In late June 2014, the FDA released a draft guidance entitled Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. The guidance announced that these types of systems and devices would no longer need to comply with some... Read More
India -- which has a population of 1.2 billion -- is the third largest medical device market in Asia. The total market for diagnostic and medical equipment in India is worth about $3.5 billion and is expanding at an annual rate of... Read More
On June 1, 2014, China's amended "Regulations on the Supervision and Administration of Medical Devices" went into effect. Class I medical devices -- domestic and imported -- no longer need to be registered with the China Food and Drug Administration (CFDA). Instead,... Read More
After a drug has been approved by the China Food and Drug Administration (CFDA), it can take another year and a half until the pharmaceutical product can actually be prescribed by a doctor. To shorten this process, some drug companies begin the... Read More
Registration of medical devices is not mandatory in Hong Kong. However, Pacific Bridge Medical believes that all medical device companies marketing their devices in Hong Kong should register their products now. Read More
Economic growth in Asia will be almost 6% in 2014 (excluding Japan), compared with 1.5% in the EU and 2.5% in the U.S. Asia's growth will be led by China, which is expected to expand over 7% this year. The economies of... Read More
The election of Narendra Modi as Prime Minister of India should bode well for Western medical companies. As Chief Minister of Gujarat, Modi's policies led to considerable economic growth and development in the province. He was elected Prime Minister in large part... Read More
Japan has unique social customs and a distinct group mentality that greatly affects how business is conducted there. Western medical companies looking to expand to Japan will first need to properly understand Japanese business culture and etiquette. This presentation covers various essential aspects... Read More
China's meteoric economic development over the past 30 years has resulted in massive environmental pollution. Although national and local governments are taking steps to reduce the amount of pollution around the country, the issue remains a hot topic in China. Pollution leads... Read More
The Chinese pharmaceutical market was worth an estimated $75 billion in 2013. The market grew 20% year after year during the past decade and is projected to continue expanding at the rate of 17.5% per year through 2020. Currently the third largest... Read More