Singapore to regulate market for medical device
Singapore said on Wednesday it will regulate the growing and increasingly sophisticated market for medical devices to ensure that they comply with global standards.
The Health and Sciences Authority (HSA) said it is developing a regulatory framework in accordance with global harmonisation efforts and has established a Centre for Medical Device Regulation (CMDR).
"When implemented, the regulation will require all diagnostic medical equipment, surgical implants and other medical therapy equipment to be approved and licenced by HSA through its CMDR," a statement from the HSA said.
It said that regulation was necessary "to safeguard the health of patients and users" and to "ensure that patients have timely access to the state-of-the-art, life-saving equipment that are effective."
Affluent Singapore is fast becoming a user of advanced scientific technology and increasingly sophisticated medical devices. But currently, there is no statutory requirement for the licencing of medical devices. Only contact lenses and care products, radiation emitting devices and condoms come under regulation.
The HSA will introduce an online database to facilitate the registration of medical devices marketed in Singapore as well as a scheme where complaints of adverse effects are handled and followed up.
"In a world where science, medicine and technology combine to create ever more important tools, solutions and remedies, the role of safeguarding public health and well-being... is more critical than ever," said minister of state for health and environment Balaji Sadasivan.