Plastic Cupping Imported From Korea Has Returned

Recently, Inspection and Quarantine Bureau in Weihai when a company's imports from South Korea to test a number of plastics found in the consignment of 12 boxes of plastic cupping is a first class medical devices. Batch of plastic cupping is not implemented for the record, does not comply with the relevant provisions of "Medical Devices Regulations," the. Weihai Inspection and Quarantine handle returned by law to make a decision on the goods. At present, the goods have been returned back to Korea, this is the first port in Shandong returned Korea imported plastic cupping.

Our implementation of medical devices classified in accordance with the level of risk management, the implementation of the first class of medical devices product record management, second class, third class medical device product registration management practice.

The second category of imports, Class III medical devices, by the State Food and Drug Administration; documents inlet of the first class of medical equipment, food and drug administration under the State Council shall submit filings departments and authorities of the exporting country to allow sale of medical devices administration review, approval issued medical Device Registration Certificate.

In addition, the import of plastic medical devices should be instructions in Chinese, Chinese label. Brochures, labels should comply with the relevant mandatory standards and requirements.