New Taiwan medical device regulations still stalled

Two years after Taiwan’s Food and Drug Administration first proposed establishing dedicated regulations on medical devices, efforts to separate oversight of the growing industry from that of pharmaceuticals remain stalled. Since 1973, when Taiwan established the Pharmaceutical Affairs Act, regulations of medical devices have been subsumed under that law, which is chiefly designed to apply to the drug industry.

Among the principal limitations of the Pharmaceutical Affairs Act is that it pegs responsibility for regulatory compliance to the factory where a medical device is produced, rather than to the company which designs and markets a particular product. That practice is at odds with medical device regulations in the United States, the European Union and other modern economies, and makes it cumbersome for device manufacturers to add or drop product lines to reflect new developments in technologies and markets.