Software as a medical device (SaMD) may be eligible for conditional early review and approval in Japan including diagnostic imaging software and therapeutic apps. Japan’s Pharmaceutical and Medical Devices Law, approved this year, permits manufacturers to get their products rapidly approved even... Read More
Qualified research institutions that develop their own pharmaceuticals will be eligible to hold marketing authorization permits in China under new legal guidance that went into effect in late September. Since 2015, when China first began implementing its Marketing Authorization Holder (MAH) system,... Read More
A long-anticipated new law tightening government control over the quality of medical devices went into effect in South Korea in October. Also, a Medical Devices Renewal Program imposes requirements that all medical devices offered for sale in the country be reviewed periodically... Read More
Moving to speed the approval of needed pharmaceuticals, the Philippines health authorities are making it possible to register some vaccines, biologicals, and other drugs for sale in the archipelago nation if they have already met approval requirements abroad. The order issued in... Read More
Following the lead of the United States, the European Union, China and other countries, Singapore is establishing a Unique Device Identification system for medical devices. The system is scheduled to be required first on high-risk implantable devices beginning in 2022, and on... Read More
Moving to better codify regulations on its growing medical device industry and market, the Indian government in September proposed making 24 categories of medical devices subject to risk-based assessments. The effort by India’s Central Drugs Standard Control Organization (CDSCO) is designed to... Read More
Medical devices may not be promoted or advertised to healthcare professionals or institutions in Thailand without permission from appropriate regulatory authorities, according to a directive issued in November by the country’s Food and Drug Authority. The guidelines on direct advertising were among... Read More
Medical devices which employ artificial intelligence and machine learning will be subject to new inspection and registration guidelines in Taiwan, according to directives published in October by Taiwan’s Food and Drug Administration. The new structures are designed to ensure that medical device... Read More
In response to growing concern that pharmaceuticals imported to China do not always adhere to the same safety guidelines they follow when marketed abroad, Chinese health authorities in October put forward a proposal to update domestic regulations governing drug recalls. The proposed... Read More
Moving to better ensure the safety and efficacy of medical devices offered for sale in Thailand, the country’s Food and Drug Administration (FDA) in October issued a list of technical specifications for devices that must be presented to authorities on request. Under... Read More