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Medical Devices Regulatory Services in Japan
Artixio helps you meet PMDA requirements with end-to-end regulatory support for medical devices in Japan.
Artixio provides seamless regulatory services for commercialization of your medical device in the Japanese market. Our experienced professionals in Japan help you streamline the regulatory journey for your MedTech product. We assure timely compliance with the stringent guidelines the PMDA. Our dedicated team provides assistance right from product conceptualization till product surveillance.
Key Regulations for Medical Devices in Japan
- Pharmaceuticals and Medical Devices Act (PMD Act
- GMP (Good Manufacturing Practice
- Foreign Manufacturer Accreditation (FMA):
- Device Classification System
- Shonin and Ninsho Approvals
Artixio’s Medical Devices Registration Services in Japan
Our Regulatory and Market Access experts based in Japan, coupled with the global Regulatory projects team, have assisted over a hundred pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements, and veterinary products successfully register and maintain compliance with the PMDA in Japan. Artixio’s local experts are committed to assist you register and launch your device medical device in Japan. Coupled with the Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers around the globe have benefited by seamlessly managing the regulatory strategy for the product development and commercialization value chain.
For Medical Devices, from strategic planning and registration to post-market compliance, Artixio provides high-quality efficient regulatory affairs services to support your business in Mexico.
Why Artixio as your Medical device consultant in Japan?
We understand the complexities of PMDA pathways and guide you through every step.
Work with professionals who know Japan’s regulatory culture, not just the rules.
Local experienced staff with 15-35+ years of experience in Japan
Regulatory intelligence driven solutions for device compliance
End to End Support from Product Conceptualization to Launch and Post Market Support
Support with Japan-specific QMS audits — no surprises, just smooth compliance.
KPI based, continual process excellence
Wide Therapeutic Areas, Formulation and Route of Administration Experience
We manage your pre-market approvals and stay with you for post-market vigilance.
Our local and global teams stay responsive, so your timelines don’t suffer.
FAQs
What is the Shonin process?
Shonin process is the approval process for the class III and class IV medical device that involves full PMDA review process.
What is D-MAH?
A D-MAH allows the foreign manufacturer to own a product ownership but have a Japanese company handle its regulatory duties.
Do medical devices sold in Japan should need product label in Japanese?
Yes, all the medical devices sold in Japan should include Japanese label.
How much time is required for medical device approval in Japan?
The approval period of medical devices in Japan depends upon the class of the device such as class I device requires few days; class II device requires 4-6 months whereas class III devices take 9-18 months.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
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Europe
Malaysia
Taiwan
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Thailand
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