Tentative translation of MHLW MO 169 revised in 2021, Chapter 4 (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. Chapter 4. Manufacturing control and quality control of biological medical devices, etc. (Infrastructure for operation at a manufacturing site of a marketing authorization holder, etc. of specified biological medical devices, etc.) Article 73 Marketing authorization holders, etc. (hereinafter referred to as "marketing authorization holders, etc. of specified biological medical devices, etc.") of products related to medical devices and cell/tissue-based medical devices (hereinafter referred to as "specified biological medical devices, etc." in this chapter), such as medical devices, etc. as specified biological products, designated by the Minister of Health, Labour and Welfare pursuant to the provisions of Paragraph 2, Article 43 of the Act shall satisfy the following requirements as an infrastructure for operation at manufacturing sites that manufacture the said products (excluding manufacturing sites that only perform packaging, labeling, storage, or design; the same shall apply in this chapter). [1] Facilities supplying distilled water, etc. necessary for manufacturing products shall have a structure necessary for preventing contamination of distilled water, etc. by foreign matters or microorganisms (including viruses; the same shall apply hereinafter in this chapter and Chapter 6). [2] Workplaces (places where manufacturing operations are performed; the same shall apply in this chapter and through Chapter 6) shall conform to the following requirements. A. Work rooms or controlled work areas should have structures and facilities that can maintain and control appropriate temperature, humidity, and cleanliness according to the manufacturing process. B. Work rooms for weighing of raw materials or materials or cleaning of containers should have a well-closed structure for dust prevention. C. Work rooms for drying or sterilization of containers after cleaning should be dedicated. 1 / 11 This does not apply if there is no risk of contamination of cleaned containers. D. Clean areas (work areas where weighing and preparation of parts, etc. are performed and where products, etc. are exposed to the air in the work areas after cleaning; the same shall apply hereinafter in this chapter and Chapter 6) and aseptic areas (work areas where sterilized products, parts, etc., or sterilized containers are exposed to the air in the work areas, areas where closure of containers is performed, and areas where aseptic operations, such as sterility testing, are performed; hereinafter the same in this chapter.) shall conform to the following requirements. (1) The surfaces of ceilings, walls, and floors are smooth and free from cracks and do not cause dust. (2) Drainage facilities have an appropriate structure to prevent contamination by harmful drainage. E. Do not install drainage ports in clean areas. This shall not apply to the following cases. (1) Drainage ports are equipped with traps that are easy to clean and devices to prevent backflow of drainage. (2) Traps have a structure to allow disinfection. (3) A ditch of the floor is shallow and easy to clean and connected to the outside of manufacturing areas (places where culture, extraction, and purification, weighing and preparation of parts, etc., cleaning and drying of containers, closure and packaging of containers, and gowning are performed) through drainage ports. F. Aseptic areas shall conform to the following requirements. (1) Do not install drainage ports. (2) Do not install sinks. G. Areas where tests using animals or microorganisms are performed and areas where animal tissues or microorganisms not necessary for manufacturing products related to specified biological medical devices, etc. are handled shall be clearly separated from the other areas where the said products are manufactured, and an air-handling system shall be separated. H. Areas for aseptic operations shall be provided with clean air treated with filter

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