Publications on the Philippines
(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
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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.
Regulatory Updates for Pharmaceutical and Medical Devices in the Philippines
Published by Pacific Bridge Medical
Over the past few years, the pharmaceutical and medical device markets in the Philippines have been growing 6-8 percent annually. Both the pharmaceutical and medical device markets are largely made up of imported products, valued at around $300 million and $75 million, respectively. Currently, the U.S. has a limited presence in the Philippines’ pharmaceutical market, holding less than eight percent of the market share; the U.K., Germany, France and Switzerland each hold around 10 percent. However, since the Philippines’ drug regulatory body, the Bureau of Food and Drugs (BFAD), adopted U.S. Pharmacopoeia standards, U.S. pharmaceuticals should continue to have good market potential. Companies such as Pfizer, Wyeth and Eli Lilly all have a presence in the Philippines’ drug market. The U.S. plays a larger role in the Philippines’ medical device industry, currently possessing about 35 percent of the market.
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.
Philippines: Product Registration for Pharmaceuticals
Published by Pacific Bridge Medical
The Asian pharmaceutical market is constantly expanding with Korea, Japan and Taiwan leading the way. The Philippines is no exception and it is currently the fourth largest pharmaceutical market in Asia. In 1999 alone, the Filipino pharmaceutical market saw a 5% increase. The Pharmaceutical Healthcare Association of the Philippines (PHAP), an association comprised of local and multinational manufacturers, traders, distributors, and retailers, has set the standards for product registration in the Philippines. This article lists requirements for initial and conditional product registration in the Filipino pharmaceutical market.
Philippines: Year-End Medical Device Market Update 1999
Published by Pacific Bridge Medical
After the Asian financial crisis, the Philippine government pushed for economic reforms, bringing the economy’s growth rate to 3.8% in the second quarter of 1999. As the government continues its economic reforms, the government is further deregulating its market, making it more open to medical imports. The Philippines’ medical equipment market was worth $51 billion in 1998 and will continue to increase due to increased utilization of medical equipment and various other products. Currently, medical device product registration is required for each product and is overseen by the Bureau of Food and Drugs in the Department of Health. This article gives a detailed update of the medical device market in the Philippines and explains the requirements for medical device registration and renewal.
Opportunities in the Philippine Medical Market
Published in Clinica, a publication of PJB Publications, Ltd.
This article gives an overview of the growing prospects for foreign companies in the Philippine medical device market. The government and the Department of Health (DOH) are encouraging greater investment of medical equipment, devices and pharmaceuticals under the proposed Investment Priorities Plan (IPP). The medical equipment market, medical instrument sector and the Department of Health’s national healthcare system are some of the topics covered.
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