The degree to which medical devices are regulated in China is becoming increasingly important. China is implementing a regulatory regime that is opaque and in a state of transition. In the past, an exporter's agents took care of conformity requirements and included those costs in the sales commission. Recently, however, regulations applying to medical devices have been increasing and may become a significant obstacle to exporters. Each body has its own fee structure, which is frequently unpublished.
Some regulators negotiate fees case by case.
Depending on its type, a device may be regulated by any one or all of these bodies. Roughly speaking, SPAC plays the same role in China as FDA in the United States. The Medical Device Administration within SPAC is responsible for registering medical devices. Unlike FDA, however, SPAC has its own manufacturing companies that produce goods that compete with some imports. Although this strikes many in the United States as a conflict of interest, China is a self-proclaimed market economy with socialist characteristics, and the line between public and private is frequently blurred.