PMDA Japan Medical Device Registration & Approval
Japan's position as the world’s second-largest medical device market, with a population of over 123 million and approximately 35% of medical devices imported, presents significant opportunities for global manufacturers. The country's advanced healthcare system and regulatory environment offer a fertile ground for high-quality medical devices seeking PMDA medical device registration.
Understanding Regulatory Classifications in Japan
Regulatory Authority
Medical devices sold in Japan are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labor, and Welfare (MHLW). Pure Global can assist with Japan medical device registration and act as your Designated Marketing Authorization Holder (DMAH), ensuring PMDA approval to sell in the Japanese market.
Classification
Devices are categorized into classes I through IV, reflecting increasing risk levels. This classification dictates the regulatory requirements, from pre-market notification for class I devices to certification or approval processes for higher-class devices.
Key Requirements
Foreign manufacturers must navigate Japan’s regulatory landscape by:
- Appointing a Japan-based Designated Marketing Authorization Holder (DMAH) if there is a lack of business presence in Japan.
- Ensuring compliance with Japan's Quality Management System (QMS) regulations.
- Following the appropriate pre-market certification or approval pathway based on the device's classification.
Tailored Support for Market Entry
Leverage our expertise to enter or expand your presence in the Japanese market:
Guidance on classifying your products and determining the appropriate regulatory pathway.
Assistance with compiling the necessary technical dossier for PMDA submission.
Representation as your Designated Marketing Authorization Holder (DMAH) , managing the registration process and ensuring post-market compliance.
Frequently
Asked Questions
What is the regulatory authority for medical device registration in Japan?
The Japan Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority responsible for the registration and approval of medical devices in Japan. They oversee the compliance and regulatory requirements for market access.
How are medical devices classified in Japan?
Medical devices in Japan are classified into four classes (I to IV) based on their risk level. The medical device classification in Japan dictates that Class I devices have the lowest risk and typically require pre-market notification, while higher-risk devices (Class II to IV) require more stringent certification or approval processes.
What are the key requirements for foreign manufacturers to market medical devices in Japan?
Foreign manufacturers must appoint a Japan-based Medical Device Handler (MDH) or Medical Device Authorized Representative (MDAR) if they do not have a business presence in Japan. Additionally, manufacturers must ensure compliance with Japan medical device regulations, including Japan's Quality Management System (QMS) regulations, and follow the appropriate pre-market certification or approval pathway based on the device's classification.
What is the role of the Quality Management System (QMS) in Japan's medical device registration process?
Compliance with Japan's Quality Management System (QMS) regulations is essential for medical device registration. The QMS ensures that manufacturers maintain high standards in their production processes, which is a critical component of the certification or Japan medical device approval process.
We Provide Access To 28+ Markets Worldwide
Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.