Medical Device Conformity Assessment for ASEAN Countries

The Medical Device Product Working Group of the ASEAN Consultative Committee for Standards and Quality (ACCSQ-MDPWG) held a meeting from July 30 to August 2, 2007. In this meeting, the ASEAN (Association of Southeast Asian Nations) countries discussed proposals for conformity assessment on medical devices.

Singapore’s Health Sciences Authority (HSA) prepared papers and presentations to facilitate discussions on this issue and help the ASEAN countries reach consensus on adopting a harmonized conformity assessment system.

This conformity assessment would be applicable to all medical devices, including in-vitro diagnostic test kits. The HSA presented multiple options for conformity assessment systems, including having independent, government approved conformity assessment bodies (CABs) evaluate and ensure compliance or entrusting this process to governmental regulatory bodies.

The HSA also presented the types of items typically included in a conformity assessment system, such as quality management system compliance, adequate proof of device safety and performance, and a declaration of conformity stating the manufacturer, product name, applicable standards, party responsible for the product, etc.

During the meeting, various parties discussed how the conformity assessment system should be implemented. Based on the meeting, the following principles would be included in the conformity assessment system:

  1. essential requirements on safety and efficacy, where manufacturers will decide which standards to use to demonstrate compliance to these essential requirements;
  2. conformity assessment through third party CABs selected and designated based on certain criteria and requirements;
  3. and possible clinical data requirements for Class III and IV medical devices.

Going forward, the MDPWG will further review these items and proposals to determine an appropriate harmonized ASEAN conformity assessment system.