The Party Central Committee and the State Council attach great importance to the export of medical supplies and require the Ministry of Commerce to work with relevant departments to strictly control quality, maintain export order, and severely crack down on counterfeiting and shoddy activities.
The quality and safety of medical supplies is directly related to people’s lives and health. Once quality problems occur in the export of medical supplies, we will investigate them carefully and investigate and deal with them if they are discovered. We will punish them in accordance with the law and will never tolerate them.
Source: Ministry of Commerce of the People’s Republic of China
Masks frequently “overturn” when exported overseas. This important factor may be a hidden reason for further tightening of export controls
“The epidemic currently has the possibility of continuing to spread around the world. Enterprises also plan to switch to export sales when the domestic market is saturated, but export products need to obtain relevant certifications from various regions. The certification time cycle is long and carries greater market risks. Therefore, it is recommended that all enterprises fully investigate the current market situation before putting into production.” This is the public statement made by the Guangdong Provincial Medical Device Management Association half a month ago, clearly raising the risks of epidemic prevention products going overseas.
However, not long after the release of this document, news of mask companies “overturning” overseas began to spread frequently. From the fact that the CE certification is not recognized by overseas customs, a large number of masks cannot be cleared smoothly, and due to quality problems, the Dutch Ministry of Health ordered the recall of about 600,000 masks imported from China that had been sent to medical institutions. It was originally thought that after the domestic supply of masks eased, there would still be opportunities in overseas markets. However, what many companies did not expect was that there were many twists and turns in going overseas.
“It is very easy to produce masks now, and exporting can still be done for a while, but exporting is not easy. As far as I know, many masks exported to the EU in Shenzhen have also been returned recently.” On the 30th. , when talking about the recent turmoil in the export of masks, an insider from a mask manufacturing company in East China told reporters this.
“The main reason is that some small businesses do not understand the relevant laws and regulations of export certification, and they find unreliable third-party consulting agencies in the market, or the certification agencies that issue certificates are not qualified enough, resulting in the The CE certificate is not recognized by the EU at all.” The other party further explained.
In fact, “novice” export companies have encountered unscrupulous intermediaries. Reporters have heard about the recent chaos in the certification market.
According to some industry insiders, in order to seize the window period of the epidemic, mask export companies have high requirements for “speed” and hope to find the fastest and most convenient overseas channels. In this case, some intermediaries have also thoughtfully launched “expedited certification” services, and even misled manufacturers to take certification channels that do not meet regulatory requirements, such as lowering standards and lowering risk levels for certification.
Public information shows that masks can be roughly divided into two categories: ordinary masks and medical masks. According to relevant customs regulations, production companies or foreign trade companies with import and export rights can directly export personal protection or ordinary industrial masks, so the threshold is not high.
However, medical masks are medical devices, so their export management is more stringent. If a production enterprise has import and export rights, it can export directly; if the enterprise does not have import and export rights and needs to export through a foreign trade company, the foreign trade company needs to have a legal and valid business license (including medical device sales within the business scope) and conduct For Class II medical device registration, the manufacturer’s medical device-related qualification certificate and test report must be attached when exporting.
In addition, since the importing country has certification or registration requirements for medical devices such as masks, such as US FDA certification, EU CE certification, etc., domestic manufacturers must also conduct certification in advance according to the relevant requirements of the country where foreign customers are located. . Taking the EU CE certification as an example, if you want to obtain a formal CE certificate, you must find a formal certification agency, which is an agency (notified body) authorized by the EU to issue CE certification. Internationally renowned testing and certification agencies such as SGS, TUV, Intertek, etc. are such well-known and authoritative certification agencies.
However, public information shows that although there are more than 2,000 notified bodies recognized by the EU, due to the different professional fields of each CE certification body, not all of these notified bodies can do CE for masks. Certification. What makes it even more difficult to identify is that the entire industry is still filled with a large number of irregular certification agencies. For example, many leather bag companies registered in Europe have also applied for notified bodies and can directly issue CE certificates, but such certificates are not accepted by foreign customers. Approval; some claim to be able to produce reports quickly and at low prices, but in actual operation they may not do sample testing, or they may not conduct testing completely in accordance with standards, thus saving time and money on testing.
“The existence of such irregular institutions is because there are many customers with such needs in the market. They hope that they do not need to do testing, as long as the institution can issue a report to meet the export customs clearance requirements.” Someone also It is pointed out that “the consequences of such false reports in violation of regulations are that not only are manufacturers or traders prone to losing the trust of customers, but they may even have to bear the consequences of violations of inconsistent product quality and face huge business risks.”
Faced with the recent situation that anti-epidemic materials such as masks and new coronavirus rapid testing products have received negative reviews after being exported, relevant national departments have also begun to strengthen the quality control of exports of medical materials.reason. According to the Ministry of Commerce, the Ministry of Commerce, together with the General Administration of Customs and the Food and Drug Administration, will issue an announcement in the near future, requiring that relevant medical supplies for export must obtain relevant qualifications from the national drug regulatory authorities and meet the quality standards of the importing country (region).
Relevant news from the Shanghai Customs public account shows that the current export of medical masks requires companies to provide a medical device product registration certificate or registration certificate issued by the drug regulatory department, but protective clothing, new coronavirus detection kits, etc. Other products do not have similar requirements yet.
However, even so, the export of these products still needs to meet the access conditions of the importing country, such as obtaining CE certification. In this regard, the customs specifically pointed out that the access certification license required by these importing countries must be It is a certification certificate issued by a certification agency designated by the importing country.
</p
