Asian Harmonization Working Party Issues Final Documents on Safety Alert Dissemination System

The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following:

  • To define a structure for disseminating medical device safety alerts among AHWP members;
  • To define roles and responsibilities of regulatory authorities in receiving and disseminating safety alerts; and
  • To define roles and responsibilities of manufacturers or their representatives in case of safety alerts.
  • To avoid an influx of information, AHWP has stated that only events resulting in imminent risk of death, serious injury, or serious illness should be reported.

Medical device manufacturers or their representatives would be responsible for filling out a SADS Form provided on the AHWP website. This form should be completed in English and submitted to the local regulatory authority. The local regulatory authority would then be responsible for disseminating this safety alert to other regulatory authorities via an e-mail system.

Manufacturers/representatives would also be responsible for the following under this SADS:

  • Cooperating with the regulatory authority to conduct investigations on adverse events, performing remedial actions and disseminating safety information;
  • Developing and implementing a procedure for communicating with the regulatory authorities on adverse events and safety information;
  • Maintaining distribution records of products in all AHWP member economies; and
  • Developing an efficient communication channel among all offices in the different AHWP member economies to ensure concerted remedial actions together, if appropriate.

In addition, AHWP is also conducting a survey on the post-market surveillance and vigilance system for AHWP Member Economies. AHWP plans to develop harmonized post-market surveillance and vigilance systems.