Publications : Malaysia

Pacific Bridge Medical has published numerous articles in leading trade journals pertaining to the medical market in Malaysia. 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.

2014 ASEAN Medical Device Update

By: Ames Gross
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.

2013 Malaysia Pharmaceutical Market Update

By: Ames Gross
May 27, 2013
The pharmaceutical market in Malaysia is worth $3.2 billion, about three times the size of Singapore's market. It is growing rapidly, at a pace of 11 percent per year. As Malaysia's economy booms, spending on healthcare is up. The country's 28.9 million people spend an average of $370 per year on healthcare, with about $70 of that devoted to pharmaceuticals. This is more than double the numbers from ten years ago. As per capita income rises, Malaysians are spending more of their disposable income on pharmaceutical products.

Malaysia Medical Device Market Update

By: Ames Gross and Catherine Matacic
February 6, 2013
Malaysia might not be the first country that comes to mind when medical device manufacturers want to export their products to Asia. However, the nation of 28.8 million has a medical device market of more than $1 billion, which is expected to grow 15.9 percent per year through 2017. Malaysia's market is driven largely by imports, especially for high-end products. As the country's wealth increases, Malaysian citizens will demand more and better medical devices. Demand will likely be met by imports over the next five to ten years.

Malaysia Pharmaceutical Market Updates

By: Ames Gross
February 1, 2012
The Malaysian drug market, currently valued at about $1.6 billion, is still relatively small but grown quickly. The pharmaceutical market is set to grow at about 7% between 2012 and 2014. Original branded drug sales, through retail pharmacies, comprised over 15% of the total pharmaceutical market in Malaysia in 2011. The pharmacy sector is currently valued at about $300 million with a Compound Annual Growth Rate of about 13%.

ASEAN Medical Device Regulatory Integration

By: Ames Gross and John Minot
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.

2008 Managing Asian Cultural/Business Diversity

October 23, 2008$400    Buy CD
Pacific Bridge Medical presents Managing Asian Cultural/Business Diversity, a 2008 webcast/webinar on cross-cultural issues for Western companies doing business in Asia.

2008 ASEAN Medical Device Harmonization Trends

September 9, 2008$400    Buy CD
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.

A Regulatory Update on Asia's Smaller Medical Device Markets

By: Ames Gross and Momoko Hirose
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.

Sourcing Medical Devices in Asia: An Introduction

By: Ames Gross and John Minot
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.

Drug and Device Markets throughout the Asian Region

By: Ames Gross
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.

Regulatory Updates for Medical Devices in Asia

By: Ames Gross
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.

Overview of Asia, Healthcare Markets and Regulatory Issues in the Region

By: Ames Gross
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.

Asia After the Crisis: Prospects for Foreign Medical Device Companies

By: Ames Gross and Gayatri B. Koolwal
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.

Updates on Malaysia's Medical Markets

By: Ames Gross
June 1, 1999
Thanks to significant government reform efforts since 1998, the Malaysian economy has been able to rebound from the Asian currency crisis of 1997. The costs of healthcare in Malaysia are on the rise and the government is looking to cut healthcare expenditure, while keeping medical services and procedures at a minimal cost for its citizens. In addition to healthcare amendments by the government, the Malaysian medical device market has been steadily growing and opening since the early 1990’s. Due to the very few trade barriers and regulations for imported medical equipment, the future for foreign medical device imports looks bright. This article discusses the changes the Ministry of Health (MOH) is making to amend the healthcare system, pharmaceutical regulations, medical device regulations and intellectual property laws. The continuing deregulation of the market will welcome foreign companies into Malaysia’s pharmaceutical and medical device markets.

Device Manufacturers Shouldn't Write Off Asia

By: Ames Gross and Gayatri B. Koolwal
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.

Malaysia's Device Market Growing 18% Annually

By: Ames Gross
April 14, 1994
This article gives a brief update on Malaysia’s medical device market. Malaysia’s medical device market is growing at a phenomenal pace, with foreign companies competing in the domestic market with virtually no local competition. Laboratory equipment such as spectrometers, X-ray apparatus and tubes, electrocardiographs, dental equipment, dental handpieces and patient monitoring equipment are the best pieces of equipment for foreign companies looking to invest in the medical market.

Asian Medical Products Markets Take Aim for an Economic Bull's Eye

By: Ames Gross
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.

Doing Business in Asia

By: Ames Gross
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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