On March 31, the Japanese MHLW issued a notification allowing CDxs to be used for more than one drug, in addition to the initial treatments they were originally approved for. In the past, different CDxs were available for unique drugs that have identical indications. ... Read More
Singapore’s Health Science Authority (HSA) recently announced regulatory updates pertaining to the two Special Access Routes GN-26 and GN-27. GN-26 allows licensed healthcare providers to import unregistered medical devices to use on their patients. GN-27 allows licensed importers to import unregistered medical... Read More
Malaysia’s MDA regulatory body, founded a decade ago, has concluded the public comments period for parties interested in submitting feedback on its new medical device guidance, MDA/GD/0009. Offering numerous examples, MDA/GD/0009 provides classifications of medical devices known as active, invasive and noninvasive,... Read More
Moving to streamline requirements for the approval, licensing, and management of medical devices, Vietnam is now requiring all classes of the devices to be registered with government regulatory authorities. But under a new law that goes into effect January 1, device registration... Read More
In its latest move to better control the safety of medical devices for sale in India, regulators announced in September that a range of devices used in hospitals will be classified into six separate areas for the purpose of assessment and registration.... Read More
Telegraphing a desire to smooth the regulatory process for the growing ranks of software as a medical device (SaMD) product, a top Japanese regulatory agency official said the products will be evaluated as medical devices if they are designed to be used... Read More
With the use of standalone software as a medical device (SaMD) rising rapidly in Singapore, the country’s health authorities in July unveiled a draft roadmap of regulatory guidelines on software or mobile apps which have a medical purpose and invited public consultation... Read More
On July 8, 2021, the China National Medical Products Administration (NMPA) issued Announcement No. 47 to provide guidelines for the classification and regulatory submission of Artificial Intelligence (AI) medical devices. The announcement distinguishes whether an AI product is a medical device or... Read More
In a long-anticipated move toward tightening and streamlining approval requirements for medical devices, Vietnam’s Ministry of Health announced in May that approval of Class B, C, and D medical devices will soon be required to use the ASEAN Common Submission Dossier Template... Read More
New guidelines on software applications released by Japanese regulators seek to help manufacturers and consumers understand which programs, features, and products constitute a medical device, and how such products—increasingly prevalent in the Japanese market—will be regulated. Released in March by the Ministry... Read More