package for the FDA that receives less stringent review than the PMA process. The 510(k) submission must demonstrate how the proposed medical device is substantially equivalent to a medical device that is already on the US market. Most Class I and some Class II (low-risk) devices are exempt from 510(k) submission before sale, but are stiU subject to general control requirements. 

Vendor information facilitates governments in tracking medical device vendors. In Australia the sponsor must hold an enterprise identification number before being permitted to apply to register or list products. Similarly, in Canada any individual or company wishing to sell medical devices must apply for permission to obtain an establishment licence. The European Union requires a responsible person of the vendor establishment with a physical address in Europe be registered. In Japan, medical device 

In postmarket snrveillance stndies, specific and structured data collections are required of the manufacturer in one of two situations as a condition of product approval, or to reaffirm product safety when postmarket adverse event reports suggest that pre-market safety claims are inconsistent with actual use and result in unacceptable risk. 

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