Chinese regulators have mandated that all drug wholesalers conduct an internal investigation into storage and transportation practices. Wholesalers that discover violations were ordered to report their findings to the China Food and Drug Administration (CFDA) by May 31, 2016. This campaign is... Read More
According to the Korea Herald, Korea’s Ministry of Food and Drug Safety is examining the possibility of allowing the limited use of 3D printed medical devices in one-time emergency situations. This would allow doctors to print devices for patients who have exhausted... Read More
According to a news report from the Business Standard, Japanese and Indian medical device and pharmaceutical regulators met in New Delhi in May to discuss potential collaboration efforts. Participants in the two day conference agreed to cooperate further, and Japan invited Indian... Read More
While the new Drugs and Cosmetics Bill 2015 was introduced to the Indian Parliament late last year, lawmakers in India’s lower house have yet to approve the legislation. The Drugs and Cosmetics Bill 2015 would overhaul many existing medical device regulations and,... Read More
In early May 2016, the China Food and Drug Administration (CFDA) issued two new announcements that will raise the industry standards for medical devices. Of the 186 total new standards, 42 are mandatory while the remaining 144 are recommended. These standards will... Read More
Last year, the China Food and Drug Administration (CFDA) issued a number of regulations for drug clinical trials. This year, the CFDA is continuing its long-term regulatory overhaul by improving medical device regulations. In May 2016, the CFDA released three documents that... Read More
Japan has become the second largest market for in vitro diagnostics (IVD) in the world. In Japan, the Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceutical Medical Devices Agency (PMDA) are the two main regulatory authorities that manage pharmaceuticals, medical... Read More
The in vitro diagnostics (IVD) market in China is growing very quickly. In China, the China Food and Drug Administration (CFDA) is the main agency that oversees drugs, medical devices, and IVDs. However, there is currently no formal IVD consultation process in... Read More
The Association of Indian Medical Device Industry (AIMED) recently established a new program called the Indian Certification of Medical Devices Scheme (ICMED). Previously, there was no specific quality assurance system in India. This new scheme will standardize the level of quality for... Read More
China recently released its 13th Five Year Plan. China’s Five Year Plan lays out broad based goals that the country hopes to achieve in the coming years. The most important objectives laid out in the medical devices, pharmaceuticals, and healthcare section include:... Read More