Archives
Japan Outlines New Medical Device Cybersecurity Regulation
On March 9, 2023, a new regulation for ensuring cyber security was issued in the Essential Requirements Criteria in Japan. The Essential Requirements Criteria’s Article 12 already had 2 clauses, but clause 3 on cybersecurity has now been added. In short, medical... Read More
India Delays Some Medical Device License Requirements
In 2020, India promulgated their Medical Device Rules Act. This act increased registration requirements in India. Before the act, only about 35 device categories required registration. After the act, all previous non-regulated devices now need CDSCO approval. Initially, non-regulated Class A and... Read More
Digital Health Growing in Japan
Currently, while digital health is very prevalent in the West, it is still at an infant stage in Japan. However, this is changing now. In 2020, a startup in Japan called Cure Up received regulatory approval for its nicotine addiction treatment. Also,... Read More
India Plans to Increase its Medical Device Production
Two weeks ago, India’s Union Cabinet, the top decision-making body in India, authorized a new medical device policy to increase its domestic device production. Currently, India only makes about 1% of the world’s medical devices and this new policy aims to increase... Read More
Japan’s PMDA FY 2024 Plan Expedites SaMD Review
At a March 13 PMDA meeting, the priority review time for SaMD products was set at 6 months. SaMD products with strong effectiveness will enjoy SaMD priority review if the SaMD product is submitted first in Japan or simultaneously with other global... Read More
Vietnam’s MOH Issues Decree #07 for Medical Devices
Replacing decree #98 with decree #07 will implement new device regulations in Vietnam. To help alleviate price fluctuations of devices in Vietnam, Vietnam initiated a policy that device traders or manufacturers need to list device prices on the Vietnam medical device portal... Read More
China Has New Medical Electric Standards for Medical Devices
In April 2020, China’s NMPA issued GB 9706 for medical electric standards to take effect on May 1, 2023. On March 16, 2023, the NMPA promulgated – A Notice on the Implementation of GB’s 9706.1 – 2020 and supporting standards. This regulation... Read More
China’s Medical Device Market Still Growing but Harder to Succeed There
While China’s device market is still growing in double digits, several factors have made it harder for foreign companies to succeed there. China wants to make more of its own devices and export them to the rest of the world. The Chinese... Read More