Exports Of Anti Epidemic Medical Materials Have Been Tightened? Multi Departmental Dispatch

At present, there are many problems in anti epidemic medical devices, including unlicensed production and sales, unregistered products, and false propaganda.

On the evening of March 31st, the Ministry of Commerce, the General Administration of customs and the State Drug Administration issued a notice on the orderly export of medical materials. The announcement said that in order to effectively support the global fight against epidemic situation, ensure product quality and safety, and standardize export order, from April 1st onwards, enterprises exporting new coronavirus test reagents, medical masks, medical protective clothing, respirators and infrared thermometers must submit books or electronic statements when declaring customs to the customs. The quality standard requirements of importing countries (regions). The customs shall examine and release the medical device product registration certificate approved by the drug supervision and administration department. The export quality supervision measures of these medical materials will be dynamically adjusted according to the development of the epidemic situation.

A senior medical profession pointed out to the first financial reporter that at present, there are many problems related to the epidemic related medical devices, including the production and sale of unlicensed products, unregistered products and false propaganda. Despite the different standards of execution of masks for different uses, objective reasons such as nucleic acid detection, sampling and manipulation are not standardized. But unlicensed production and sales of unregistered products are quite common.

It is understood that before the announcement, medical device exports, if the recipient countries do not require the export documents issued by the SFA, but only need CE certification or FDA card, the enterprises do not need to obtain the registration certificate and production certificate granted by the Chinese regulatory authorities.

With this announcement coming into effect today, during the epidemic period, the export registration of anti epidemic medical device products must be approved by the Chinese regulatory authorities.

These people also told reporters: "this specification landing, and CE certification industry chaos has a great relationship. There are various types of CE certification, covering different product categories, but CE certification is awarded by third party organizations, and the third party certification organizations of these intermediaries are of integrity and level.

In addition, at the end of the product, the news of counterfeit and inferior products and unqualified products is frequent. Shi Lichen, founder of Ding Chen, Beijing, told reporters: "with domestic masks, the quality is also uneven. Some approve production, some do not approve production, but temporary production. The approved production can basically control the quality according to the relevant standards. Basically, the production standard is not met without approval. "

It is noteworthy that foreign ministry spokesman Hua Chunying said at a regular press conference held in March 30th that many countries recently procure medical supplies in the Chinese market. On the premise of guaranteeing the demand for domestic epidemic prevention, China supports qualified and reputable enterprises to export to the outside world, and provides convenience for all countries to purchase and export their enterprises in an orderly way in production, transportation and customs clearance.