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Japan - Regulation

The Reorganization and Rationalization Plan for Special Public Corporations that was approved in a Cabinet meeting in 2001, was followed by the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA) and came into service on April 1, 2004, under the Law for the Pharmaceuticals and Medical Devices Agency, as a consolidation of the services of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and part of the Japan Association for the Advancement of Medical Equipment (JAAME). The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory authority. It is subordinate to the Ministry of Health, Labour and Welfare (MHLW). 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 

With regard to the regulation of medical devices, the MHLW's tasks include: 

  • Registering manufacturers 

  • Licensing certain actors (MAH, dealers and repair service providers) 

  • Enacting ministerial ordinances, guidelines and industry standards 

  • The final release of medical device authorizations 

  • Monitoring the PMDA 

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 PMDA’s most important tasks include: 

  • Conducting the authorization procedures, including the regulatory review 

  • Providing advice on clinical studies and authorizations being targeted 

  • Inspections of manufacturers for compliance with Good Manufacturing Practices (GMP) 

  • Market surveillance. 

Step 1: Establish a QM system 

As a foreign manufacturer, you do not have to demonstrate “home country approval” to have a medical device authorized in Japan. 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.

Step 2: Establish the necessary roles 

Marketing Authorization Holder (MAH) 

As the next step, as the manufacturer, you have to appoint a local authorized representative, known as the Marketing Authorization Holder (MAH). The MAH assumes liability for your devices in Japan and is the owner of the authorization. Not every citizen is allowed to be an MAH. The MAH must first apply for a license (business license known as KYOKA) from the MHLW.

Step 3: Register as a manufacturer 

Before having your medical device authorized in Japan, you must, with the help of the marketing authorization holder (MAH), register as a foreign manufacturer with the Ministry of Health, Labour and Welfare (MHLW). All manufacturing sites responsible for development and final assembly or production must be registered. Component manufacturers do not have to register. 

  • Information on the person responsible for regulatory compliance 

  • Information on the production site

Step 4: Classify the medical device 

The PMD Act differentiates between three types of medical device: general, controlled and specially-controlled medical devices. These are divided into four classes: I (low risk), II, III, IV (high risk).

Medical device companies interested in offering their products in Japan must comply with Japan's Pharmaceuticals and Medical Devices Act (PMD Act). Complying with the PMD Act can be challenging for foreign manufacturers, as very few regulatory documents are published in English. As part of the approval process, medical device manufacturers must: 

  • Comply with MHLW Ordinance No. 169 related to quality management systems 

  • Appoint an in-country representative (MAH/D-MAH) 

  • Register design and manufacturing facilities, among other requirements 

Device Category 

Process Undergone 

Timeline Validity 

Cost (Fee structure) 

Low Risk Medical Devices 

These are subjected to Pre-Market submission (PMS), also known as ‘Todokede’. Applications submitted to the PMDA & considered accepted upon submission. 

It takes one week to get the PMS number. 

There is no PMDA fees to process the application 

Most medium Risk Class II & Few High Risk Class III 

 

 

Qualify for Pre-Market Certification (‘Ninsho’). 

Reviewing & Quality system conformity assessments are outsourced by PMDA to Registered Certification Bodies (RCB) 

Average time taken for PMC processing is 3 months 

US $30,000 

New Class II, Class III & Class IV devices 

Subjected to Pre-Market Approval (‘Shonin’).  

Time for processing application varies from 6 months to 36 months. 

US $20,000 (6 months) & US $120,000 (36 months). 

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post submission support and technical liaison with authorities.

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