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.