Medical Device Registration In Japan Overview
Japan is the second biggest market for Medical devices and is expected to reach US $74.4 billion by 2025. Key factors driving growth for medical device registration in Japan are:
- Population increasingly skewed toward geriatrics
- Increase in life-style diseases and chronic health conditions
- A wider population base being covered under universal health insurance
- Regulatory changes to facilitate innovative technologies
Though the market looks promising, the major barrier in obtaining medical device approval in Japan market is the stringent Pharmaceuticals and Medical Devices Agency (PMDA) regulations that companies must abide by. To manage their product registrations and liaise with Japan’s regulatory authorities, all foreign medical device and pharmaceutical companies selling in Japan must assign a Japan DMAH agent.
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