![]() The MAH assumes liability for your devices in Japan and is the owner of the authorization. Step 2: Establish the necessary roles Marketing Authorization Holder (MAH)Īs the next step, as the manufacturer, you have to appoint a local authorized representative, known as the Marketing Authorization Holder (MAH). These include requirements for retention periods and vigilance, and rules for communication between the manufacturer and authorized representative. However, Chapter 3 contains additional requirements that you, as the manufacturer, and your authorized representative (MAH) must comply with. MO 169 is essentially harmonized with ISO 13485:2003 ( comparison table, section 2). The quality management system requirements can be found in Ministerial Ordinance No. 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. “Administrative Notices” are equivalent to MDCG and FDA guidances and are not legally binding.ī) 8 steps to authorization Step 1: Establish a QM systemĪs a foreign manufacturer, you do not have to demonstrate “home country approval” to have a medical device authorized in Japan. In the hierarchy of regulations, the PMD Act is followed first by “Cabinet Ordinances”, then “Ministerial Ordinances/Notifications” and lastly “Administrative Notices.” These regulations are relevant to the authorization of medical devices in Japan. The PMD Act includes requirements for the marketing, quality assurance and guaranteeing the efficacy and safety of medicinal products, medical devices, regenerative medicine products, cellular therapies, gene therapies and cosmetics. It replaced the Pharmaceutical Affairs Law (PAL). Since 2014, the Pharmaceutical and Medical Device Act (PMD Act) has been the most important law. ![]() Inspections of manufacturers for compliance with Good Manufacturing Practices (GMP).Providing advice on clinical studies and authorizations being targeted.Conducting the authorization procedures, including the regulatory review.The PMDA, which was created in 2004, is responsible for the actual tasks within the authorization procedures for medicinal products, medical devices and regenerative medicine products for the Japanese market. The final release of medical device authorizations.Enacting ministerial ordinances, guidelines and industry standards. ![]() Licensing certain actors (MAH, dealers and repair service providers).With regard to the regulation of medical devices, the MHLW's tasks include: The mission of the MHLW is to protect the population of Japan against health hazards caused by pharmaceutical products and medical devices that are not sufficiently safe or effective or not of sufficiently high quality. It is subordinate to the Ministry of Health, Labour and Welfare (MHLW). The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory authority. A) Regulatory framework for authorization 1.
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