Medical Devices in China: Regulatory Overview

Medical devices were not required to be formally registered for sale in China until late 1994. Since then, however, several regulations with regard to the import and sale of medical devices have been implemented. The State Drug Administration (SDA) is the central government agency which controls imported medical device (and pharmaceutical) registration and monitoring. Its scope and function is very similar to that of the Food & Drug Administration (FDA) in the United States. The SDA is responsible for ensuring the quality, safety, and efficacy of all imported medical products. All imported medical devices must be registered with the SDA.

In April 2000, a new, more comprehensive and stringent regulatory system for medical devices was introduced. Under the new regime, registration of a new product should (in theory) be completed within 90 business days, though this is still not happening in practice. In addition, the official cost of registration is under US$500, excluding the cost of testing and clinical trials. Real costs can be much higher, especially when the costs of entertainment and “good will” (i.e., Chinese banquets, etc.) are factored in. Registration of Class II and III products generally requires local type tests and clinical testing reports. The SDA can provide lists of certified testing laboratories. All registration documents must be submitted in Chinese, and original or notarized copies are required.

In addition to the SDA, other Chinese government agencies also have jurisdiction over the regulation of certain medical devices. The State Administration for Entry-Exit Inspection and Quarantine (SAIQ) issues safety licenses for imported “consumer products,” which include: medical diagnostic x-ray equipment; dialysis equipment; blood purification equipment; electrocardiographs; implantable pacemakers; and ultrasound equipment. Manufacturers of these products should be prepared to pay over US$10,000 per product to obtain SAIQ approval. The United States government hopes that through ongoing negotiations with regard to China’s WTO accession, the regulation of imported medical devices in China will be further streamlined and rationalized.