Singapore Updates Industry on Medical Device Regulations

Under Phase 1 of Singapore’s medical devices regulation — activation of duties and obligations of dealers and advertising and promotion controls — firms are required to keep distribution and complaint records, according to a recent Health Sciences Authority (HSA) briefing for industry.

Phase 1, which took effect in October, provides for mandatory recalls, product testing and submission of documents upon HSA request, as well as advertisement and promotion controls. It also mandates reporting adverse events and product recalls to the manufacturer and HSA. Previously, the requirements were voluntary.

The regulation, which was passed by Parliament Feb. 12, will be launched in three phases over the next three years, HSA said. Under Phase 2, which takes effect April 1, 2008, licensing requirements for all establishments dealing in medical devices and medical device registration applications will be implemented.

Phase 3, set to take effect Oct. 1, 2009, covers bans on unlicensed parties dealing with medical devices, prohibitions on unregistered medium- and high-risk devices and supply of unregistered low-risk devices.

According to HSA, manufacturers must be certified to ISO 13485 or equivalent. Importers and wholesalers must be certified to good distribution practice for medical devices in Singapore, the agency said, adding that certification must be obtained through certification bodies accredited by the Singapore Accreditation Council.