Moving to strengthen its regulations of medical devices offered for sale in India, the nation’s medical device regulatory authority announced it will mandate the registration of eight categories of devices that did not previously require such approval. The decision by India’s Central... Read More
Moving to make complying with its emerging medical device regulations simpler, Hong Kong authorities have launched an online tool to help manufacturers of in vitro devices (IVDs) properly classify their products. The platform unveiled by Hong Kong’s Medical Device Control Office (MDCO),... Read More
Addressing the rapid development of in-vitro diagnostics technologies and their increasing usefulness, China’s National Medical Products Administration (NMPA) in November refined its system of classifying in-vitro diagnostic (IVD) devices to better reflect the varying levels of risk they contain. Under the new... Read More
Seeking to quell confusion over which of its regulatory agencies has purview over medical devices that are used in combination with pharmaceuticals, Malaysia’s Medical Device Administration (MDA) has released guidelines for classifying such products. The combination products, known as Medical Device Drug... Read More
Last month, the China National Drug Administration (CNDA), formerly known as the China Food and Drug Administration (CFDA), released a fourth batch of Class II and III medical devices that may be exempted from the requirement to conduct local clinical studies to... Read More
South Korean health authorities are slashing the amount of time required to approve new medical devices before they can be brought to market in the country. The shorter approval period, announced on July 19 by Korea’s Ministry of Food and Drug Safety... Read More
The China Food and Drug Administration (CFDA) (now NMPA) is the administrative body responsible for the regulation of medical devices and pharmaceuticals on the Chinese mainland. The CFDA is separated into various departments that are individually responsible for the registration, tracking, and monitoring... Read More
Japan’s Ministry of Health, Labor and Welfare (MHLW) is the regulatory body that oversees food and drugs in Japan, which includes creating and implementing safety standards for medical devices and drugs. In conjunction with the MHLW, the Pharmaceutical and Medical Device Agency (PMDA)... Read More
The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the chief governmental body responsible for overseeing medical device and pharmaceutical registration, manufacturing, and distribution in South Korea. The MFDS is tasked with... Read More
India’s Ministry of Health and Family Welfare (MoHFW) and the Central Drugs Standard Control Organization (CDSCO) are the main regulatory bodies that are responsible for overseeing pharmaceuticals and medical devices within India. The CDSCO exercises regulatory control over the import of drugs and... Read More