Trans-Pacific Partnership to Improve Medical Device Regulatory Coherence

On November 12, 2011, the United States and eight other countries jointly announced the outline for a new Trans-Pacific Partnership (TPP) on trade and investment. This landmark partnership aims to coordinate economic activity, regulatory standards, and tariffs in all trade areas. In particular, a chapter on aligning regulatory principles for medical devices has been proposed, and is currently under discussion.

According to experts, the TPP chapter on medical devices will include key provisions that lead to greater regulatory coherence across countries. Discussions on the chapter are still at an early stage, and exact outcomes cannot yet be predicted. If successful, it will provide guiding regulatory principles to which participating countries should adhere. It will not prescribe specific requirements on each country’s regulatory regime.

The TPP’s current formal participants are: Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, Vietnam, and the United States. Japan also announced its decision on November 11 to join talks on TPP participation. As of mid-December, Japan is preparing a multi-ministerial delegation to begin consultations with other TPP members. Advocates also urge for the inclusion of China, who has neither actively sought to participate nor been asked to join.