Publications on Indonesia
Pacific Bridge Medical has published numerous articles in leading trade journals pertaining to the medical market in Indonesia. 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.
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.
Indonesia Pharmaceutical Regulatory Update
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.
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.
Indonesia Year-End Medical Device Update - 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.
Opportunities in the Indonesian Medical Market
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.
Blog/RSS