Many medical device manufacturers are seeking to promote their products in Japan, a decision which can be very rewarding but poses its own challenges
While Japan accepts testing according to ISO 10993, there are some unique requirements in Japanese medical device regulations that may be more sensitive and challenging, with concepts being similar and methods being different.
To market a device in Japan, it is very likely that the Ministry of Health Labor and Welfare (MOHLW) will insist on testing conducted according to their specifications.
MET in partnership with Namsa now provide comprehensive testing to MOHLW biocompatibility testing protocols, including exaggerated extraction methods, colony assay cytotoxicity, MHLW sensitisation, MHLW irritation and MLHW geneotoxicity.
Japanese ministry regulations require testing and reporting to these specific protocols and Namsa have validated studies to allow testing to a wide variety of specific Japanese requirements.
Reports are compiled by native Japanese speakers, ensuring rapid progress through the regulatory system.
In addition, MET also has the capability to conduct tests according to Japanese Pharmacopoeia.
