From April 1, the new regulations on the export of medical supplies such as masks were implemented
日期:2020-04-17 编辑:ANSON nanobiotechnology (Zhuhai) Co., Ltd.
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As the spread of overseas epidemic accelerated, China's medical supplies such as masks and thermometers entered a phase of high output.

But recently, the export mask quality problems are frequently exposed.


Yesterday, the ministry of commerce and relevant departments issued a notice, starting from April 1 will implement the new export regulations of medical materials.


Starting from April 1, medical supplies must be exported with a written or electronic declaration


On the evening of May 31, the ministry of commerce, the general administration of customs and the national medical products administration jointly issued a notice on the orderly export of medical materials:



The announcement said that at present, the global epidemic is accelerating the spread of the situation.

On the basis of good epidemic prevention and control, orderly export of medical materials is an important measure to deepen international cooperation on epidemic prevention and control and jointly tackle the global public health crisis.


In epidemic prevention and control of special period, to effectively support the global fight against the disease, to ensure product quality and safety, standardize the order of export, since April 1, the export will be coronavirus detection reagent, surgical masks, medical protective clothing, breathing machine, infrared thermometer enterprise declare to the customs, shall provide a written or electronic statement (see appendix 1). Commitment to export products have made our country medical equipment product registration certificate (see attachment 2) relevant registration information, as to meet the requirements of the quality standards of importing countries (regions).


The customs shall release the medical device product registration certificate approved by the pharmaceutical supervisory and administrative department.

The above-mentioned quality control measures for the export of medical materials will be adjusted dynamically according to the development of the epidemic situation.


At the same time, it stressed that relevant medical material export enterprises should ensure the quality and safety of their products, meet relevant standards and requirements, and actively support the international community in fighting against the epidemic.


Annex 1 mentioned in the announcement is the declaration template for the export of medical materials, which is as follows:



Annex 2 shows that currently, the enterprises that have obtained the registration certificate of medical device products in China include:


Sfda novel coronavirus detection reagent registered 23 companies


There are 62 registered companies of domestic ventilator in national and provincial drug supervision departments


There are 301 registered medical protective clothing companies in provincial drug regulatory departments


There are 150 registered companies of medical protective masks in provincial pharmaceutical supervision departments


There are 523 registered medical surgical mask companies in provincial drug administration departments


Provincial drug authorities registered 752 companies that used disposable surgical masks


Provincial drug supervision departments infrared thermometer (including ear thermometer, forehead temperature gun) registered 236 companies


In fact, before the announcement, the ministry of commerce had said it would strengthen quality control over the export of medical materials together with relevant departments.


The ministry of commerce said that the quality and safety of medical materials is directly related to people's lives and health.

The ministry of commerce, together with the general administration of customs and the state administration of food and drug administration, will issue a notice requiring the export of related medical materials to obtain the relevant qualifications of the national drug regulatory authorities and meet the quality standards of the importing country (region), the official said.

Soon after that came the announcement on April 1st.


As soon as the announcement was made, the logistics channel responded quickly. Some companies issued the following urgent notice:


Requirements for mask export declaration documents (three certificates of the manufacturer)


1. Business license of the manufacturer


2. Production license of medical devices


3, the manufacturer's mask test qualified report


In addition, the certificate of qualification required for customs clearance in the destination country is also necessary, such as FDA, CE, etc.


Many companies said: about the mask export, from April 1, the customs will strictly check the export of epidemic prevention materials, for no qualification certification of the three no masks, if the export was the customs spot check will be detained for customs clearance processing, may also be detained for destruction!


When each customer purchases, must look for the factory that has attestation to buy, lest cause unnecessary loss!


It is expected that a number of businesses producing and selling substandard medical supplies will be cleaned.


In order to save themselves, many sellers to do epidemic prevention materials export


The export of epidemic prevention materials affects the sensitive nerves of many cross-border e-commerce sellers.


So far, more than 850,000 cases have been confirmed globally, with more than 40,000 deaths.

The number of confirmed cases in the United States rose to 180,000, with New York state overtaking hubei province.

Under the background of the rapid development of the global epidemic, many sellers have to turn to the export of epidemic prevention materials in order to save themselves.


On March 17, amazon's sellers in China were informed that they would not be allowed to stock any of the six non-essential items on their European and American sites until April 5.

A few days ago, amazon sent another notice, saying that after April 5, necessities are still in priority for storage, but some non-necessities can be replenished.

Some of the skus can the delivery plan, but many products still cannot be put into the warehouse, the specific time to be put into the warehouse is still unknown.


Since the non-essential goods can not enter the warehouse, most of the seller orders seriously plunged, in order to survive, many sellers began to "save themselves", some people will expand the sales category to masks, disinfectant, protective clothing and other epidemic prevention supplies.


Source: billion media