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
Major new safety regulations set to take effect in South Korea in August include priority screening of biopharmaceuticals designed to treat rare diseases. The new safety regulations, instituted in the wake of a series of pharmaceutical safety scares, for the first time... Read More
With computer software increasingly central to the operations of many medical devices, Singapore’s medical authority is developing guidelines designed to ensure the quality of devices sold in the country which employ softwares. A draft of the guidelines released in late January by... Read More
Employing a raft of restrictive trade, financial, procurement, and insurance policies, Chinese authorities are increasingly insulating China’s domestic medical device industry from foreign competition. Beginning in 2018, China began to require that a growing number of state-run hospitals buy domestically produced medical... Read More
Medical device manufacturers will require the approval of Malaysia’s Medical Device Authority before they can advertise their products in the country, under a new regulation going into effect July 1. Under the regulation, applications must include a copy of the proposed advertisement,... Read More
After two years of delays, Taiwan’s legislature in January passed legislation establishing dedicated regulations on medical devices. The Medical Device Management Law, which has not yet been signed by Taiwan’s president, separates the regulation of medical devices from pharmaceutical products in the... Read More
Responding to concerns from medical device manufacturers, India’s national regulatory body for pharmaceuticals and medical devices has issued a clarification of what is considered an implantable medical device. Under a new definition published in December by the Central Drugs Standard Control Organization... Read More
Beginning in September, Japan will enforce recently codified amendments to its Pharmaceutical and Medical Device Act, affecting quality management, device registration, the regulation of medical software and third-party certifications. The new requirements, designed to guard against health problems associated with poorly regulated... Read More
Two years after Taiwan’s Food and Drug Administration first proposed establishing dedicated regulations on medical devices, efforts to separate oversight of the growing industry from that of pharmaceuticals remain stalled. Since 1973, when Taiwan established the Pharmaceutical Affairs Act, regulations of medical... Read More
As China’s drug market grows exponentially, more foreign API, excipient and drug packaging material companies look to sell their products in China. In August 2016, to simplify the drug review procedure, the former CFDA announced that the review and approval of APIs,... Read More