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Efficacy and Safety of Pharmaceuticals

Application for approval of R-SUDs (1) For marketing of R-SUDs, premarketing approval under Article 23-2-5, Paragraph 1 of the Act or premarketing approval of foreign manufactured medical devices under Article 23-2-17, Paragraph 1 of the Act (hereinafter, “approval”) is required as a different product item from the original medical device. (2) R-SUDs must conform to the Reprocessing Standards. (3) For submission of an application for approval of an R-SUD, the applicant must pay a prescribed fee as a medical device listed in Article 12, Paragraph 1, Item 1. A (2) or (4) of the “Order for Fees related to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (Cabinet Order No. 91 of 2000; hereinafter, “Fee Order”). (Article 3 of the Amended Fee Regulations) (4) The device class of the R-SUDs shall be the same as that of the original medical device in principle. If the original medical device is recognized as Class I, General Medical Device, the corresponding R-SUD shall be recognized as Class II, Control Medical Device irrespective of “Amendment of the Classification Rules for Specially Controlled Medical Devices, Controlled Medical Devices and General Medical Devices” (Notification No. 0510-8 by the PFSB Director-General, MHLW, dated May 10, 2013). 3 MAH authorization of R-SUDs (1) R-SUDs shall be marketed by medical device marketing authorization holders in accordance with Article 23-2, Paragraph 1 of the Act or marketing authorization holders designated according to the provisions in Article 23-2-17, Paragraph 1 of the Act (hereinafter referred to as “MAHs of R-SUD”). (2) In the reprocessing process of SUDs, it is critical to ensure implementation of cleaning and sterilization. To this end, MAHs of R-SUDs are required to comply with the following provisions as specified in Article 23-2-15, Paragraph 1 of the Act. Identically to the manner by which medical devices classified as biological products are handled, MAHs of R-SUDs shall appoint a person with appropriate knowledge of bacteriology to provide support to the general marketing supervisor responsible for medical devices products in cases where the general marketing supervisor,