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3月24日2014年，中国食品药品监督管理局（CFDA）宣布开展5个月的全国医疗器械质量问题的清理工作，提高医疗器械的产业标准。该活动将着重在二，三类医疗器械生产，销售以及使用领域中进行。2013年中国医疗器械市场价值约为130亿美元。然而，医疗器械市场的快速扩张，也意味着出现更多的医疗器械质量问题。 Read More

Japan is the second largest medical device market in the world. Getting through the registration process and selling your product on the market is not an easy task. This webcast will focus on key steps including PMDA consultation sessions, how to maximize... Read More

The US FDA will increase inspections of Indian drug and medical device manufacturing facilities in response to growing concerns about the quality of Indian medical device and pharmaceutical products. In mid-September, the agency issued the latest of many import alerts against Indian... Read More

Starting July 1, 2013, all new pharmaceutical companies operating in China must comply with China’s Food and Drug Administration (CFDA) revised Drug Quality Control Standards for license approval and GMP certification. Pharmaceutical companies with new, expanded or renovated warehouses or business locations... Read More

Starting July 2, 2013, the European Commission will require all Active Pharmaceutical Ingredient (API) manufacturers to meet EU current good manufacturing practice (CGMP) standards before importing products into the EU. The new regulations were passed in 2011, but countries from India to... Read More

Previously, China was associated primarily with low tech components and disposable medical devices. But over the last five years, Chinese manufacturers have made considerable strides in both medical technology and product quality. High end products like diagnostic imaging technology can now be... Read More

In its 2014 budget request, the US FDA is seeking an additional $10 million to increase its food and drug inspections in China. More than $4.7 million of the increase would go toward the drug inspection office. The China drug office hopes... Read More

Despite a recent drop in economic growth, China's economy is still growing. GDP growth in 2013 is expected to reach 7.3 percent, higher than anywhere in Asia. China's medical device market is currently the sixth largest in the world. If current growth... Read More

The newly revised Good Supply Practice for Pharmaceutical Products (GSP) was adopted at the executive meeting of the Ministry of Health and will go into effect on June 13th, 2013. The revised rules establish higher standards for quality controls in drug distribution... Read More

In a globalized world, many international medical device companies choose to source or manufacture their devices in Asia. Relatively low labor costs, low overhead costs and improving technical capabilities are all reasons for making the move. Labor costs have risen significantly in... Read More