Moving to align its system for approving the sale of medical devices with those of other Association of Southeast Asian Nations (ASEAN) countries, the Philippines Food and Drug Administration in February announced new requirements for registering and regulating such products. The new... Read More
Medical devices purchased by public health establishments in Vietnam are subject to new regulations which took effect Sept. 1. The regulations mandate classifying medical devices into groups according to whether and to what extent they have been granted marketing authorization by regulatory... Read More
Chemical and biologic drugs are required to be classified into new categories for registration in China under new guidance issued by the Center for Drug Evaluation of National Medical Products Administration. Under the new classification system, which went into effect on... Read More
China’s pharmaceutical regulatory agency has changed the way it categorizes chemical and biologic drugs, according to a series of notifications that went into effect July 1. The new drug registration categories released by the National Medical Products Administration (NMPA) better delineate the... Read More
As part of its continuing effort to align its regulatory approach to drug registration and regulation with international practices, China is proposing modifications to the way it categorizes pharmaceuticals. The draft plans would be the first restructuring of registration classifications of chemical... Read More
Medical devices in Thailand will be classified in accordance with the risk they pose to patients and the public, under a new categorization system announced by the Ministry of Public Health. The move to create four categories each for both in vitro... Read More
In Thailand, medical devices are categorized in 1 of 3 classes in accordance with the ASEAN Medical Device Directive (AMDD). Sometimes, it is difficult to tell if a product is a medical device or not. In some cases, devices may have drug... Read More
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