Singapore Loosens Regulations on Some Low Risk Medical Devices

Starting June 1, Singapore no longer requires certain low risk medical devices, such as sterile medical examination gloves and intravenous sets, to be registered with the government before they are offered for sale.

The change announced by Singapore’s Health Sciences Authority, the regulatory body formed in 2001 to regulate medical products, secure the national blood supply, and provide scientific guidance on forensic science and medicine, is designed to speed to market products previously tested and deemed safe.

The new rule also applies to software and mobile applications intended to function by themselves, such as those that calculate insulin dosage or provide cardiac patients with live monitoring.

Under the new rules, manufacturers will usually be able to bypass the current registration process, which generally takes 60 days, for products which have been approved by two independent regulatory agencies in the United States, Japan, or Australia. If a product has been on the market for three or more years in one of those countries, approval by just one of the agencies will be required.