Publications on Hong Kong
Pacific Bridge Medical has published numerous articles in leading trade journals pertaining to the medical market in Hong Kong. Our consultants and researchers are constantly identifying pertinent new medical device and pharmaceutical regulations, trends, and other information. The published articles, reports, and webcasts below are free or for purchase.
New Medical Device Regulations in Singapore and Hong Kong
Published by RAPS in Regulatory Focus
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.
Updates on Hong Kong's New Medical Device Regulations
Published in Pacific Bridge Medical Webcast
$400 | Buy Webcast
Like many other Asian countries, Hong Kong is developing a more regulated, harmonized system for medical device manufacturers and importers. Though registration is currently voluntary, in time manufacturers will be required to demonstrate conformity and register their products in order to do business. Get a head start by purchasing this webcast and familiarizing yourself with Hong Kong's emerging medical device framework.
A Regulatory Update on Asia's Smaller Medical Device Markets
Published by MPO
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.
Drug and Device Markets throughout the Asian Region (PDF)
Presented at the Orange County Regulatory Affairs Discussion Group
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.
Regulatory Updates for Medical Devices in Asia (PDF)
Presented at the MD&M East Conference
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 Japan’s new Pharmaceutical Affairs Law (PAL) and Marketing Authorization Holder (MAH) System; the medical device registration process in China; and the reimbursement process in Taiwan.
Overview of Asia, Healthcare Markets and Regulatory Issues in the Region
Presentation at Regulatory Affairs Professional Society (RAPS) Conference
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.
Opportunities in the Hong Kong Medical Market
Published in Clinica, a publication of PJB Publication, Ltd.
Hong Kong's large open market economy has been encouraging foreign trade for decades, including the importation of medical devices. The U.S., Japan, China and Germany are all leading exporters in Hong Kong's medical device market and the market is already worth well over $342 million, with expectations to increase. This article discusses the tremendous opportunities for foreign medical device suppliers in the Hong Kong medical market. The article includes information about the basic functions of the Hong Kong healthcare system, including the role of the Hospital Authority and the Government Supplies Department (GSD). Additionally, information regarding the future prospects of diagnostic equipment is mentioned, as there are no domestic producers in Hong Kong. Furthermore, increasingly high incomes in Hong Kong mean more spending on healthcare by its citizens and the government, which will provide abundant opportunities for success for foreign medical manufacturers.
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