AiRato acquired first class medical devices marketing license in Japan.

We are pleased to announce that Airato, Inc (Headquarters: Sendai City, Miyagi Prefecture, Representative Directors: Yuto Kimura and Noriyuki Kadoya) obtained a license for “Type 1 Medical Device Manufacturing and Sales Business” from Miyagi Prefecture on February 21, 2025.

　The acquisition of this business license is based on the provisions of Article 23-2, Paragraph 1 of the Act on Ensuring Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc., and will enable our company to manufacture and sell medical devices.

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License type: Type 1 medical device manufacturing and sales business License

number: 04B1X10003

License acquisition date: February 21, 2025

• About the first-class medical device manufacturing and sales business

The Act on Ensuring Quality, Effectiveness and Safety of Pharmaceuticals, Medical Devices, etc. prescribes various legal regulations at each stage of research and development, manufacturing and sales, distribution and post-manufacturing and sales in order to ensure the quality, effectiveness and safety of pharmaceuticals, medical devices, etc. Manufacturing and selling pharmaceuticals, medical devices, etc. requires permission and approval from the Ministry of Health, Labor and Welfare and prefectures. Medical devices are classified into classes I to IV according to the intended purpose of use and the degree of risk, and the type of business license required varies depending on the class. Type 1 medical device manufacturing and sales businesses are authorized to handle all medical devices of classes I to IV.