February 25, 2014
Singapore, a small island nation in the South China Sea with a population of 5.5 million, has recently become a hot spot for sophisticated pharmaceutical research and manufacturing. In 2013, the country had an average purchasing power parity (PPP) per-capita GDP of over $61,000, about $10,000 more than in the U.S.
February 3, 2014
The ten nations that make up the Association of Southeast Asian Nations (ASEAN) -- Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam -- together have a population of over 610 million, almost twice the population of the U.S. The ASEAN countries' combined GDP is more than $2.28 trillion, or about 25% the GDP of China. The region had a 2013 GDP growth of around 5.9%, compared with an estimated 2.5% GDP growth in the U.S. and .01% growth in the EU.
February 19, 2013
The tiny island nation of Singapore is very rich, with an average per capita income of $60,000 in 2012. With a 2011 GDP of $260 billion, the Singaporean economy is bigger than that of Portugal, Israel and Ireland -- even with a much smaller population than any of those countries. Healthcare expenditure in Singapore was approximately $11.7 billion in 2012, and it is expected to reach $22.3 billion by 2018. High levels of wealth and healthcare expenditure make Singapore's medical device market very attractive.
February 5, 2013
The medical device market in Singapore reached $535 million last year, despite its small land area and a population of only 4.7 million. Singaporeans' strong demand for better healthcare creates an excellent market for foreign medical device companies, who supply more than 85 percent of the country's devices. Leading importers include the US, Germany and Japan. As long as foreign companies understand key requirements, medical device registration in Singapore is not difficult. Several rules to ease market access were enacted in 2012, and more are expected for the rest of 2013. Companies that keep up with the new rules should find registration both quicker and less expensive.
Pacific Bridge Medical presents Singapore Medical Device Regulatory Updates, a 2011 webcast/webinar on changes in Singapore's regulatory system for medical devices.
October 1, 2010
Before Singapore's Health Products Act 2007, most medical devices did not fall under governmental regulations. From August 1, 2010 onwards, all of these medical devices need to be re-registered under the Health Products Act 2007 guidelines using the online Medical Device Information and Communication System (MEDICS) interface. Medical device companies will need to follow these new Singapore regulations to be successful there. Regulations in Singapore are normally strictly enforced.
February 1, 2009
Hong Kong is now a part of China, but as a special administrative region, Hong Kong has its own medical device regulations separate from China. Having only a few local device manufacturers, Hong Kong imports most of its medical devices. While there has been little legislative control over the import process in the past, recent changes to Hong Kong's medical device registration system suggest that there will be stricter requirements for medical devices in the future.
February 1, 2009
Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group of countries prepares to unveil a more unified approach to oversight.
Pacific Bridge Medical presents Managing Asian Cultural/Business Diversity, a 2008 webcast/webinar on cross-cultural issues for Western companies doing business in Asia.
Pacific Bridge Medical presents Updates on Singapore's Medical Device Regulations, a 2008 webcast/webinar on changes in Singapore's regulatory system for medical devices.
Pacific Bridge Medical presents ASEAN Medical Device Harmonization Trends, a webcast/webinar on the medical device regulatory environment in the Southeast Asian nations, including Indonesia, Malaysia, the Philippines, Singapore, Thailand, and Vietnam.
March 1, 2008
When medical companies think of bringing their products to the Asian markets, they typically think of larger countries like China, Japan, or Korea first. However, other smaller Asian countries such as Singapore and Malaysia can be worthwhile destinations as well. Although they have smaller populations, these markets all have well-developed healthcare systems and are receptive to advanced products. In addition, their medical device markets are growing rapidly and, in many instances, are more easily accessible to foreign manufacturers. Before venturing into these territories, however, regulatory professionals will need to keep track of current changes to be successful. This article discusses recent regulatory developments in Singapore, Malaysia, Hong Kong, the Philippines, and Taiwan.
November 1, 2007
This report helps medical device manufacturers and distributors better understand how to source from Asia. Topics covered include: how to identify manufacturers, how to perform due diligence, what to look for during factory visits, contract negotiations, regulatory requirements, logistics, quality control, and other issues related to the sourcing equation. This report will also offer advice on how to avoid and troubleshoot problems and pitfalls that may arise in the course of the sourcing process, as well as information about insurance, payment arrangements, freight forwarding, and customs.
Furthermore, we will include Microsoft Excel spreadsheet templates on CD-ROM with this report that will facilitate your transportation and shipping decisions when dealing with multiple SKUs being shipped in one container.
October 1, 2005
Pharmaceutical and medical device markets are expanding throughout Asia. This presentation covers the medical device and pharmaceutical markets in Taiwan, Hong Kong, Malaysia, Singapore, India and Vietnam, and provides country-specific information about drug, device and IVD regulations in these countries. Specific topics include registration, pricing and reimbursement, manufacturing and GMP, import licenses, patents, and clinical trials in these countries.
June 1, 2005
This presentation provides information on the medical device regulatory environments for Japan, China, Taiwan, Hong Kong, Korea, Malaysia, Singapore, the Philippines, and India. Some of the specific topics covered include Japans new Pharmaceutical Affairs Law (PAL) and Marketing Authorization Holder (MAH) System; the medical device registration process in China; and the reimbursement process in Taiwan.
May 1, 2005
Despite the country's small size, Singapore boasts a highly-developed economy and serves as an Asian hub for numerous medical companies. In total, Singapore's medical device and pharmaceutical markets are estimated at over $800 million. Leading pharmaceutical companies, such as GlaxoSmithKline, Pfizer, Eli Lilly and Bristol-Myers Squibb, have established a presence in Singapore and continue to expand their facilities. Pfizer chose Singapore for its first large-scale active pharmaceutical ingredient manufacturing facility in Asia, while GlaxoSmithKline set up its first Asia region preclinical research establishment in Singapore. In response to the growth of Singapore's medical industry, the Health Sciences Authority has been making great efforts to boost its regulatory expertise and improve the pharmaceutical and medical device regulatory environment in Singapore.
August 1, 2001
Despite sluggish economies in some countries, Asia still represents future growth opportunities in healthcare products. Over the next 20 years, Asian healthcare markets are expected to grow at a rate two and a half times that of the West. A rising standard of living throughout the region means patients will have the resources to acquire modern medical devices and pharmaceuticals. As the globalization of healthcare continues, regulatory practices for pharmaceuticals and medical devices will be further harmonized. This report examines emerging regulatory trends and issues in China, Japan, Hong Kong, India, Indonesia, Malaysia, the Philippines, Singapore, South Korea, Taiwan and Thailand.
July 1, 1999
Recovering economies throughout Asia offer promising markets for foreign medical device firms as well as opportunities for local product development and manufacturing. Before the Asian financial crisis, regional medical device markets grew at double-digit rates. Patients wanted the technologically innovative, cost-effective devices that foreign medical manufactures could provide. Many Asian countries became dependent on imports. Those factors strong demand and lack of domestic competition remained after the crisis. Furthermore, currency depreciation made it cheaper to establish local facilities for manufacturing and product development. This article features examinations of Japan, China, Singapore, Taiwan, India, Thailand and Malaysia.
July 1, 1998
Despite its currency crisis, Asia still offers manufacturers many opportunities.
Asia's recent currency crisis has caused some U.S. medical device companies to wonder whether there is still a market for their products and services. Concern has risen that Asians have lost their purchasing power, meaning a decrease in U.S. exports to Asia and an unstable economic environment in which to invest. However, not all manufacturers have fled the region. Several companies feel that the crisis has opened new opportunities for manufacturing in Southeast Asia.
November 1, 1994
An exceptional economic boom in the Asia Pacific region has spurred a large expansion in dental markets, providing remarkable prospects for foreign manufacturers of dental equipment. Dental hygiene and cosmetics have become major consumer health priorities as many more consumers can afford additional dental procedures. Japan is Asias largest dental market and even with the National Health Insurance (NHI) scheme covering only acute dental care, patients are willing to pay for many more non-acute dental procedures. Singapore boasts a high-technology dental system, encouraging neighbors from Indonesia, Thailand, Malaysia and the Philippines to come seek dental service. Hong Kong sustains a prosperous import market and plays an important role as the gateway to mainland Chinas dental market. This article highlights the major aspects of these three dental markets in Asia and the potential success for foreign dental equipment manufacturers in the region.
November 17, 1993
Singapore is one of the most technologically advanced societies among the ASEAN countries. Its extensive healthcare system, high health standards, comprehensive medical facilities and advanced medical market make the small city-state an ideal place for medical market investment. The Singapore Ministry of Health and the Singapore Economic Development Board (EDB) are responsible for the Singapore’s healthcare industries. They are working to promote Singapore as the premier regional medical center in order to attract even more foreign investors of specialized medical equipment. This article gives an overview of Singapore’s medical device market, healthcare system and the business climate for foreign medical suppliers.
October 1, 1993
This article is an overview of business opportunities for medical product manufacturers in the Asia Pacific region. Topics include Japan's import requirements, registration procedures, and the keiretsu system; Chinas slow decentralization of its healthcare system; the market growth of Indonesia, Thailand, Malaysia, Korea, Singapore and Taiwan; and business relationships between Western and Asian partners.
January 1, 1992
A basic guide to conducting business in China, Japan and Southeast Asia. Topics include personal and business relationships, negotiating, gift-giving, body language, introductions and language and cultural differences.
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