Singapore Launches Standardization for Medical Devices

SPRING Singapore (Standards, Productivity and Innovation Board) and the Economic Development board launched Singapore’s first efforts to standardize the country’s medical devices industry on January 17, 2003. The standard proposed by the governing authorities is called the Technical Reference for Medical Device Components, or TR for short. It is based largely on the US FDA Quality System Regulations (QSR). The TR is currently on a two-year trial and will be open to feedback by the medical device industry before being fully implemented. The Singaporean government hopes their initiative will bring about greater harmonization of quality standards.

The first of the technical references launched this month was the Quality System for Medical Device Components. This interim standard was developed specifically for the biomedical sector in order to cut costs and facilitate Singapore’s scheme to become a biomedical hub. Lee Suan Hiang, Chief Executive of SPRING Singapore, stated, “The Technical Reference is expected to help them [medical device multinationals] save costs, as well as facilitate audit checks on their quality systems. At present, the quality systems used by manufacturers vary and each supplier needs to have its quality system checked by its customers. With a common standard, suppliers can upgrade their capabilities independently, thus reducing the resources required to meet the different requirements of each customer.”

Singapore’s medical device industry generates approximately S$1.6 billion (US$928 million) per year and filled 3,900 jobs in 2001.