Publications on Malaysia
(Free and For Purchase)
ASEAN Medical Device Regulatory Integration
Published in MPO
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.
ASEAN Medical Device Harmonization Trends
Published in Pacific Bridge Medical Webcast
$400 | Buy Webcast
Regulatory harmonization, post-marketing surveillance schemes, and a Common Submission Dossier Template are just some of the new plans the Association of Southeast Asian Nations (ASEAN) has been working on recently. Are you aware of the newest regulations and trends in Southeast Asia? Though some of these nations' medical device regulations have been minimal or nonexistant in the past, increased regulation and rapid change are now underway.
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.
Drug, Device and Cosmetic Regulations in Malaysia: 2005 Update
Published by Pacific Bridge Medical
The healthcare industry in Malaysia is currently valued at around $1 billion and growing at a steady rate of 6-8 percent annually. The country still imports more than half of its pharmaceuticals and medical equipment, with the U.S., Japan and Germany as its largest importers. The Malaysian government considers the country’s healthcare industry as one of its top priorities, and continually strives to implement new schemes to help boost the country’s medical sector. This article provides an overview of the pharmaceutical, medical device and cosmetic regulatory environments in Malaysia.
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.
Regulatory Update on Malaysia's Medical Markets
Published by Pacific Bridge Medical
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.
Malaysia's Device Market Growing 18% Annually
Published in Clinica, a publication of PJB Publications, Ltd.
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.
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