By: Ames Gross
February 1, 2012
Published by Pacific Bridge Medical
The Indonesian pharmaceutical market was estimated to be around US$4 billion in 2011. The countrys pharmaceutical market has been steadily growing. Along with increased domestic demand, sales of prescription drugs are expected to grow approximately 12% in 2012, according to IMS Health data. Growth in prescription drugs will be higher than over-the Counter (OTC) drugs, which are only forecasted to grow 5.7%.
By: Ames Gross and John Minot
February 1, 2009
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.
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 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.
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 and Rachel Weintraub
July 1, 2005
Published by Pacific Bridge Medical
The pharmaceutical market in Indonesia is currently valued at around $350 million. More than 50 percent of the market is comprised of imported products, with a large portion coming from the U.S., Germany, Switzerland and Japan. Foreign companies importing finished products or raw materials into Indonesia are required to obtain an import license from the Ministry of Health. The National Agency of Drug and Food Control (NA-DFC) is responsible for ensuring the safety, quality and efficacy of pharmaceuticals in Indonesia. The NA-DFC also handles the drug application review process and grants drug approvals in the form of a marketing authorization license.
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
December 1, 1999
Published by Pacific Bridge Medical
Since 1997, Indonesia has battled its worst economic crisis in decades. Therefore, it is no surprise that Indonesia's healthcare industry is facing significant challenges. This article discusses the medical device market in Indonesia and its potential for growth. The medical device registration process is described, providing details of the two-step process required for registration.
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
February 14, 1994
Published in Clinica, a publication of PJB Publications, Ltd.
Through an increased prosperity from export earnings, the Indonesian government has been able to focus more attention towards enhancing living standards. Hospitals have access to technologically-advanced equipment and public health centers are growing at a rate of about 4% per year. In 1993, Indonesia's medical device market was worth approximately $105 million. This article describes the medical device situation in Indonesia and the government's role in medical device purchasing and registration procedures.

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