Understanding Japan’s Clinical Data Requirements

Japan’s Pharmaceutical and Medical Devices Act

Japan’s Pharmaceutical and Medical Devices (PMD Act) is the cornerstone of medical device regulation, product safety and efficacy before market entry. Understanding its requirements is critical for manufacturers aiming to introduce medical devices in Japan.

The Japan Medical Device Nomenclature (JMDN) system categorizes devices similarly to the FDA’s product codes. Each JMDN code corresponds to a specific device type, risk classification and the appropriate registration route. Once a device’s JMDN is identified, manufacturers can determine whether they need PMA, PMC or PMN.

Why compliance with the PMD Act matters

Successfully navigating Japan’s regulatory landscape facilitates compliance, accelerates market entry and prevents costly delays. This white paper provides a breakdown of Japan’s PMD Act and a detailed explanation of PMA, PMC and PMN routes. Once again, The PMDA determines whether clinical data is required for a medical device premarket authorization depending on the manufacturer’s non-clinical data and equivalence with like devices.

The PMD Act requires clinical data for some devices subject to the PMA route. Unlike U.S. Food and Drug Administration (FDA) Pre-Market Approval and European CE marking certification, PMAs in Japan do not always require clinical data. Also, PMN and PMC routes do not require clinical data.

The Ministry of Health and Welfare (MHLW) issued the notice for Guidance for the scope of medical devices requiring clinical data (Yakushokukihatsu No. 0804001), dated August 4, 2009. The MHLW notice mentions that clinical data is required if a medical device’s clinical effectiveness and safety cannot be demonstrated only by non-clinical data, such as non-clinical performance and safety tests, including animal tests, bench tests or existing literature.

The MHLW notice also mentions that the PMDA comprehensively determines whether clinical data is required for a medical device PMA depending upon the manufacturer’s existing non-clinical data and equivalence with similar devices. In addition, the MHLW notice recommends that manufacturers request a PMDA Pre-submission consultation to seek the PMDA’s determination of whether clinical data is required.