Recently in Guangzhou Customs District, two batches of medical devices were returned abroad on account of their non-compliance with relevant requirements. The import devices included 110 pieces of ultra-pulsed plasma cutting rings from Britain and 13 catheters from Poland, totally worth 26,427 US dollars.
According to Panyu Customs House in charge, the inspectors found that the cutting rings from Britain were not accompanied by medical registration information, Chinese instruction book and Chinese label, and that the catheters from Poland were not provided with valid Registration Certificate for Import Medical Device.
As per relevant regulations of China, an importer of medical device must submit to Customs the Registration Certificate for Import Medical Device that is issued by competent Drug Administration; an import medical device should be accompanied by its Chinese instruction book and Chinese label in line with relevant compulsory standards; such information as the country of origin, and importer name, address and contacts, should be provided in the Chinese instruction book and label.
Customs reminder: the importer should also make sure that a medical device from abroad is compliant with the access requirements of China, avoiding the denial of entry by the Customs.
General Administration of Customs of the People's Republic of China
Address: No.6. Jianguomennei Avenue, Dongcheng District, Beijing, China Postcode: 100730