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Regenerative and Cellular Therapy Products

Registration of manufacturer of R-SUDs (1) During the reprocessing process of SUDs, it is critical to ensure implementation of cleaning and sterilization. Implementation of the following steps in the manufacturing process of R-SUDs shall be registered pursuant to Article 23-2-3, Paragraph 1 of the Act or Article 23-2-4, Paragraph 1 of the Act (Article 114-8, Item 4 of the Amended Enforcement Regulations). [1] Design [2] Receipt, disassembling, and cleaning etc. of used SUDs The relevant steps cover a place for temporarily storage of SUDs that were used but have not been cleaned and a step for inspecting used SUDs received from medical institutions in terms of whether they can be supplied with respect to the subsequent reprocessing processes. [3] Primary assembly and other principal manufacturing steps (other than design, receipt of used SUDs, disassembling, cleaning, sterilization and storage). [4] Sterilization [5] Storage of finished products in Japan (2) During the reprocessing process of SUDs, it is critical to ensure implementation of cleaning and sterilization. In light of this, the following compliance rule for manufacturers of medical devices specified in Article 23-2-15, Paragraph 2 of the Act is stipulated: Such manufacturers shall appoint a physician, or a person with appropriate knowledge of bacteriology or expertise in sterilization of medical devices as an assistant to the technical supervisor of medical devices at the manufacturing site for reprocessing of SUDs (except for storage of the finished product in Japan) in cases where the relevant technical supervisor of medical devices is not a physician or does not have the knowledge and experience described previously (Article 114-54-2 of the Amended Enforcement Regulations). 5 Persons with appropriate knowledge of bacteriology are as described in 3 (2). Persons with expertise in sterilization of medical devices shall be ones certified as Type 1, Sterilization Technologist by the Japanese Society of Medical Instrumentation or shall be ones who have skills comparable to the above.