Japan's medical industry is undergoing significant restructuring with respect to the regulation of medical devices. The Ministry of Health and Welfare, the country's formal medical device administration recently initiated a series of directives that will transform and establish Japan as one of the world's most stringently regulated markets. The Ministry was spurred by a series of incidents across a broad range of industries that compromised the safety of consumers. These mishaps led to the implementation in March 2000 of Ordinance Number 237 which out-lines revised recall procedures for medical devices. The ordinance stipulates an immediate and compulsory recall for that batch of medical device found adulterated with a foreign object matter; it is very similar to the equivalent FDA guideline.
Furthermore, the Good Manufacturing Practice (GMP-I) regulations for the importation of medical devices were also amended. Wholesalers or distributors in Japan are now considered as the official sponsors of an imported medical device. Basically the wholesaler or distributor is now liable for any incident pertaining to an imported medical product although the distributor or wholesaler will turn to the actual manufacturer for final responsibility.
A contentious issue has been the somewhat lax regulation of examination gloves. Examination gloves, unlike surgical gloves, are not categorized as medical devices and as such are considered to be of inferior quality (and hence unacceptable) by other developed markets that have flooded the Japanese medical market. The focus has been on gloves manufactured from polyvinyl chloride (PVC). Although PVC gloves are predominantly used in the healthcare setting the material is considered in many studies to be inferior to latex. Recent public furor arose over conceivable health risks posed by PVC through the emission of toxic by-products from incomplete incineration and the leaching of other harmful residues onto food during handling. The latter raised such serious concerns that PVC gloves were recently banned from any food handling.1 Some restaurants even displayed signs advertising that no PVC gloves were used on the premises.
A series of revised surgical and dental glove standards presided over by the Japan Industrial Standards (JIS) were ratified in May 2000 with manufacturers and sponsors allocated twelve months to comply. The premise is for alignment and harmonization with ISO 10282 and ISO 11193 for surgical and examination gloves (latex and PVC) respectively. New JIS standards for examination gloves were also implemented. Despite examination gloves now complying with these international standards, the Ministry of Health and Welfare still does not class these products as medical devices. However, this position is currently under review.
Inventory management is also a key agenda. In efforts to rationalize inventory holdings and reduce the amount of overall inventory on hand while concurrently delivering more capital to fund other areas of the health sector, guidelines for bar coding of medical devices were introduced in October 1999. The system selected was EAN-128. Although not mandatory, the recommended bar coding guidelines are being increasingly adopted by medical institutions countrywide thus obliging many manufacturers and suppliers to incorporate bar coding on products. Presently only multi-unit packaging incorporates the bar coding. However there has been some indication that it will be extended to unit packaging.
The Japanese medical industry is certainly in the throes of transformation. After years of stagnation, new and amended regulatory initiatives imposed by the government will ensure that the well being of citizens
and healthcare professionals remains its primary objective.
REFERENCES
- Usage of PVC gloves for food (handling), JPN MHW Enviromental Health Bureau, Food Chemistry Manager, Eika-No. 31, 2000.
