Tentative translation of MHLW MO 169 revised in 2021, Chapter 5-2 (Note) 1) This English document is only for reference purpose. In case of any discrepancy, the Japanese text shall prevail. 2) The requirements of MHLW MO 169 are applied to both the Marketing Authorization Holder and the person operating the Registered Manufacturing Site. In this document the requirements are stipulated as the requirements for the Marketing Authorization Holder. Meanwhile, when they are applied to the Registered Manufacturing Site, the requirements must be paraphrased, as appropriate. (Definition) Article 2 27. The term, “re-manufactured single-use medical devices,” in this MHLW Ordinance means medical devices for single use (medical devices that can be used only once; hereinafter the same), which have been re-manufactured (inspection, disassembly, cleaning, sterilization, and other necessary processing for the purpose of newly manufacturing and marketing single-use medical devices after use; hereinafter the same). 28. In this Ordinance, "recycled parts" refer to all or part of single-use medical devices used in medical institutions among parts, etc. specified in Paragraph 3 and are supplied for remanufacturing. (Scope of application) Article 3 4. Marketing authorization holders, etc. shall implement manufacturing control and quality control for products related to re-manufactured single-use medical devices in accordance with the provisions of Chapter 2 and Chapter 3 as well as the provisions of Chapter 5-2. Chapter 5-2. Manufacturing control and quality control of re-manufactured single-use medical devices (Infrastructure for operation at a registered manufacturing site of a marketing authorization holder, etc. of re-manufactured single-use medical devices) Article 81-2 Marketing authorization holders, etc. of products related to re-manufactured single-use medical devices (hereinafter referred to as "marketing authorization holders, etc. of re-manufactured single-use medical devices") shall meet the following requirements as an infrastructure for operation at a registered manufacturing site (excluding registered manufacturing sites that only design in the manufacturing process or store finished products in Japan; the same shall apply hereinafter in this chapter) that manufactures the products. [1] Work areas shall conform to the following requirements. 1 / 5 B. Re-manufacturing clean areas (work areas where recycled parts are exposed to the air in the work areas after pathogenic microorganisms and other causes of diseases are inactivated or removed; the same shall apply in this chapter) shall have a drainage facility conforming to the following requirements. (1) The facility shall have an appropriate structure to prevent contamination by harmful drainage. (2) The facility shall have a structure that can be easily cleaned or disinfected B. There should be facilities listed below. This shall not apply if it is considered obviously unnecessary. (1) Areas where recycled parts contaminated by pathogenic microorganisms or other causes of diseases are handled: Facilities for cleaning, drying, and sterilization of recycled parts, facilities for cleaning, disinfection, and sterilization of apparatuses used in the areas, and facilities for treatment of waste fluids, etc. (2) Facilities necessary for cleaning, disinfection, drying, and storage (including drainage facilities to prevent contamination by harmful drainage) of transportation containers (containers for transporting single-use medical devices used in medical institutions, which have not been cleaned or sterilized; the same shall apply hereinafter in this chapter) C. The following testing facilities and apparatuses are provided. This does not apply to cases where testing is performed by using other testing institutions of a marketing authorization holder, etc. of re-manufactured single-use medical devices on their own responsibility without any problem. (1) Facilities and apparatuses to verify that recycled parts which have undergone inactivation or removal of pathogenic microorganisms and other causes of diseases are not contaminated by the microorganisms (2) Other facilities and apparatuses necessary for testing [2] Areas, where recycled parts contaminated by pathogenic microorganisms or other causes of diseases are handled, shall be clearly separated from the other areas and have dedicated facilities and apparatuses to conduct the manufacturing. In the manufacturing process after