In spite of Japan's substantial population and strong economy, the regulatory process has long been considered arduous and cumbersome by those in the medical device industry, and it in fact serves as a primary deterrent to market entry there. So far as regulatory systems go, Japan's seems akin to pulling teeth. In the generally high growth spinal nonfusion technology market segment for instance, only one product, Medtronic's X-STOP, has satisfied the requisite criteria to attain regulatory clearance from the Japanese Ministry of Health, Labour and Welfare's (MHLW) Medical Device Evaluation office up to August 2014. Among established economies, this can be considered to be a true anomaly.
However, announcements pertaining to policy amendments and regulatory reform seem to have offered real hope that the tide in Japan might be shifting, potentially causing a few medical device manufacturers to rethink their investment strategy there. The appeal to foreign manufactures would experience a definite and tangible uptick should these reformations take hold. The MHLW has shed light on some of the planned changes including amendments to the Pharmaceutical Affairs Law (PAL). Critically, these changes include plans to expand dependency on third-party certification, rather than governmental certification, to include some Class III devices. To date, this has only been done for Class II devices. This measure is anticipated to allow for the implementation standard periods for the Pharmaceutical Medical Device Agency's (PMDA) application evaluations, expected to be implemented by 2018.
The MHLW has also indicated their intention to enforce new software requirements related to medical device processing and data storage. Other critical changes include the shift of manufacturer licensing and accrediting system for foreign facilities to a registration system and the elimination of the perfect-level system inspection requirements. These steps are geared towards streamlining the approval process and lower the threshold of requirements without tangibly affecting quality control or compromising standards. There are also intentions to introduce a regenerative product category for those categories not easily categorized as a drug or a medical device; a move indicative of the modern new approach.
The MHLW anticipates initiation of these changes to begin in November 2014. The largely stable Japanese medical device competitive landscape stands to experience some dynamism in the years to come, as these changes aid in partially easing the process for device registration and commercialization for many multi-national corporations. Competitive pricing might yet increase in the nation. Let the intrigue begin.