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
Moving to clarify and speed the process of registering medical devices in Singapore, the country’s Health Sciences Authority (HSA) has instituted an interactive tool that applicants can use to smooth the entry of products into its strictly regulated market. The tool uses... Read More
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