Ministry of Commerce: Starting from April 1st! New regulations for the export of medical supplies
The current global epidemic situation is severe. In order to meet the needs of domestic epidemic prevention and control On the basis of this, enterprises are encouraged to expand production capacity, export in an orderly manner, and provide the best possible assistance to the international community in fighting the epidemic. According to the deployment of the Central Leading Group for Response to the New Coronavirus Epidemic, the Ministry of Commerce, together with relevant departments, has established a working mechanism to conduct strict quality control of relevant medical supplies. Control and severely crack down on counterfeit and shoddy activities.
According to the announcement jointly issued by the Ministry of Commerce, the General Administration of Customs, and the Food and Drug Administration, relevant medical supplies for export must obtain national drug The relevant qualifications of the regulatory authorities must meet the quality standards of the importing country (region). At the same time, it is also hoped that foreign buyers will choose product suppliers that meet the above quality requirements. Once quality problems occur in the export of medical supplies, they will be carefully investigated and every case found will be investigated and punished. They will be punished in accordance with the law and will never be tolerated. Currently, cross-border e-commerce platforms including Alibaba and MIC will suspend the uploading of Chinese medical supplies until suppliers submit relevant qualifications or business licenses for medical products before these products can be re-launched online.
The Ministry of Commerce issued an announcement last night: During the special period of epidemic prevention and control, in order to effectively support the global fight against the epidemic and ensure product quality and safety , standardizing the export order. Starting from April 1, companies exporting new coronavirus testing reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers must provide a written or electronic statement (see attachment 1 for the template) when declaring to the customs. , committed to exporting products that have obtained China’s medical device product registration certificate (see Appendix 2 for relevant registration information) and comply with the quality standards of the importing country (region). The customs shall inspect and release medical devices based on the medical device product registration certificate approved by the drug supervision and administration department. The above-mentioned export quality supervision measures for medical supplies will be dynamically adjusted depending on the development of the epidemic.
Export medical supplies declaration template China’s relevant medical device product registration information (dynamically updated on the State Food and Drug Administration website nmpa.gov) State Food and Drug Administration new coronavirus detection reagent registration information (total 23 companies)
Domestic ventilator registration information from national and provincial drug regulatory authorities (62 in total, 35 randomly intercepted)
Provincial drug regulatory department medical protective clothing registration information (301 companies in total, 35 companies were randomly intercepted)
Let’s talk about EU CE certification and US FDA certification
(Click the text below to view directly)
①Export EU CE certification may be changed to MDR, and only 12 institutions can issue certificates
②This is the EU CE and US FDA required for export Certification requirements (with mask export requirements from various countries)
③ For mask export, it is enough to read this article! Detailed export customs guidelines…
Zero tolerance for shoddy, counterfeit and shoddy epidemic prevention materials, strict investigation, strict crackdown, and heavy fines!
▲Mask? check! !
The intensity and determination of the customs crackdown this time completely exceeded the expectations of the industry! How strict is this strictest inspection of medical supplies in history? Let’s take a look at the information disclosed on the official website of the General Administration of Customs:
Hurry! ! In just 4 days, 11.205 million pieces of illegal materials were seized!
From March 31st to April 5th, from the notice of crackdown to the release of data, the customs only took 4 days, but the number of seizures was huge!
According to the official announcement of the General Administration of Customs, since the announcement of strict inspection and crackdown, the customs has seized a total of 11.205 million medical supplies produced by non-listed enterprises or without medical device product registration certificates, including :
9.941 million masks
155,000 sets of protective clothing
New Crown 1.085 million virus detection reagents
24,000 infrared thermometers
11.205 million pieces were seized in 4 days, which is an average More than 2.8 million substandard epidemic prevention materials are seized every day! And as the crackdown deepens and is fully launched, the average number of seizures per day is likely to increase.
All! ! Sea, land, air, parcel express and cross-border e-commerce channels are all under investigation!
This customs inspection is not only quick but also very wide-ranging. According to information from the General Administration of Customs, the illegal epidemic prevention materials inspected are not only transported by sea, air and land, etc. Traditional trade also includes channels such as mail, express mail and cross-border e-commerce where some merchants believe that customs may relax supervision!
Cruel! ! Any non-compliance or non-compliance�Will be investigated
The intensity of the customs crackdown is also reflected in another aspect, that is, any non-compliance involving masks and other anti-epidemic materials may be investigated!
According to the official website of the General Administration of Customs, for the medical supplies listed in the “Announcement”:
●Implement 100% document review
● Focus on checking whether the product name and quantity are consistent with the declaration
● Whether the appearance is mildewed and polluted/contaminated
● Whether the shelf life has expired
● Whether it is damaged and infringed upon
● Whether there are clips Hiding, adulteration, passing off fake as genuine, substandard goods as good, substandard goods as qualified goods, etc.
From the above statement of the General Administration of Customs, we can see that What is checked is not only whether the anti-epidemic materials are qualified, whether there are registration certifications and other “routine” items considered by the industry, but all aspects of anti-epidemic materials will be checked.
Customs announces four typical cases
Case 1: Falsification and concealment Report on the export case of new coronavirus detection reagents
On April 2, Shanghai Customs conducted inspections and seized “rapid diagnostic test strips” exported by a Hangzhou biotechnology company, which were actually new coronavirus tests. Reagents, a total of 122,000 copies.
Case 2: Export case of hidden masks
On April 2, Ningbo Customs declared export to a company in Yiyang City, Hunan Province During the inspection of a batch of goods, in addition to the declared wet wipes, plastic bags and other goods, 15 boxes of masks were seized, totaling more than 40,000 pieces.
Case 3: False concealment of the export of new coronavirus testing reagents
On April 1, Beijing Customs conducted an air freight control and discovered that a Beijing biotechnology company had falsely declared the exported COVID-19 testing reagents as “rapid test strip cards” to evade customs supervision, involving 300 boxes of COVID-19 testing reagents.
Case 4: Case of hiding 15 boxes of masks
On April 2, Daxie Customs, a subsidiary of Ningbo Customs, conducted a surveillance operation in Yiyang City During the inspection of a batch of goods declared by a company to be exported to Cote d’Ivoire, it was found that in addition to the declared goods, wet wipes, plastic bags, etc., there were 15 boxes of masks, totaling 40,500 pieces, and the outer packaging was marked with CE, FDA, and SGS certification marks.
Customs solemnly warns!
Regarding the illegal activities of exporting medical supplies seized by the customs, the companies involved will be severely dealt with in accordance with laws and regulations:
1 For those who evade customs supervision by false declarations, the customs will confiscate smuggled goods and illegal gains in accordance with the provisions of the “Customs Law” and “Customs Administrative Punishment Implementation Regulations”, and may impose a fine;
If a crime is constituted, the judicial organs may, in accordance with the relevant provisions of the Criminal Law, impose fixed-term imprisonment or criminal detention, and concurrently or solely a fine, depending on the circumstances.
Secondly, for exported medical supplies that are adulterated, passed off as fake, passed off as substandard, or passed off as substandard goods as qualified goods, the customs shall comply with the “Import and Export Commodity Inspection Law” “, order the export to stop, confiscate the illegal income, and impose a fine of not less than 50% but not more than three times the value of the goods.
Third, the above-mentioned illegal acts punished by the customs will be used as a reference for the customs to determine the credit status of enterprises.
If it constitutes smuggling or smuggling crime, the customs will directly reduce the credit rating of the enterprise to a dishonest enterprise, and implement measures such as increasing the inspection ratio, increasing the frequency of audits, and collecting the full guarantee deposit, etc. Strict management measures. At the same time, the General Administration of Customs will also jointly punish the enterprise with relevant national departments.
The fourth is to increase the exposure of the illegal activities of the punished enterprises, disclose relevant information of the punished enterprises on the official website of the General Administration of Customs and local credit websites, and expose relevant cases through the media information.
▲Epidemic prevention supplies? check! !
Strict inspection by customs is no joke, not to mention that this time it is life-threatening epidemic prevention supplies. Legality, compliance, quality and truthful declaration are the right way to export all epidemic prevention materials including masks! </p
