Medical equipment import customs clearance how to do, medical equipment import customs clearance is not difficult, now Bo Jun import customs clearance small make up for you to explain about medical equipment import customs clearance formalities and process introduction of import knowledge.
A, the import of medical equipment procedures and processes
According to the "supervision and management of medical equipment regulations", the export of medical equipment to the territory of China's foreign production enterprises, need to be set up by its representative organization in China or designated as an agent of the enterprise legal person in China, to the State Administration of Pharmaceutical Supervision registration or record.
1, filing
To obtain the "Certificate of Registration of Imported Medical Devices" before import.
2, labeling
"Supervision and Administration of Medical Devices Regulations" provides that the import of medical equipment should be imported with Chinese instructions, Chinese labels. Instructions, medical equipment import customs clearance labeling should be consistent with the provisions of the Regulations and the relevant mandatory standard requirements. In the equipment import customs clearance needs to be set out in the instructions of origin and agent's name, address, contact information. No Chinese instructions, Chinese labels or instructions, labels do not meet the provisions of this article shall not be imported. Chinese labeling in the registration, has been approved by the General Administration of Pharmaceutical Supervision administrative approval, can be changed at will.
3, inspection
Exit Inspection and Quarantine according to law on the import of medical equipment, customs inspection inspection is not qualified, shall not be imported. General Administration of Drug Administration will promptly inform the AQSIQ registration and filing of imported medical equipment. Import port of entry-exit inspection and quarantine to the location of the local
Municipal Drug Administration informed the equipment inspection.
4, mandatory certification
Included in the "implementation of mandatory product certification of the product catalog" of imported medical equipment, the need to pass the mandatory certification by the CNCA, and obtain certification. Entry-Exit Inspection and Quarantine at the time of import, will be implemented to verify the entry.
5, import customs clearance
Medical equipment into China, but also need to go through the medical equipment import customs clearance. Included in the "legal inspection catalog" of imported medical equipment, the Entry-Exit Inspection and Quarantine Bureau can issue "proof of entry inspection and quarantine of goods.
Second, the import of medical devices need to provide the documents:
1, the import of medical equipment registration certificate and business license
2, if the import of medical devices containing prosthetic drug reagent components, you need to provide the China Compulsory Certification (Special Articles Approval Sheet)
3, part of the import of medical devices need to provide an automatic import permit
4 Provide photos, nameplates, technical parameters of imported medical devices, end-use, Chinese manuals, etc.
5, import contracts, packing lists, invoices
6, other documents to be supplemented