As previously reported in our Asia Medical eNewsletter, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is working on overhauling its medical device approval process in order to reduce long review times. Part of this medical device regulation change calls for increasing the PMDA’s medical device reviewers from the 35 now to 104 by 2013. To help pay for this expansion, the government fees for reviewing medical device applications (“Shonin” applications) are set to rise significantly starting April 1, 2009.
According to the PMDA plan, which is currently being circulated, not only will fees go up, but more categories will also be added so that the fee structure is more similar to structures in other countries. In the current system, medical device review fees are determined by two factors: (a) whether the application is supported with clinical trial data, and (b) whether the device conforms to the government’s Technical Standards for its type. However, under the new system, fees will also vary based on whether the device is Class II, Class III, or Class IV, as well as whether it is novel, improved, or “me-too.”
It should be noted that this fee increase does not apply to Class I devices, for which only notification is required. It also does not apply when a Class II device is submitted to a third party (similar to a Notified Body) for “Ninsho” approval. In that case, the third party sets the fee independently.
The planned review fee increases are substantial. Previously, the lowest possible fee for a new device was Â¥386,700 (about US$3,923), for a Class II device that both conformed to Technical Standards and did not require clinical trials. Now, the fee for the same device will be Â¥445,900 (about US$4,524). Fees for devices that do not match Technical Standards were previously Â¥1,286,100 (about US$12,866), and will now range from Â¥1,511,700 (about US$15,338) to Â¥2,457,200 (about US$24,931) depending on their classification and degree of novelty.
The steepest rise in fees will be for new devices that are supported with clinical trial data. Previously, such applications cost Â¥3,849,000 to review (about US$39,052). Now, the cost will range from Â¥4,485,700 (about US$45,512) to as much as Â¥9,470,000 (about US$96,084), again based on the classification and degree of novelty.