The majority of medical and in-vitro devices sold in Japan will be required to post package insert information to a website maintained by the country’s Pharmaceuticals and Medical Devices Agency, in accordance with a new regulation going into effect on August 1.... Read More
In an across-the-board effort announced by the Chinese government in May, the country’s health regulators are making plans to strengthen oversight of the manufacture, import and distribution of pharmaceuticals. The announcement from the General Office of the State Council outlined a range... Read More
Taiwan’s long-anticipated new law regulating medical devices modifies the way devices are classified, mandating they be grouped by product category and risk, adjusts device registration fees, and mandates adherence to certain technical guidelines for preparing documents related to device registration applications. The... Read More
Moving to systematize the settling of patent disputes, Chinese health regulators are testing an online patent linkage system designed to connect the approval for marketing of generic drugs with the expiration of innovative drug patents. The system puts into effect patent linkage... Read More
Advertising rights in Malaysia will be granted only for medical devices that have obtained registration permits from the country’s health regulators, according to new guidance published in April by the country’s Medical Service Authority (MSA). The guidance is designed to ensure that... 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
Medical research in China involving humans will be subject to ethical reviews to ensure privacy, safety, and fairness, if a draft proposal released by the National Healthcare Commission (NHC) becomes law. The proposal would require research and healthcare institutions to create or... Read More
Continuing to refine its nascent laws regulating the sale of medical devices and IVDs, Vietnam’s Ministry of Health in March drafted new legal parameters that tighten controls on classifying, testing, and conducting clinical trials of medical devices. As drafted, the new regulations... 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
By December 1, 2021, according to the NMPA’s recent release on new Pharmacological Vigilance Quality Management Standards, Marketing Authorization Holders (MAHs) in China will have new pharmacological vigilance responsibilities. MAHs will need to have a dedicated pharmacovigilance team to deal with risk... Read More