China: Draft Regulation Requiring More Clinical Trials for Product Registration on Hold

China is considering requiring more local clinical trials for medical device approval. The Regulation on Supervision and Administration of Medical Devices, passed in 2000 and updated in 2004 and 2007, was largely a reflection of U.S. Food and Drug Administration (FDA) practices. However, as China’s market for medical devices and pharmaceuticals has matured, so have its regulatory structures.

Under current regulations for product registration, Class II foreign-made devices rarely require clinical trials in China. But under the draft proposals — released by China’s State Council in September 2010 — one clause specifies that local clinical trials might be required for the registration of all Class II and Class III medical devices.

Article 18 carves out three exceptions to the proposed rule: 1) The technology is mature, has been used in clinical applications for years with no adverse effects and its general applications remain unchanged; 2) The safety and efficiency of the device can be proven by a non-clinical performance evaluation; and 3) The safety and efficiency of the device can be proven by the analysis of data from similar clinical trials.

Unclear are just how far these exceptions will stretch. In a public comment on the draft, the U.S.-China Business Council expressed concern that the rule’s ambiguity will lead to “increased delays and burdens for SFDA reviews and the possibility of inconsistent implementation.”

As a result, medical device companies looking to register Class II and Class III medical devices in China would be advised to do so before the proposed draft goes into effect.