To be successful in the Singaporean market, medical companies will need to understand the local culture and learn how to conduct business properly there. View this presentation for a comprehensive overview of Singaporean business culture and HR issues. To view these presentation... Read More
In line with recommendations from the Global Harmonization Task Force, the Singapore Health Sciences Authority (HSA) has implemented two new evaluation routes for Class C and Class D medical devices in Singapore as of January 1, 2013. Previous Routes: Full Evaluation Route:... Read More
Singapore has experienced explosive growth in its medical technology industry over the last decade, growing from about US$750 million in 2000 to over US$4 billion in 2012. This growth, coupled with Singapore’s highly educated, high-tech workforce, has led to significant new medical... Read More
ASEAN (Association of Southeast Asian Nations) recently released a draft of the ASEAN Medical Device Directive (AMDD) for comments in August 2012. This draft aims to enhance and harmonize medical device regulations among member countries. ASEAN plans to implement the Directive by... Read More
The Association of Southeast Asian Nations (ASEAN) is set to introduce the ASEAN Medical Devices Directive (AMDD), a uniform set of regulations that will cover all 10 of its member states. The AMDD will be written based on the Global Harmonization Task... Read More
Innovator pharmaceutical companies will soon have their branded sales heavily affected in the Asian pharmaceutical markets. This is due to the fact that pharmaceutical products collectively expected to generate $21 billion will go off patent over the next five years. Brand pharmaceutical... Read More
Singapore’s Health Sciences Authority (HSA) and Malaysia’s National Pharmaceutical Control Bureau (NPCB), the pharmaceutical regulatory body within the Malay Ministry of Health (MOH) recently signed a memorandum of understanding (MOU) on pharmaceutical regulatory matters. This is the first health sector MOU signed... Read More
Singapore’s Health Sciences Authority (HSA) classifies medical devices into 4 classes according to its intended use and the risks associated with its use. The HSA passed a number of medical device regulatory changes to facilitate the market entry of lower-risk Class A... Read More
The Singapore Health Sciences Authority (HSA) released an announcement that QMS requirements for Class A medical devices have been reduced. Essentially, all that is required now is a signed Declaration of Conformity. Foreign device companies have complained about the difficulty of fulfilling... Read More
On November 12, 2011, the United States and eight other countries jointly announced the outline for a new Trans-Pacific Partnership (TPP) on trade and investment. This landmark partnership aims to coordinate economic activity, regulatory standards, and tariffs in all trade areas. In... Read More