CHINESE DEMAND FOR CANCER MEDICAL DEVICES China has the second largest medical device market in Asia, valued at more than $14 billion with an annual growth rate near 15%. The device market is expected to double by 2025. At the same time,... Read More
Cancer is growing very quickly in China. At the same time, Chinese citizens are becoming wealthier and demanding higher quality medical products and services. Thus, Western medical device companies marketing their cancer products in China are seeing rapidly increasing demand. Western medical... Read More
Explosive demand for medical devices in the Asian markets are attracting Western and local medical device companies. Western medical device companies are increasing sales to Asia with basic models and lower costs of their top-of-the-line products. However, many more local Asian medical... Read More
The developing world is experiencing more Western diseases as they consume more Western products such as fast food, leading to a rise in the cardiology, orthopedics, and cancer rates. This means that the developing world is seeing a growing demand for devices... Read More
For Class B, C, and D medical devices (see Classification of General Medical Devices in Singapore), there are two submission routes in Singapore: the abridged submission route and the full evaluation route. The abridged submission route is only for medical devices that... Read More
For more information about Singapore’s regulatory framework, please see Singapore Medical Device Regulations. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge Medical (www.pacificbridgemedical.com) and, if possible, a... Read More
The U.S. Food and Drug Administration (FDA) has released several important documents. On September 16, 2014, the FDA released a final guidance for abbreviated new drug applications (ANDAs), explaining a variety of specific application deficiencies that may result in the FDA refusing... Read More
There are many new changes in the Japanese medical device regulations. Read More
Joko Widodo was inaugurated as the new President of Indonesia on October 20, 2014. One of the tough challenges Widodo’s administration will face is reforming the healthcare system. Indonesia has a complicated, decentralized healthcare system that spreads responsibility from the national level... Read More
In late September 2014, the Indian Health Ministry released several amendments to the country’s Drugs and Cosmetics Rules, effective immediately. Medical devices must now be labeled with information such as the device name, batch number, expiration date, manufacturing license number and address... Read More