program medical equipment
Updated: July 2024, 9
Due to the revision of the Pharmaceutical Affairs Law in 26, the program itself is now included in the scope of medical devices.
Before the revision, the medical device hardware in which the program was installed was itself considered a medical device, but programs that are not tied to specific hardware and are versatile must be registered as medical devices in their own right. It won't.
Support Administrative Scrivener Corporation supports registration applications for program medical devices.
Scope of programs applicable to medical devices
Programs are broadly divided into three programs and the recording medium that records the three programs.
| CAD | Common name example (class) |
| Disease diagnosis program Recording medium that records disease diagnosis programs | Program for general-purpose X-ray diagnostic equipment (class II) Program for mammography combination X-ray diagnostic equipment (Class II) Program for urinary and gynecological X-ray fluoroscopy diagnostic equipment (class II) Program for dental panoramic X-ray diagnostic equipment (class II) Program for positron CT device for nuclear medicine diagnosis (class II) Electronic blood pressure monitor program (class II) Program for ultrasound equipment workstation (class II) |
| Disease treatment programs Recording medium that records disease treatment programs | Treatment planning program for peritoneal dialysis (class III) Treatment planning support program for dental implants (class II) Orthodontic treatment support program (class II) External fixator treatment planning support program (Class II) |
| Disease prevention programs Recording media that records disease prevention programs |
Even in the event of side effects or functional impairment, programs that have little risk of affecting human life or health, and the recording media that record them, are excluded from the scope of programs as medical devices.
Manufacturing and sales of programmed medical devices
Regarding programmed medical devices, the set classifications are Class II, III, and IV, so the corresponding manufacturing and sales licenses are Type 1 medical device manufacturing and sales business license, Type 2 medical device manufacturing and sales business license. You will need to obtain a sales license.
The licensing requirements are the same as for other medical devices.
Programmed medical device manufacturing industry
Regarding the manufacturing industry of program medical devices, unlike other medical devices, factories whose processes are circled in the table below will be certified.
| Design | Main assembly | sterile | in Japan Storage of final products | |
| medical device program | ○ | × | × | × |
| Recording medium that records medical device programs | ○ | × | × | ○ |
In addition, for manufacturers that only do design, the requirements for the responsible engineer are relaxed, and no academic background or experience is required, and the position can only be filled by "a person designated by the manufacturer as the person in charge of the department related to design." I can.
Programmed medical equipment sales business
To sell programmed medical devices, sales procedures are required, just like other medical devices.
| Class ⅢⅣ | Class II | |
| medical device program | If provision is made through telecommunications lines, a highly controlled medical device sales business license is required. | If provision is made through telecommunications lines, a controlled medical device sales business notification is required. |
| Recording medium that records medical device programs | Highly controlled medical device sales business license required | Managed medical device sales business notification required |
Notices related to medical device programs
For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors.
Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.
We provide legal services related to medical devices based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.
Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
Our dedicated staff handles cases nationwide.
