Japan is the third-largest medical device market in the world, so it warrants important attention by medtech companies planning their global commercial strategy for new products. But for foreign device firms the country is not an easy one in which to make inroads.
The regulatory authorization process has long been viewed as opaque and challenging for outsiders, although the government has taken steps in recent years to improve predictability and engagement.
For reimbursement, the narrative is different. Many companies have an outdated understanding of Japan’s reimbursement realities, which have become more challenging over the past decade or so, explains Ames Gross, founder and president of Pacific Bridge Medical, an Asia medtech market access consultancy. As a result, he says, despite Japan’s large market size, manufacturers too often enter the market without a clear path to profit.
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