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Asia is emerging from the global recession faster than other regions in the world. This article goes through some of the major regulatory updates in various Asian countries. 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

R&D in Asia has the potential to significantly improve the global performance of medical device companies by cutting costs and speeding product development--but extensive due diligence is required for success. 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

In October 2008, Singapore’s Health Sciences Authority (HSA) released a draft guidance document for In Vitro Diagnostic (IVD) medical device product registration applications. The HSA implemented the new Common Submission Dossier Template (CSDT) for medical device registration in late 2008 as part... Read More

Hong Kong is now a part of China, but as a special administrative region, Hong Kong has its own medical device regulations separate from China. Having only a few local device manufacturers, Hong Kong imports most of its medical devices. While there... Read More

Singapore’s Health Sciences Authority (HSA) drafted a stricter set of guidelines in October 2008 for advertising and promoting medical devices in Singapore. These new guidelines coincide with Singapore’s recent implementation of an updated medical device regulation framework. They are meant to complement... Read More

Singapore’s Health Sciences Authority (HSA) recently implemented a new phase in their updates to Singapore’s medical device regulatory framework. This phase brings Singapore a step closer to a mandatory registration system for medical devices. Singapore’s system will also eventually be implemented in... 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

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