Expectations from the Japanese Medical Device Industry for Outcomes of Regulatory Science in Japan

Abstract

Along with the slogan of “Medical Products for Overseas” by the Japanese government, we, i. e. International Policy and Strategy Committee at the Japanese industry, i. e. JFMDA (The Japan Federation of Medical Devices Associations) has been working together with Japanese government, MHLW (Ministry of Health, Labor and Welfare) and PMDA (Pharmaceutical and Medical Devices Agency) to harmonize medical device regulations with foreign countries since 2013. One of the challenge for Japanese medical device manufacturers is product registration when expanding their businesses abroad. Product registration is required in most countries under their own medical device regulations. However many Japanese companies are SME. So they did not always have enough human resources to handle Regulatory Affairs (hereunder “RA”) issues in house and/or “know-how” of product registration with foreign governments. Therefore, we assumed that lowering the level of such challenge might help them to expand their businesses outside Japan. To overcome this challenge, we think that improvement of regulatory science is very helpful for us. Because efficient and reasonable RA management skills and techniques can contribute to authorities in other countries, that may not have enough knowledge and experiences of RA, to provide new medical devices to their patients in a timely fashion. Through exchange activities of authorities between Japan and other countries, if such countries exempt some/whole either documents and/or data for medical product registration consequently, that would be a great help to Japanese medical device companies.