Japan Medical Device Regulations All documents listed below were published by the Ministry of Health Labour and Welfare MHLW or the Pharmaceutical and Medical Devices Agency PMDA and are in PDF format. The PMD Act provides the legal framework for the regulation of medical devices in vitro diagnostic reagents pharmaceuticals drugs and cosmetic products as well as regenerative and cellular therapy products in the Japanese market.

Japan Medical Device Approval Chart Emergo

Complying with the PMD Act can be challenging for foreign manufacturers as very few regulatory documents are published in English.

Japan medical device regulations. Japan Medical Device Nomenclature JMDN Codes Broadly based on Global Medical Device Nomenclature GMDN JMDN codes are regulated List maintained by Japan Association for the Advancement of Medical Equipment JAAME Used to determine pathway GMDN JMDN 14. As a foreign manufacturer you do not have to demonstrate home country approval to have a medical device authorized in Japan. Manufacturers must also follow and comply with Regulation MHLW No.

This Regulation lays down additional requirements for a quality management system for manufacturers certified to the ISO 13485 standard. To register a medical device in Japan a foreign manufacturer needs to submit a complete dossier that includes an application with attachments and a Summary Technical Document STED. Global Medical Device Nomenclature 窶 Implemented in 2005 窶 Not updated simultaneously with current GMDN 窶 MHLW creates new JMDN referring to current GMDN when a medical device which doesn窶冲 meet any of existing JMDN is approved 7 As of January 2016.

Medical device companies interested in offering their products in Japan must comply with Japans Pharmaceuticals and Medical Devices Act PMD Act. Japanese Medical Device Nomenclature 窶 Based on GMDN 2003 GMDN. However an ISO-13485 certificate will help you a lot when it comes to demonstrating that the Japanese quality management J-QMS requirements have been met.

The PMD Act provides the legal framework for the regulation of medical devices in vitro diagnostic reagents pharmaceuticals drugs and cosmetic products as well as regenerative and cellular therapy products in the Japanese market. In Japan pharmaceuticals and medical devices are regulated by the Pharmaceutical and Medical Device Agency PMDA and the Ministry of Health Labor and Welfare MHLW. The distribution of medical devices in Japan is regulated in accordance with the Pharmaceutical and Medical Device Act PMD Act Regulation by the Ministry of Health Labour and Welfare MHLW.

This file contains information concerning pharmaceutical administration regulations and new drug development in Japan updated annually by the. The former Regulation Japanese Pharmaceutical Affairs Law JPAL was replaced by PMD Act on November 25 2014. Current Japan PMDA regulations are laid out in the Pharmaceuticals and Medical Devices Act PMD Act also known as the Act on Securing Quality Efficacy and Safety of Pharmaceuticals Medical Devices Regenerative and Cellular Therapy Products Gene Therapy Products and Cosmetics.

42 Drug and Medical Device Safety Information Reporting System by Medical Personnel. Ministry of Health Labor and Welfare MHLW The MHLW is Japans primary regulatory body for creating and implementing safety standards for medical devices and drugs. The term medical device as used in this Law refers to medical appliances or instruments excluding regenerative medicine products intended for use in the diagnosis treatment or prevention of disease in humans or animals or intended to affect the structure and functions of the bodies of humans or animals as specified by Cabinet Order.

For medical devices manufactured imported andor sold in Japan Japanese Medical Device Nomenclature JMDN codes and generic names are set with reference to the medical device names determined in the ISOTC210 GMDN project. The PMDA is an independent agency that works together with the MHLW to assess the safety and effectiveness of medical products. In addition to this dossier a Quality Management System QMS and Foreign Manufacturer Accreditation FMA are required.

Within the MHLW the Pharmaceutical and Food Safety Bureau is in charge of pharmaceutical and medical device regulatory policy. Shin-Kasumigaseki Building 3-3-2 Kasumigaseki Chiyoda-ku Tokyo 100-0013 Japan. Then generic names are classified to Class I II III or IV according to their risk level.

Shin-Kasumigaseki Building 3-3-2 Kasumigaseki Chiyoda-ku Tokyo 100-0013 Japan. 169 on quality management systems. Regulations in Japan.

The regulatory authority in Japan is the Pharmaceuticals and Medical Devices Agency PMDA.