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Medical Devices Regulatory Services in Japan
Your regulatory partner for MedTech services in Japan, from concept to market.
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
Tailored regulatory solutions for PMDA compliance
Experienced professionals' assistance in accurate device classification
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
Ensuring compliance for 200+ Devices and Diagnostics Products Licenses
KPI based, continual process excellence
Wide Therapeutic Areas, Formulation and Route of Administration Experience
Customer focused timely compliance with PMDA guidelines
ISO 9001:2015, Quality Driven Services Platform
Flexible Business Models – Project Based; Long Term FTE based
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
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
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