Eager to encourage the development within its own borders of pharmaceuticals to meet urgent health needs of its people, Japan’s health authorities have begun discussions on establishing an emergency approval system modeled on that of the United States. While a legal pathway... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. This article was originally published on MedTech Intelligence. Japan is still the third largest medical device market in the world, after the United States... Read More
The Japanese Ministry of Health, Labor and Welfare issued a notice on September 29, 2021 that stated that Japan has decided to formally start accepting MDSAP reports for medical devices and IVDs as part of the Japanese QMS process for product registration... Read More
A working group established in April by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is tackling the knotty issues of how best to employ real-world data (RWD) in formulating regulations of orphan drugs and other novel treatments under development for patient populations... Read More
Japan’s health agencies in September released a set of goals for encouraging the development of life-saving drugs, speeding clinical trials, and encouraging medical research and technological advances. Developed by the Ministry of Health, Labor, and Welfare (MHLW), the strategy document, the Pharma... 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
Alarmed by increasing blockages in the supply chain of prescription drugs, the Japanese government is considering requiring manufacturers to alert the government to anticipated shortages of their products. Such a mandate, floated in recent interviews by health officials, would require passing legislation.... Read More
For the first time, regulators in Japan are carrying out surprise inspections at facilities where pharmaceutical and medical device products are manufactured. The inspections, which began in August, are designed to improve Japan’s system for ensuring the products are consistently produced according... Read More
Seeking to topple long-standing obstacles to drug innovation in Japan, pharmaceutical industry leaders in the country have outlined a slate of steps they propose the government take to foster research and development of new products, trim regulations and approval times, and speed... Read More
Contact us today to learn more about how Pacific Bridge Medical can help you file a device MF in Japan. Background information The original Japanese Device MF system was established in December 2000. This system is called the “Old MF system”. At that... Read More