Asian Harmonization Working Party Proposes Post-Marketing System

The Asian Harmonization Working Party (AHWP) has recently drafted a post-marketing system to harmonize medical device adverse event reporting. AHWP members have varied systems for adverse event reporting, and some have no system at all. The new draft document aims at reducing delays in corrective action, decreasing exposure to faulty devices, and lowering remedial costs when medical devices fail.

AHWP appointed Singapore to propose an adverse event reporting framework. Singapore presented two options. One was a “central clearing-house” approach where all information is gathered and disseminated by a central body. AHWP rejected this option due to logistical issues and large estimated costs for setup and maintenance.

The other option, which AHWP settled on, is called a “nodal distribution system.” This system would not involve a centralized organization. Instead, medical device manufacturers would report certain adverse events to all regulatory authorities for where the product is registered.

After each country’s regulatory authority has been notified of the adverse event, they would have the option of deciding whether or not to recall the affected medical device. In some cases, a regulatory authority may decide that the safety alert does not apply to its domestic users. As mentioned previously, AHWP does not plan to have a centralized body managing and communicating adverse events. Instead, each regulatory authority will have independent jurisdiction over the information.

The exact definition of a reportable adverse event is still in discussion. Currently, AHWP has proposed focusing on adverse events requiring corrective actions in the domestic country. AHWP is also working on what information should be reported and the deadlines required for this reporting. The group is also working out a harmonized set of adverse event reporting exemption rules.

AHWP member countries include China, Hong Kong, Indonesia, Malaysia, the Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam.

This plan, if approved, would not replace or remove current regulations on adverse event reporting in each of the member countries.