Once a company registers its medical device product in Japan, there is often a question of whether to register its new or upgraded products as partial amendments to its existing Shonin or under a new me-too product application. According to the Ministry of Health, Labor, and Welfare (MHLW), a new application is required for each case of a change in type. The term, change in type can be better understood as a change in model. The following examples are considered changes in type by the MHLW:
- Addition of a new function
- Change in the series of catalog numbers (i.e. 4000 Series vs. 4200 Series)
- A significant change in name (i.e. Scanner C400 vs. VF2000)
- Difference in appearance
The following are not considered changes in type:
- The same function and effects
- Changes in catalog numbers are restricted to sub-numbers (i.e. No. 3000-01 vs. No. 3000-02)
- The apparatus has the same basic name and has a different sub-name (i.e. Heart Monitor 2000-A1 vs. Heart Monitor 2000-A2)
- The change is a result of deletion or simplification of a product’s functions
Oftentimes, a foreign medical device manufacturer changes a product name for marketing purposes without realizing that this results in the requirement of a new Shonin (product registration) application. Thus, companies must be cautious in their marketing decisions for they may have regulatory implications in Japan.
If the new or upgraded product is determined to be a change in type from the previous product, the company must apply for a new me-too product Shonin. If no change is determined, the product can be registered as a partial amendment to the original Shonin. In their official statements, the Japan Association for the Advancement of Medical Equipment (JAAME) estimates that the evaluation time for a partial change application is two months, and for a me-too device application, it is approximately four months. However, in reality, the review time is longer (about 6 months) for both types of applications and the time-to-approval is about the same.