A copy of the business license of the enterprise, the registration form of the export sales certificate of medical devices, the registration certificate of medical devices, the production license of medical devices and the commitment letter of authenticity of materials shall be provided for the export of medical devices.
Legal objectivity:
Article 5 The supervision and management of medical devices shall follow the principles of risk management, whole-process control, scientific supervision and social co-governance. Article 44 An enterprise exporting medical devices shall ensure that the medical devices it exports meet the requirements of the importing country (region). Article 2 These Regulations shall apply to the research, production, management, use, supervision and management of medical devices in People's Republic of China (PRC).