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Regional Comprehensive Economic Partnership Agreement (RCEP)

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Nov 27,2020

Validation And Process Are Common In Medical Device R&D And Production

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"The Regulations on the Supervision and Administration of Medical Devices" requires that "the quality management standards for the production of medical devices shall provide clear provisions on matters affecting the safety and effectiveness of medical devices, such as the design and development of medical devices, production equipment conditions, raw material procurement, production process control, enterprise organization, and staffing".

Jun 07,2020

ISO13485 Medical Device Quality Management System

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"Medical Device" means any product used for the diagnosis, prevention, and treatment of diseases, ranging from wound dressings and pacemakers to dental chairs, life-sustaining instruments, and in vitro diagnostic reagents.

Apr 24,2020

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