The troublesome legal inspection of medical supplies exports was thought to have been settled with the official announcement from the General Administration of Customs yesterday. But unexpectedly, there will be a new reversal today!
Just now, the General Administration of Customs issued a notice on the “Customs Implementation of Statutory Inspection Work Plan for Exported Medical Materials” ( The Ministry of Supervision and Administration issued “2020” No. 72), giving an authoritative explanation for the specific operations of yesterday’s Customs Announcement No. 53! Clarification: For the 11 types of exported medical materials listed in Announcement No. 53, enterprises must declare through a single window. Different from other exported goods subject to legal inspection, this new export of legally inspected medical materials adopts a verification management method and does not require the implementation of origin inspection. , no electronic export ledger is required during customs declaration.
It is understood that in actual operation, the previous normal declaration is still followed and the order will not be refunded. But almost 99% of them will be checked.
Notice of the “Customs Implementation Work Plan for Statutory Inspection of Exported Medical Materials” (issued by the Department of Supervision) 2020″ No. 72), the content summary and interpretation are as follows:
In accordance with the requirements of Document No. 72, for the 11 categories (19 commodity codes) of exported forensic medical materials specified in Announcement No. 53 , adopts a verification management method, that is, no product quality inspection is required, no electronic export ledger is required, and the company declares customs declarations normally.
Document submission requirements: For the 5 categories of medical materials in the “Announcement No. 5” issued by the three ministries and commissions, submit the medical device product registration certificate and corporate commitment statement; For medical supplies other than those specified in “Announcement No. 5”, companies must submit a registration certificate and quality and safety commitment letter. For non-medical supplies, companies are not required to submit a registration certificate and quality and safety commitment letter.
Customs review requirements: Announcement No. 5 of the three ministries and commissions involves 5 categories of medical supplies, while Customs Announcement No. 53 involves 11 categories of medical supplies. Among them, 4 categories are the same and 7 categories are different. But these are new measures for medical supplies, not for non-medical supplies. Therefore, the customs declaration system does not set export commodity inspection and supervision conditions for the 19 HSs in Announcement No. 53. The customs adopts the method of electronic review and manual review to process the declaration documents involved in Document No. 53. When it comes to the declaration of export anti-epidemic materials in Announcement No. 53, no electronic ledger is required, and the data does not go through the ECIQ system. The 4 categories of commodities listed in Announcement No. 5 of the three ministries and commissions are handled in accordance with the requirements of Announcement No. 5. The Chinese medical device product registration certificate and enterprise commitment statement are required, and no statutory product inspection is required. For the seven categories of commodities newly added in Announcement No. 53, almost 100% of the comprehensive business positions will manually review the documents. If they are found to have not been released, they can contact the customs document review department. For non-medical use, if it has not been controlled, it will be released directly; for medical use, the company needs to provide a registration certificate (can be an electronic scan) and a quality commitment letter from the export company. If it is uploaded, in principle (risk control or comprehensive business If there are any doubts about the manual review of the document (except for the decision to deploy), the company will be released. Those who do not have the above-mentioned registration certificate or the export enterprise’s quality assurance commitment letter may be released.
Inspection information requirements: If the product involves medical supplies, the company needs to provide registration/filing certificate and quality and safety commitment letter. If it cannot be determined on site or if the company raises objections, it will be sent to the laboratory for testing. Circular No. 72 clarifies that “when determining whether a product is a medical material, it should be based on the characteristics of the product itself rather than the declared purpose.”
In addition, Chongqing Customs also released the rapid customs clearance inspection guide for the export of forensic medical supplies on the public account today. Click to read the original text to view the official notice:
According to the General Administration of Customs Announcement No. 53 of 2020, starting from April 10, export commodity inspection will be implemented on 11 categories of medical supplies under customs commodity numbers such as “6307900010”, involving a total of 19 countries HS code. Previously, health quarantine had been implemented for exported testing reagents.
Export declaration
For the 11 categories of exports listed in Announcement No. 53 Forensic medical supplies companies declare customs declarations through a single window. Unlike other exports of forensically inspected goods, this new forensic medical supplies export does not require origin inspection, and no electronic export ledger is required during customs declaration.
(1) For exported medical supplies for legal inspection, enterprises must report the purpose in the commodity name column of the customs declaration form and indicate whether it is for medical use. The detection reagent must indicate whether it is a new coronavirus. For testing purposes.
Warm reminder: If there are both medical supplies and non-medical supplies under the same HS code, whether it is for medical use should be determined based on the characteristics of the product itself, that is, the production and manufacturing standards.
(2) For the export of new coronavirus testing reagents, medical masks, medical protective clothing, and respiratory products listed in the “Announcement No. 5” of the three ministries and commissions (including those listed in subsequent adjustments to the announcement) For the five categories of medical supplies such as machines and infrared thermometers, when companies declare to the customs, they must provide a written or electronic statement and my country’s medical device product registration certificate. New coronavirus testing reagents must also provide an export sales certificate issued by the drug regulatory department.
(3) For other exported medical supplies subject to legal inspection, enterprises shall provide medical device product registration/filing certificates and quality and safety commitment statements when declaring to the customs. For those without relevant certificates and commitment statements, the customs will implement strict supervision.
<p�Therefore, if the outer packaging or test report or certificate of masks exported to the United States has the above content, it can be judged to be a medical mask.
Exporting non-medical masks to the United States does not fall within the scope of Announcement No. 5 of 2020, but companies should note that products must be registered with NIOSH before they can be marketed in the United States.
Export to EU
EU medical/non-medical masks They all need to affix the CE mark, but the applicable standards are different.
Medical masks are Class I devices in the EU. They are divided into Class I non-sterile and sterile. They must be in accordance with the EU Medical Device Directive 93/42/EEC (MDD) or The European Union Medical Device Regulation EU2017/745 (MDR) is affixed with the CE mark, and the corresponding standard is EN14683. If the outer packaging or test report or certificate of masks exported to the EU has the above content, it can be judged as a medical mask.
It should be noted that the EU adopts different measures according to the sterile/non-sterile status of the mask. According to the conformity assessment method, non-sterile medical mask companies only need to make a CE self-declaration of conformity and do not need to be certified by a notified body. After preparing the corresponding documents, test reports and other information, you can complete the declaration of conformity by yourself. Sterile medical masks must also be CE certified by an authorized notified body.
Non-medical masks exported to the EU are not medical devices, but must comply with the requirements of the EU Personal Protective Equipment Regulations EU2016/425 (PPE), and must be CE certified and issued a certificate by an authorized notified body. The corresponding standard is EN149.
Export to other countries and regions
For mask products exported to other countries and regions, please refer to Based on the Chinese standard testing certificate and registration information provided, there are three Chinese standards for medical masks, GB 19083-2010, YY 0469-2011, and YY/T 0969-2013. Masks produced using these three standards can be judged as medical. Face mask.
Standards for medical masks in China, the United States, and Europe
4. Distinguish through government registration and control information
Since medical masks are registered or controlled as medical devices in most countries or regions, Consumers can further distinguish through relevant registration control information. The following is an example analysis of three countries and regions: China, the United States, and Europe.
China
Medical masks are Class II medical devices in China. It is registered and managed by the provincial drug regulatory department, which can be queried through the medical device access number. The link is:
nmpa.gov/WS04/CL2590/
United States
Mask products that have been approved by the US FDA can be queried through its official website by checking the registration certificate number. The link is:
https://accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
In addition, according to the latest FDA policy, it is currently approved when certain conditions are met. For Chinese standard masks, the link to the authorized company is:
https://fda.gov/media/136663/download
European Union
Exports of medical masks to the EU can be inquired through the authorized notified body, including the EU Medical Device Directive 93/42 /EEC (MDD) authorized notified body inquiry address is: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
The inquiry address of the notified body authorized by the European Union Medical Device Regulation EU 2017/745 (MDR) is: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive. notifiedbody&dir_id=34</p
