With some of the highest levels of national healthcare spending in Asia (ranking third after Vietnam and South Korea), Malaysia is taking hold of its strategic strengths in the pharmaceuticals and medtech sectors, among others, to expand the country’s economic growth. The... Read More
The Association of Malaysia Medical Industries (AMMI) is lobbying the government to change how the state affects the industry. Currently, the Malaysian government influences the medical device market by providing financial incentives for investments in R&D. AMMI, however, believes that the government... Read More
Introduction With the United States emerging very slowly from a huge recession, some of Europe unable to pay its bills, and more restrictions coming from the US Food and Drug Administration (FDA), an area where medical device companies may want to focus... Read More
On April 10, 2009, the Association of Southeast Asian Nations (ASEAN) Economic Ministers signed the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP). When implemented, GMP certification and inspection reports received in one ASEAN member nation (in accordance with... Read More
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... Read More
Managing Asian cultural and business diversity can be very complex for Western companies. Each country has its own culture, history, ideology, language and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and... Read More
Malaysia’s Ministry of Health will review private hospitals’ charges for medical devices and pharmaceuticals due to complaints of excessive fees. Currently, the Ministry has the Private Hospital Act to control medical expenditures. However, this Act only regulates doctors’ fees. The Ministry of... Read More
ASEAN industry members assembled in the Philippines in January 2008 to announce committee members of the new ASEAN Medical Device Industry Association (AMDIA). AMDIA is focused on representing the common regulatory interest of the medical device industry in ASEAN. It will also... Read More
Both local and foreign drug manufacturers will have to obtain pre-market approval with stringent testing to be certified fit for sale. Manufacturers must submit a document listing the benefits and function of the drug, including ingredients. Malaysia’s Health Ministry Food Safety and... Read More
The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following: To define a structure for disseminating medical device safety alerts among AHWP members;... Read More