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
Seeking to improve the safety, effectiveness, and oversight of medical devices, India’s government is again considering a series of laws that would establish a regulatory framework for medical technologies. But government health officials remain divided over which course to take to tighten... Read More
Healthcare facilities in Malaysia would be required to notify government authorities if they employ medical devices whose registration has lapsed, under a new guidance drafted by the country’s Medical Device Authority. The use of such “orphan” devices has been a recurring issue... Read More
Seeking to more effectively manage, distribute and ensure the efficacy of publicly funded vaccines, Chinese health authorities plan to institute a web-based national vaccine tracking system in the next three months. The system, piloted in seven major provinces last year, is designed... Read More
New drug therapies to treat serious and life-threatening diseases would be reviewed more quickly under draft regulations under consideration by China’s Center for Drug Evaluation (CDE). The proposed guidelines would allow for priority review and conditional approval of pharmaceuticals deemed to have... Read More