Recently, with the rapid spread of new crown pneumonia abroad, the supply and demand of protective materials such as masks have become increasingly tight, but subject to the rigid requirements of technical regulations such as foreign testing and certification, the export of materials such as masks (especially masks produced by new enterprises) has been affected. In order to alleviate the tight supply and demand situation, recently, Europe and the United States and other major epidemic countries and regions have released temporary or emergency measures for the prevention of epidemic prevention materials to relax access requirements. The relevant measures collected are now reminded to trade and production enterprises as follows:
EU
The European Union's members published recommendations for compliance assessments and market surveillance procedures for medical devices and personal protective equipment (PPE) during the epidemic in the Official Journal of the European Union.
的 The main contents of the proposed emergency measures:
1. Product range: personal protective products (including masks, protective clothing, protective gloves, protective glasses), medical equipment (including surgical masks, medical examination gloves and some types of isolation clothing).
2. Implementation period: New crown pneumonia epidemic period
3. Minimum requirements: The product must ensure that it meets the key safety and health requirements of the corresponding regulations or directives.
4. Compliance assessment: Products that need to be notified by the notified body can be exported before completing the compliance assessment process (that is, before obtaining the CE mark), but it must be ensured that the certification work will continue to be completed. The notified body shall give priority to the compliance assessment of epidemic-related products; PPE (Personal Protective Equipment) products that do not adopt the PPE regulations and harmonized standards as technical requirements may also undergo emergency approval.
5. Procurement subject: Protective products restricted to the official or authorized agencies of EU member states may not have the CE mark, but they can only be used by medical personnel and cannot be sold on the local market.
6. Follow-up supervision: The relevant market surveillance agencies of EU member states will focus on spot-checking these products without the CE mark and evaluating them. If the evaluation finds that they do not meet the requirements, they will still be required to recall or take corrective measures to make them comply. .
European Commission recommendation: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2020.079.01.0001.01.ENG&toc=OJ:L:2020:079I:TOC #
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United States
The U.S. Department of Health and Social Services (HHS) announced the need for emergency use of medical supplies such as personal respiratory protective equipment and in vitro test kits during the outbreak of the new crown pneumonia epidemic. Manufacturers and strategic reserve agencies can make requests to the US Food and Drug Administration (FDA) to add their products to the Emergency Use Authorization (EUA).
The personal protective equipment is a disposable filter mask approved by NIOSH, which is used by medical institutions during the New Crown public health emergency. Allow manufacturers or strategic reserve agencies to apply to the FDA for expired respirators or respirators with unknown expiry dates that are beyond the EUA use authorization period (for example, N95 in state or local strategic inventory) to obtain emergency use authorization for respirators; FDA hopes The Strategic Reserve Agency notifies the FDA of expired respirators intended for use by e-mail, and specifies the manufacturer, model, and product expiration date (if there is no expiration date, provide the date of manufacture or receipt).
US Food and Drug Administration (FDA) "Emergency Use Authorization (EUA) Information and a List of All Current EUAs", click on the link: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory -and-policy-framework / emergency-use-authorization # 2019-ncov
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Korea
From March 18 to June 30, Korea ’s import masks and melt spray cloths for masks have been reduced from 10% and 8% tariff rates to 0 tariffs; South Korea ’s Customs and Food and Drug Safety Division has greatly relaxed the import clearance procedures for masks Thirty-four customs offices nationwide established a "Mask Import Quick Clearance Support Team" to closely support the Food and Drug Administration's import permits and customs clearance procedures. For the import of masks for relief, donation, and corporate payment of employees, the Korea Food and Drug Safety Administration recommends exemption. Confirmation of import conditions, customs also conduct customs clearance minimization to ensure rapid import.
解讀 Interpretation of measures:
The above measures in Europe and the United States and other countries have relaxed some necessary access conditions for the prevention and control of materials, but it is not difficult to see that these measures are emergency measures taken in the emergency situation of the new crown pneumonia epidemic or emergency recommendations to member countries, and they have not Relax the technical requirements in specific technical regulations, while the new measures emphasize the post-market supervision of spot checks and penalties.
Therefore, Chinese enterprises still need to strictly follow the technical requirements and compliance assessment requirements of the destination countries and regions to relax their production and operation. Through continuous strengthening of export product quality control, adhere to integrity management and compliance management, and continuously improve the international competitiveness of export products And influence, while helping the global fight against the epidemic, realize the sustainable and healthy development of the enterprise itself.
(Note: The entry conditions and technical standards listed in this article are compiled by domestic and foreign government agencies, professional websites, and news reports for reference only. Any dynamic adjustments are subject to the official interpretation and release of domestic and foreign competent authorities. )
