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Este informe proporciona un análisis profundo del mercado de dispositivos médicos en Japón, incluyendo pronósticos de mercado a 5 años, datos nacionales, información sobre tendencias de salud,
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How to fill out The Medical Device Market: Japan

01
Begin by researching the current landscape of the medical device market in Japan.
02
Identify the regulatory requirements for medical devices in Japan, including compliance with the Pharmaceutical and Medical Device Agency (PMDA).
03
Gather data on key players and competitors in the market.
04
Analyze consumer needs and preferences related to medical devices.
05
Study market trends and technological advancements in the Japanese medical device sector.
06
Compile statistical data on market size, growth projections, and segment analysis.
07
Prepare a comprehensive report detailing your findings and insights.

Who needs The Medical Device Market: Japan?

01
Medical device manufacturers looking to enter or expand in the Japanese market.
02
Investors seeking opportunities in the medical device sector in Japan.
03
Healthcare professionals and institutions aiming to understand market dynamics and product availability.
04
Regulatory bodies and policymakers interested in market assessments and trends.
05
Market analysts and consultants providing insights to clients in the healthcare industry.
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Japan's Ministry of Health, Labour and Welfare (“MHLW”) data show that the Japanese market for medical devices in 2021 totaled $40 billion. Fitch Solutions estimates that Japan's medical device market will exhibit a compound annual growth rate (“CAGR”) of 5.5 percent from 2022 to 2027.
The medical technology (MedTech) sector is rapidly growing in Japan. Driven by an aging population, increasing demand for healthcare innovation, and the integration of digital solutions into medical services.
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Japan's Ministry of Health, Labour and Welfare (“MHLW”) data show that the Japanese market for medical devices in 2021 totaled $40 billion. Fitch Solutions estimates that Japan's medical device market will exhibit a compound annual growth rate (“CAGR”) of 5.5 percent from 2022 to 2027.
Appoint a Marketing Authorization Holder (MAH) or a Designated MAH (DMAH) who will manage the device registration in Japan. Low-risk devices require a MAH, while all other device classes may use a DMAH. Foreign manufacturers must submit a Foreign Manufacturer Establishment Registration (FMER) application to the PMDA.

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The Medical Device Market in Japan refers to the regulatory framework and market dynamics for medical devices within Japan, which is one of the largest markets for medical devices globally. It encompasses the production, import, distribution, and use of medical devices that are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Manufacturers, importers, and distributors of medical devices that are sold in Japan are required to file with the Medical Device Market in Japan. This includes both domestic companies and foreign entities seeking to market their devices in the Japanese market.
To fill out The Medical Device Market filing, entities must prepare and submit the necessary documentation, which includes product specifications, safety and efficacy data, quality control measures, and compliance with Japanese regulations. This typically involves submitting an application to the PMDA along with all required supporting documents.
The purpose of The Medical Device Market in Japan is to ensure the safety and efficacy of medical devices available in the market, protect public health, and facilitate access to innovative medical technology while maintaining regulatory standards.
Reported information typically includes device identification, classification details, clinical data, manufacturing and quality assurance processes, labeling information, post-market surveillance plans, and any adverse event reporting commitments.
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