China’s law (Implementing Regulations of the Drug Administrative Law) is currently being updated and out for public comments until June 9. The draft regulation includes over 181 articles or over 100 more articles than the current law. Some possible changes among other... Read More
On April 1, Malaysia’s Medical Device Authorities (MDA) issued a guidance document further classifying devices into 3 categories – 1. Non-invasive medical devices, 2. Invasive medical devices, and 3. Active medical devices. In addition to these categories, a number of new rules... Read More
As software as a medical device (SaMD) gains significant traction in Singapore, the HSA has recently issued Guidelines on the Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software. This guideline, which references the International Medical Device Regulatory Forum’s (IMDRF)... Read More
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