(1) Revision of PAL
The medical device industry, including JIRA, desired the revision of PAL for many years. It was finally revised by an extraordinary Diet session and enacted on November 20 and promulgated on 27, 2013. (A new law was named “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics”.) We had submitted our proposals based on the characteristics of the JIRA’s product through Japan Federation of Medical Devices Association (JFMDA) so that the new law might include them. As a result of this activity, stand-alone software programs are defined as a medical device, a succession system of certified products is introduced, the third party certification is expanded to specially controlled medical devices , and the Quality Management System (QMS) inspection is rationalized.
(Regulation and Safety Division)
(2) Revision of the reimbursement of medical treatment fees in 2014
The activity of Economy Division is based on three major concepts, "safety auurance", "technical weighted assurance" and “diagnostic purpose weighted assureance". Based on these concepts, we worked continuously. Under the concept of security, we attempted to increase payment for maintenance of “specially designated maintenance management required medical devices”. Under the concept of management guarantee, in the 2014 revision, payment increased for a 64-row CT, but decreased greatly for a 16-row or less. The payment decreased greatly for a 16-row through 64-row large intestine CT. Under the concept of accuracy guarantee, in the 2014 revision, real-time computerization was required for positional relation between 3D images and the operation field.
(Economy Division)
(3) Radiation dose
In order to make the Radiation medical equipment and related devices can contribute to medical care, we clarified our policy aimed at radiation and dose control, reduction of the dose. The excessive dose during X-ray CT perfusion imaging spurred U.S. Food and Drug Agency to pay attention to high-dose diagnostic X-ray equipment [X-ray CT, X-ray fluoroscopy, including interventional radiography (IVR)]. We continued to make efforts to solve the problem.
(Radiation & Dose Committee)
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