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NewsNotice of acquisition of second-class medical device manufacturing and sales license
Notice of acquisition of second-class medical device manufacturing and sales license
Japan Healthcare Research Institute Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo) obtained a Type 2 Medical Device Manufacturing and Sales License (* 1) on November 2, 2021.
With the acquisition of this business license, the Japan Healthcare Research Institute has become able to import, export, manufacture and sell medical devices (* 2) used for the purpose of diagnosing, treating or preventing diseases.
In the “Type 2 Medical Device Manufacturing and Sales License” obtained by the Japan Healthcare Research Institute, of the medical devices classified into 4 levels (* 3), Class I (general medical devices) and Class II (Managed medical equipment) can be manufactured and sold. In addition, on the same day as the acquisition of the manufacturing and sales license, we registered for the medical device manufacturing industry.
■ Details of medical device manufacturing and sales license
Type of permission: Type 2 medical device manufacturing and sales business
Permission number: 13B2X10495
Name of office with main function: Japan Healthcare Research Institute Co., Ltd.
■ Details of medical device manufacturing registration
Registration number: 13BZ201577
Factory name: Japan Healthcare Research Institute Co., Ltd.
*1: Medical device manufacturing and sales license
In Japan, in order to ensure the effectiveness and safety of medical devices, we manufacture and sell them based on the “Act on Securing Quality, Effectiveness and Safety of Pharmaceuticals and Medical Devices (Pharmaceutical Machinery Law)”. Consistent regulations are in place up to post-marketing safety measures. In order to manufacture medical devices or import them from overseas and distribute them to the domestic market, a license for manufacturing and sales according to the item is required.
*2: Medical equipment
Machinery and equipment intended to be used for diagnosis, treatment or prevention of human or animal diseases, or to affect the structure or function of the human or animal body (excluding products such as regenerative medicine) It is the one specified by the government ordinance. The items specified by Cabinet Order are those listed in Appendix 1 of Article 1 of the Pharmaceutical and Medical Devices Act Enforcement Ordinance.
*3: Classification of medical devices
Medical devices are divided into four stages according to the risk to the human body in the event of a malfunction. Class I medical devices (general medical devices) are a group of medical devices with the lowest risk, and those that are considered to have extremely low risk to the human body even if a defect occurs, Class II medical devices (managed medical devices) are This is the second class of medical device group from the one with the lowest risk, and it is considered that the risk to the human body is relatively low even if a defect occurs.