Over the last few months, Japan has upgraded regulations for labeling for medical devices and pharmaceuticals. In mid-September, Japan promulgated new regulations for regenerative products outlining the labeling requirements on containers for – 1. individual unit packaging, 2. the unit of packaging... Read More
By this past October, device manufacturers and importers of Class A medical devices are required to register their products via an online portal. The manufacturer or importer will also need to confirm that their device meets the requirements of the essential principles... Read More
Starting on November 1, 2022, China’s NMPA will issue electronic drug certificates for marketing authorization, clinical trials, drug renewals, chemical APIs, etc. The electronic certificate will be as valid as a paper certificate. To be eligible for electronic certificates, drug applicants must... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) recently announced a new program titled – Global Innovative Products on Fast Track (GIFT) which is similar to the US FDA’s breakthrough therapy designation system. The GIFT program is in addition to the already... Read More
Last month, we reported that the Japanese MHLW has outlined a new accelerated pilot system for SaMD products. In late October, the MHLW working group for SaMD products met with 3 groups – 1. the Japan Digital Health Alliance, 2. the Japan... Read More
This past summer, Korea issued article 43-6 of the Medical Device Act, requiring medical device manufacturers and importers to obtain liability insurance for patient claims of injury or death. For now, only manufacturers or importers of implantable device products are required to... Read More
In mid-October, the Japanese government’s healthcare digital transformation group met to revise reimbursements and increase reimbursements in the digital space. The government hopes to increase cost-effectiveness through digital medical fee revisions. The government has 3 targets including – 1. implementing medical reimbursement... Read More
In early October, Malaysia’s Medical Device Authority (MDA), has released a guidance document for companies in the medical device space. An Establishment License delineates the local requirements for manufacturing, exporting, and importing of devices in Malaysia. The guidance document provides definitions for... Read More
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On September 2, the Japanese MHLW outlined a new accelerated pilot system for SaMD products. Japan already has a priority system called Sakigake, but this system has four main criteria and is not focused on SaMD products. This new pilot system only... Read More