Japan is renowned for its advanced healthcare system and rigorous standards in medical device regulation. The country’s approach ensures that medical devices are safe, effective, and of high quality. If you're navigating the Japanese medical device market, understanding the regulatory landscape is crucial. Here’s a comprehensive guide to the regulation of medical devices in Japan.
PMDA Regulation of Medical Devices in Japan
The primary regulatory body responsible for regulation of medical devices in Japan is the Pharmaceuticals and Medical Devices Agency (PMDA). The PMDA operates under the Ministry of Health, Labour and Welfare (MHLW) and plays a pivotal role in ensuring the safety, efficacy, and quality of medical devices. The MHLW oversees the overall regulatory framework, while the PMDA handles technical reviews of product applications and approvals as well as monitoring post-market safety and effectiveness. The Pharmaceutical and Medical Device Law (PMDL), previously known as the Pharmaceutical Affairs Law (J-PAL), is the key legislation governing the regulation of medical devices and pharmaceuticals in Japan.
PMDA Medical Device Classification in Japan
In Japan, medical devices are categorized into four classes according to the level of risk they pose to individuals. The registration requirements differ depending on the device’s classification, as determined by JMDN Codes:
Class I: Extremely low-risk devices, such as scalpels and X-ray films.
Class II: Low-risk devices, including ultrasonic devices.
Class III: Medium-risk devices, such as dialysis machines.
Class IV: High-risk devices, such as pacemakers and stent grafts.
PMDA Medical Device Registration Pathways in Japan
Medical device registration in Japan involves several pathways, each depending on the device's classification:
Class I Devices: These require a pre-market submission (Todokede) to the PMDA. They are exempt from Quality Management System (QMS) requirements and PMDA review. Registration usually takes about one week, with no associated PMDA fees.
Class II Devices:
With JIS Standards: Requires pre-market certification (Ninsho) through a Registered Certification Body (RCB). The review process typically takes 3 to 5 months.
Without JIS Standards: Requires approval from the MHLW.
Class III Devices:
With JIS Standards: Certification through an RCB.
Without JIS Standards: Requires MHLW approval.
Class IV Devices: All Class IV devices require Pre-Market Approval (Shonin) from the MHLW.
PMDA QMS Requirements for Medical Devices in Japan
Manufacturers must comply with QMS requirements as defined under Ordinance No. 169. . In Japan, the Medical Device Single Audit Program (MDSAP) program is aligned with the requirements set forth by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). A successful MDSAP audit satisfies the QMS requirements for Japan, reducing the need for separate, country-specific audits.
PMDA Labeling Requirements for Medical Devices in Japan
Medical device labeling in Japan must comply with Article 52 of the PMD Act. Labels must be in Japanese and include detailed instructions for use. For Class IV devices, a package insert notification system is in place.
PMDA Foreign Manufacturer Registration (FMR) of Medical Device Facilities in Japan
Foreign manufacturers must register their facilities through the FMR process. Facilities involved in the design, development, manufacturing, or sterilization of medical devices must be registered. The FMR certificate is valid for five years, and renewal procedures should begin at least five months before expiration.
PMDA Local Representative Requirements for Medical Devices in Japan
Foreign manufacturers must appoint an Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH) in Japan to handle device registration and market entry. The MAH or DMAH must be located in Japan. The MAH or DMAH is responsible for:
Managing the device approval process.
Ensuring product safety and quality.
Overseeing post-market surveillance.
Manufacturers can choose to establish a local subsidiary, use a distributor as MAH, or appoint an independent third-party service provider.
Medical Device Registration Processes in Japan
Shonin (Pre-Market Approval) : The Shonin pathway is used for Class II, III, and IV devices. It requires -
Submission of general device data, including clinical data and efficacy risk analysis.
Provision of documentation in Japanese.
Appointment of an MAH or DMAH and obtaining a Foreign Manufacturer Registration (FMR) certificate.
Compliance with QMS requirements, including a detailed QMS audit by the PMDA.
The approval process typically takes 9 to 16 months, depending on the device classification and whether JIS standards apply.
Ninsho (Pre-Market Certification) : Ninsho is applicable for Class II and some Class III devices that meet JIS standards. It involves:
Selecting a Registered Certification Body (RCB).
Submitting documentation and undergoing a QMS audit by the RCB.
The certification process generally takes 3 to 5 months.
Todokede (Pre-Market Submission) : Todokede is used for Class I devices and allows for self-certification without PMDA review. The process is relatively quick, usually taking less than one month, and does not require QMS documentation for most Class I devices.
Japan presents a promising market for medical device manufacturers but comes with intricate regulatory requirements. Understanding the classification, registration pathways, and requirements for QMS, labeling, and local representation is essential for successful market entry. Engaging with a reliable regulatory partner can streamline the process and help navigate the complexities of the Japanese medical device regulatory landscape.
Artixio: Your Partner in Medical Device Regulation
Navigating Japan’s regulatory landscape can be complex and time-consuming. This is where Artixio steps in as a valuable partner. ARtixio specializes in providing comprehensive regulatory support for medical device manufacturers looking to enter the Japanese market. Their services include:
Regulatory Strategy and Consulting
Registration and Certification
Quality Management System (QMS) Compliance
Labeling and Documentation
Foreign Manufacturer Registration (FMR):
Market Authorization Holder (MAH) Services
Get in Touch Today
Reach out to Artixio for expert assistance with your medical device regulatory needs. Our team of professionals is ready to provide tailored solutions to ensure your success in the Japanese market and beyond.
Contact Us at:info@artixio.com
Let Artixio guide you through every step of your regulatory journey with confidence. We look forward to helping you achieve your goals.
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