On July 1, 2021, Shanghai Shift Electrics Co., Ltd. received the MDSAP certificate issued by SGS. From the first system training on July 1, 2020, after a series of work such as preliminary investigation, detailed diagnosis, training, rectification guidance and special guidance, simulation audit, formal audit, and re-rectification, Shift finally successfully obtained the certificate after a full year and became the second company in Shanghai obtains the MDSAP certificate.
Medical Device Single Audit Program (MDSAP) is a project jointly initiated by members of the International Medical Device Regulators Forum (IMDRF). It aims to conduct a single audit of medical device manufacturers through a third-party audit agency to meet the different QMS/GMP requirements of participating countries. Enterprises and organizations that pass the MDSAP audit can enter multiple markets with a single audit. At present, the project has been recognized by the US Food and Drug Administration FDA, Health Canada, Australia TGA, Brazilian Health Bureau ANVISA and Japan's Ministry of Health, Labor and Welfare MHLW. From January 1, 2019, MDSAP will replace CMDCAS as the Canadian medical device access review program.
Shanghai Shift Electrics is one of the earliest private enterprises in China to develop and produce electric toothbrushes. It has always focused on the field of oral cleaning products. At present, Shift has more than 100 product technology innovations and invention patents, providing ODM and intelligent manufacturing 360-degree full-service for many world-renowned brands.
The MDSAP certificate is another important achievement obtained by Shift after passing ISO13485 medical device system certification, ISO9001 quality system certification, and ISO14001 environmental system certification. It has enhanced the competitiveness of Shift’s expansion into Canada, Brazil, Japan, Australia and the United States. We believe Shift will continue to obtain more honors, to expand the market into a next high level.