Tag Archive for: expedited review

Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.

Expedited Market Access Now Available in Philippines

On September 27th 2022, the Philippines FDA published Circular No. 2022-008 announcing that Class B, C, and D medical devices that have been already approved by a member country of the Association of Southeast Asian Nations (ASEAN) will be eligible for the Reliance registration route, allowing for a quicker review and expedited market access.