Singapore’s healthcare services are comparable to those of other industrialized economies. The government spends approximately 3.8% of GDP annually on healthcare.
In 2006, U.S. exports of medical equipment and supplies to Singapore registered a healthy increase of approximately 30% from 2005, with total imports from the United States at US$327 million. This was due to the economic recovery of Singapore and the region. There was also a corresponding increase in total imports though imports from the United States rose more significantly, with the United States capturing a 24% market share. Based on available trade figures for 2007 and market expectations for 2008, U.S. export of medical equipment to Singapore is expected to again register an increase. Overall, regional economies have been steadily improving and thriving, and this is expected to translate into more transshipments through Singapore as the island-state is viewed as a major trade hub and launching pad into the region.
The Singapore Parliament passed the Health Products Act in February 2007 and medical devices was the first health product group to be regulated under the Act. Singapore’s Health Sciences Authority (HSA), through its Centre for Medical Devices Regulation (CMDR), will oversee the system of statutory control aimed to safeguard the quality, safety and efficacy of medical devices available in Singapore. By 2010, all medical devices – from high-risk stents for heart surgery to low-risk ones like mechanical wheelchairs - will need to be licensed. The control measures will keep pace with global trends and standards and the agency will take into consideration the regulatory decisions of benchmark agencies like those of the U.S. Food & Drug Administration, the U.K. Medicines Control Agency, Therapeutic Goods Administration of Australia and the European Agency for the Evaluation of Medicinal Products.
The Singapore government is focused on moving up the value chain through the provision of services that promote research and healthcare delivery in Singapore and the region. Over the next few years, it will pump nearly a billion dollars into the biomedical sciences sector with the aim of boosting health-care standards and clinical research capabilities. The challenge is to develop 'bench to bedside' research that will take R&D into mainstream medicine. The government’s vision is to develop Singapore as the Healthcare Services Hub in Asia and projects that its share of this growing market will expand to 3% by 2012, achieving one million healthcare visitors per year. Singapore is also emphasizing caring for an aging population, living a healthy lifestyle with a focus on preventive care, and doing a better job of tackling chronic illnesses. U.S. firms with revolutionary or cutting-edge medical technology or focus on health screening and disease management would find Singapore an ideal place to launch their products.
The Health Sciences Authority (HSA) is a multidisciplinary agency in health sciences expertise. Its core capabilities encompass administering the national regulatory frameworks for pharmaceuticals, complementary medicines, medical devices and other health products; the running of the national blood bank and provision of transfusion medicine services; and the provision of forensic medicine expertise, investigative forensic and analytical science services.
The HSA’s Center for Medical Device Regulation (CMDR) is entrusted with the responsibility of regulating medical device products placed on the Singapore market. Its objective is to safeguard public health and safety by implementing regulatory controls through a program of pre-market assessment of devices, manufacturing controls and post-market vigilance. CMDR also administers the Contact Lens Practitioners Act through the registration and licensing of Contact Lens Practitioners and the enforcement of the Act and its regulations
Product Certification Process
Since April 1, 2002, the CMDR carries out a range of assessment and monitoring activities to ensure medical equipment available in Singapore are of an acceptable standard under a Voluntary Product Registration scheme. With the passage of the Health Products Act 2007 in February 2007, HSA is implementing the Health Products (Medical Devices) Regulations to better regulate medical devices in
Singapore in three phases:
Phase 1 Implementation Since November 1, 2007, the following duties and obligations were imposed on medical device dealers. Medical device dealers must:
-Report adverse events to HSA within stipulated time frame
-Notify HSA prior to the initiation of a product recall
-Keep records of complaints and product distribution The false or misleading advertisements and promotions of medical devices was prohibited. HSA can direct an advertiser to publish a “corrective advertisement” for any false or misleading advertisements.
Phase 2 Implementation From April 1, 2008, HSA will start accepting applications for licensing of dealers of medical devices and registration of medical device products.
Phase 3 Implementation, the last phase of the implementation will be conducted in 2 stages: From October 1, 2009:
- Unlicensed manufacturing, importation and wholesaling of medical device is prohibited.
- Supply of unregistered Class B, C, and D medical devices is prohibited From October 1, 2010: Supply of unregistered Class A medical devices is prohibited.
By Chia Swee Hoon