进口医疗器械需要注意什么？（海关答疑）

Core Points - The article discusses the requirements and procedures for importing medical devices into China, emphasizing the importance of compliance with regulations to ensure quality and safety [2][3][4][6]. Group 1: Import Enterprise Qualification Requirements - Companies engaged in medical device operations must have appropriate facilities and storage conditions that match their business scale and scope, as well as a quality management system and personnel [3]. - For Class II medical devices, enterprises must file with the local municipal government’s drug supervision department and submit relevant documentation [3]. - For Class III medical devices, enterprises must apply for a business license from the local municipal government’s drug supervision department and provide necessary materials [3]. Group 2: Required Documentation for Customs Clearance - Customs requires electronic data verification of the import medical device registration/filing certificates along with the customs declaration form [4]. - Additional required documents include the import contract, invoice, packing list, and any other relevant documentation as requested by customs [4]. Group 3: Declaration of Import Goods Attributes - For Class I medical devices, the goods attribute must be declared as "34-I Class Medical Device" and include "629-First Class Medical Device Filing Certificate" [5]. - For Class II medical devices, the declaration should be "35-II Class Medical Device" with "612-Medical Device Registration Certificate" [5]. - For Class III medical devices, the same declaration applies as for Class II [5]. - Medical device components should be declared as "37-Medical Device Components" and may include relevant registration certificates as necessary [5]. - Products similar to medical devices but not defined as such under regulations should be declared as "38-Non-Medical Device" [5]. Group 4: Other Important Considerations - Imported medical devices must have Chinese instruction manuals and labels that comply with the relevant regulations and standards [6]. - The instruction manual must indicate the origin of the medical device and the contact information of the designated domestic legal entity [6]. - Imports lacking proper Chinese documentation or non-compliant labels are prohibited [6].