A. Prescribe applications for staged reviews of innovative medical devices, etc. (Article 3, Article 4)
- Prescribe special cases on authorizations/permits to allow applications for reviews in stages when applying for a permit/certification for an innovative medical device by stipulating procedures and methods for staged review applications, approvals/modified approvals, results notifications, etc., as delegated by the Act
B. Prescribe applications for prioritized reviews of innovative medical devices, etc. (Article 5)
- Improve provisions to allow medical devices that have been designated as innovative medical devices to take priority over other medical devices when conducting reviews, and thereby promote their development and commercialization
C. Prescribe procedures and methods for feasibility reviews of in-house standards and specifications (Article 6)
- Improve provisions to allow permits, etc., to be granted by applying standards and specifications proposed by a manufacturer in the event that there are no standards or specifications for manufacturing permits, etc., of innovative medical devices in accordance with Article 22, paragraph 6 of the Act
D. Prescribe post-marketing surveillance of innovative medical devices, etc. (Article 7)
- Prescribe procedures and methods, etc., delegated by the Act, Article 23 of which states that post-marketing surveillance may be carried out only where it is necessary to observe the clinical effects and monitor the adverse events of a medical device that has been designated as an innovative medical device
E. Application for innovative medical device software manufacturing firm certification (Article 8)
- Prescribe procedures and methods, etc., for applications for manufacturing firm certification as delegated by the Act, Article 24, paragraph 1 which prescribes special cases allowing software designated as innovative medical devices to obtain a manufacturing firm certification, and allowing the exemption of materials necessary for permits/certifications when applying for an authorization/permit
F. Prescribe the reporting of changes to innovative medical device software, etc. (Article 10)
- Prescribe procedures and methods for reporting changes and storage procedures for evidentiary materials on safety/efficacy, records, etc., in accordance with improvements to the system involving a switch to a negative method requiring changes other than those concerning serious matters to be reported, instead of obtaining a permit/certification under the Medical Devices Act or obtaining a change permit, etc., for registered matters
G. Prescribe good clinical practice standards for innovative medical device software (Article 11)
Prescribe clinical practice standards that are more lenient than those under the Medical Devices Act in the case of software for which clinical studies are conducted using existing patient information without contacting persons (subjects)
H. Prescribe facility, manufacturing, and quality control standards for manufacturers and importers of innovative medical device software (Article 12)
- Prescribe a new facility, manufacturing, and quality control system for innovative medical device software instead of applying the facility, manufacturing, and quality control standards in the Medical Devices Act
I. Prescribe assistance for the timely implementation of clinical trials, etc. (Article 13)
- Prescribe procedures and methods, etc., necessary when intending to seek assistance in preparing a clinical trial protocol under Article 28 of the Act
J. Prescribe procedures and methods, etc., necessary for technical support and standardization projects for innovative medical devices (Article 14, Article 15)
- Prescribe procedures and methods, etc., for technical support, etc., for innovative medical devices in accordance with Article 28 of the Act
K. Prescribe the scope, method, etc., of investigations into the manufacture, import, use, etc., of innovative medical devices (Article 16, Article 17)
- Prescribe matters concerning access/investigations by public officials under the current Medical Devices Act
L. Calculate fees for staged reviews and prioritized reviews of innovative medical devices (Article 19)
- Prescribe fees and standards on fee reductions and exemptions for staged reviews and prioritized reviews of innovative medical devices
M. Newly insert administrative measures (attached Table 5)
- Prescribe separate standards on administrative measures taken against violations of the Innovative Medical Devices Act in accordance with Article 37 of the Act