A Malaysian law requiring companies that manufacture or market medical devices in the country to register with the government goes into full effect this month, six years after it was first passed. The 2012 law was designed to bring Malaysia, which imports... Read More
In March 2018, India’s Department of Pharmaceuticals published guidelines proposing that domestic-made components make up 25 to 50 percent of medical devices procured by the government. The 25 percent requirement would apply to medical electronics, hospital equipment, surgical instruments, and diagnostic reagents/in-vitro... Read More
While China-wide shutdowns for major holidays have significantly decreased in recent years, they still have a big impact on sourcing and manufacturing chains in the United States. Chinese New Year in particular greatly impacts timeframe and quality issues, especially for sensitive medical... Read More
Following the example of the U.S. FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislation, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law. While... Read More
Introduction Despite its small population of 5.6 million, Singapore is a key drug market for Western pharmaceutical companies. Singapore’s pharmaceutical market is currently estimated to be about $820 million. It is expected to grow at a steady rate of 6% in 2017,... Read More
There are several steps to consider when entering the Asian medical device market. This presentation covers 10 essential steps to help grow your business in Asia. Case studies will be used to demonstrate key points. To view these presentation slides, please click... Read More
In January, 2017 the China Food and Drug Administration (CFDA) released a new industry standards report on quality management for medical devices. The new and updated requirements are intended to emphasize the importance of adhering to CFDA regulations. The quality management system... Read More
Historically, there have been multiple invoices at different levels for selling drugs in China. Such multiple invoices have led to big mark-ups and some dishonest behavior in the marketplace. Thus, in mid 2016, the Chinese government released Circular 26, detailing plans to... Read More
Multiple countries in the APAC region have been experiencing outbreaks of preventable diseases in 2016. The number of Singapore’s measles cases doubled in the first half of 2016 compared to the same time period in 2015, while Malaysia’s tripled from 2015 to... Read More
Under the Medical Device Act of 2008, companies with registered medical devices (business operators) must prepare and submit reports about malfunctions experienced by medical devices to the Thai Food and Drug Administration (FDA) concerning devices they manufacture, import, sell, or where the... Read More