By: Ames Gross
February 27, 2013
Published by Pacific Bridge Medical
The medical device market in Hong Kong reached about $850 million in 2012, and it is expected to grow at an annual rate of 8.5 percent for the next five years. This is a good sized market, considering Hong Kong's small population of 7 million and its geographic size of less than 430 square miles. Hong Kong boasts one of Asia's highest rates of income per capita, and healthcare spending as a percentage of gross domestic product is 6 percent. Hong Kong has no legislation in place that covers all medical devices. But it does have a voluntary registration system that will likely become mandatory in 2013 or 2014. International medical device manufacturers should understand this system, and they should carefully consider the advantages that come from registering products while the system is still voluntary.
Webcast by Pacific Bridge Medical
Pacific Bridge Medical presents Hong Kong Medical Device Regulatory Update, a 2012 webcast/webinar on Hong Kong FDA regulations.
By: Ames Gross and Arthur Chyan
October 1, 2010
Published in MPO
Hong Kong's government currently does not strictly regulate most medical devices. In August 2010, Hong Kong's Medical Device Control Office proposed its framework for comprehensive and mandatory regulation of medical devices and in-vitro diagnostic medical devices. There are many similarities to the MDACS of 2004. As with the MDACS, the new framework significantly draws from the Global Harmonization Task Force (GHTF) and the World Health Organization.
By: Ames Gross
February 1, 2009
Published in Regulatory Focus by RAPS
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.
Webcast by Pacific Bridge Medical
Pacific Bridge Medical presents Managing Asian Cultural/Business Diversity, a 2008 webcast/webinar on cross-cultural issues for Western companies doing business in Asia.
Webcast by Pacific Bridge Medical
Pacific Bridge Medical presents Updates on Hong Kong's New Medical Device Regulations, a 2008 webcast/webinar on Hong Kong's recent regulatory changes for medical devices.
By: Ames Gross and Momoko Hirose
March 1, 2008
Published in 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.
By: Ames Gross and John Minot
November 1, 2007
Published in RA Focus
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.
By: Ames Gross
October 1, 2005
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.
By: Ames Gross
August 1, 2001
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.
By: Ames Gross and Gayatri B. Koolwal
July 1, 1998
Published in Medical Device & Diagnostic Industry Magazine
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.
By: Ames Gross
November 1, 1994
Published in Clinica, a publication of PJB Publications, Ltd.
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.
By: Ames Gross
October 6, 1993
Published in Clinica, a Publication of PJB Publications, 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.
Back to Top