Contents:
1/ Medical and epidemic prevention hot supplies and compliance guidelines 2/ Four Don'ts for Product Creation 3/ Self-check basic qualifications

As overseas demand for epidemic prevention and control intensifies and enterprises need to resume work and resume production, consumers, especially enterprises and institutions, have a large demand for protective equipment such as masks, protective clothing, and disinfectant. Especially when the global epidemic situation is still uncertain, the fight against the epidemic may become a “protracted war.”

In order to more effectively support the international community's joint response to this global public health crisis, the Ministry of Commerce also recently issued the latest announcement on export quality supervision of epidemic prevention materials.

In order to continue fighting the novel coronavirus pneumonia epidemic, Amazon will prioritize the supply of key medical supplies to hospitals and government agencies. Currently, many hospitals and government agencies registered through Amazon Business can apply for procurement through Covid-19 Supplies (COVID-19 Prevention Supplies Hotline). At the same time, Amazon will adopt strict standards to review seller qualifications and product qualifications.

Amazon Global Stores hereby reminds all sellers that in order to sell such products, they must strictly abide by China's export control policies, overseas market compliance certification standards, and Amazon sales policies. Therefore, while contributing to the global fight against the epidemic, enterprises also need to adjust production, export and sales application plans according to corresponding standards and specifications.

Next, we will provide you with a detailed explanation of the guidelines and compliance policies for the sale of high-demand medical and epidemic prevention supplies.

According to the purpose of the product, medical and epidemic prevention supplies that are in high demand at this stage can be divided into three categories: medical protection, “elimination”, and medical testing and testing instruments and equipment.

Masks, protective gloves, protective clothing, etc. are medical protective equipment that can physically block and protect the human body.

Masks have a certain filtering effect on the air entering the lungs, can block harmful gases, odors, and droplets from entering and leaving the wearer's mouth and nose, and can effectively inhibit the spread of virus particles. The four most common and most in-demand masks during the pandemic are N95 masks, KN95 masks, medical surgical masks, and disposable medical masks. The selection of oily particulate matter media used in each standard of these masks is not exactly the same. Sellers must understand the implementation standards and category characteristics of masks when producing and selecting masks to ensure the safety and health of users.

▼ Product name: N95 mask
▼ Product description: In line with NOISH certification, it is divided into medical protective N95 and non-medical protective N95 masks with the function of medical surgical masks. Good sealing performance, 95% filtration effect on 0.3 micro particles; has a waterproof layer

▼ Product name: KN95 mask
▼Product description: It is a non-medical protective mask with good sealing performance, conforms to China's GB 2626 mandatory standards, and has a filtration efficiency of ≥ 95% for non-oily particulate matter.

▼ Product name: medical surgical mask
▼ Product description: There is a special filter layer; there is a waterproof layer

▼ Product name: disposable medical mask
▼ Product description: High efficiency barrier, smooth breathing, fresh, three-dimensional, breathable and comfortable; 3 layers of protection: non-woven outer layer + filter paper layer + skin-friendly non-woven inner layer; disposable design, effective against bacteria, dust and air pollution; soft and comfortable ear hooks, not easy to fall off, no need to adjust during work

Protective gloves are mainly aimed at preventing hands from being dirty or infected by microorganisms, and can also prevent the spread of microorganisms already present on the skin or hands. According to different materials, protective gloves can be divided into nitrile gloves, PVC gloves, latex gloves, PE gloves, etc., and can be divided into medical grade and non-medical grade according to quality level and use: the use of medical protective gloves in hospitals, clinics and other fields can effectively reduce viral cross-infection between doctors and patients; non-medical protective gloves are also widely used in homes, restaurants, etc.

▼ Product Name: Medical disposable nitrile gloves
▼ Product description: Good elasticity, strong stretch, fits the hand skin well, has excellent comfort, acid and alkali resistance, oil resistance, antistatic, and non-allergenic

▼ Product name: PVC gloves
▼Product description: Easy to wear, good breathability

▼ Product name: latex gloves
▼ Product description: Elastic, strong adhesion to skin, contains collagen, may cause allergies

▼ Product name: disposable PE gloves
▼ Product description: Low price, poor elasticity, easy to break, can touch food, non-toxic

The function of protective clothing is to isolate germs, harmful ultrafine dust, acid-alkaline solutions, electromagnetic radiation, etc., to ensure the safety of personnel and keep the environment clean. Demand for medical protective clothing has remained high during the COVID-19 pandemic. It is an urgent medical supply needed by overseas medical personnel and people entering specific medical and health care areas. Among them, the main materials of medical protective clothing are chemical fibers, rubber and plastics, which are Class II medical devices and have higher product compliance requirements.

▼ Product name: medical protective clothing
▼ Product description: Protection, comfort, physical and mechanical properties, disinfection resistance, prevention of shrinkage, non-flammability, non-toxic and non-irritating, harmless to skin

▼ Product name: medical goggles
▼ Product description: It is mostly made of polycarbonate (PC). Polycarbonate PC has the advantages of high transparency, good impact resistance, not easy to break, can withstand steam, cleaning agents, heating, and high-dose radiation disinfection, and does not turn yellow or deteriorate in physical properties

▼ Product name: disposable medical isolation shoe cover
▼Product description: Using non-woven fabric as raw material, disposable, good insulation, waterproof and breathable, high strength

▼ Medical masks: They must be registered with the US FDA. Common medical masks are Class II medical devices in the FDA medical device classification.
▼ Non-medical personal protective products: You do not need to pass FDA (Food and Drug Administration) registration license, but you must obtain US NIOSH testing certification, that is, the National Institute for Occupational Safety and Health Certified by the Institute of Safety and Health.

▼ Medical masks: They are medical devices in the EU. The EU standard implemented is EN14683. According to the standard, medical masks are divided into three categories: TypeIA/TYPEII/TYPEIIR. Type IA is used for patients and other groups during the epidemic, and TYPEⅡ and TYPEⅡ R are used for healthcare workers, and need to meet the requirements of the European Union (EU) 2017/745 (new medical device MDR). Medical masks are Class I devices in the European Union and are divided into two types: Class I sterile and Class I sterile.
▼ Non-medical personal protective products: They are non-medical devices in the EU. The EU standard implemented is EN149. According to the standard, masks are divided into three categories: FFP1/FFP2/FFP3, and must meet the requirements of the European Union (EU) 2016/425 Personal Protective Equipment Directive (PPE). The mainstream protective masks are FFP2/FFP3.

The export of personal protective equipment must be registered by the Australian TGA (Therapeutic Goods Administration) and complies with the standard specification: AS/NZS 1716:2012, which is the standard for respiratory protection devices in Australia and New Zealand. The TGA is Australia's supervisory authority for therapeutic products, including medicines, medical devices, gene technology, and blood products. Medical devices in Australia are classified as Class I, IIs and Im, IIa, IIb, and Class III. The classification of products is almost consistent with the EU classification. If the product has obtained the CE mark, the product category can be classified according to CE.

Sanitizers mainly refer to hand sanitizers, hand sanitizers, disinfectants, etc. They use chemical components to kill microorganisms such as bacteria and viruses, and can effectively prevent further transmission of the virus. They are essential products for personal home prevention and disinfection of various public places during the epidemic. According to the US Centers for Disease Control and Prevention (CDC), hand cleaning is one of the most important steps to avoid getting sick and prevent the spread of infectious diseases, and hand sanitizers must contain at least 60% alcohol. Disinfectants are mainly used to disinfect professional medical facilities or places such as schools, homes, offices, travel, and parks.

▼ Product name: disposable hand sanitizer
▼ Product description: 99.99% effective; moisturizing function, suitable for frequent use, gentle formula does not contain irritating ingredients; different volumes, can be packaged at home or separately, easy to carry; no washing

▼ Product name: Disinfectant alcohol swamps/wipes
▼ Product description: Alcohol wipes are individually wrapped in tin foil to keep them sterile and moist; 75% alcohol cotton balls can effectively clean touch surfaces to remove dust, moisture, and unnecessary small particles; very convenient, easy to use and compact to carry

Hand sanitizers are over-the-counter (OTC, over-the-counter) topical disinfectants. Like anti-dandruff shampoo, fluoride toothpaste, sunscreen, etc., they are regulated by the FDA. OTC drugs have a completely different regulatory system from prescription drugs, called “OTC Monographs” (OTC Monographs). OTC monographs are equivalent to active substance standards.

According to the EU ECHA supervisory authority, the EU has mandatory strict controls on disinfectant products. All disinfection products exported to the EU market must meet the compliance requirements of Regulation (EU) 528/2012 (Biocidal Products Regulation (BPR)) at the EU level, that is, the EU biocidal regulations. In addition, if some member states have additional requirements for disinfection product compliance, they also need to communicate well with target countries to meet the regulatory requirements of specific member countries.

An effective way to prevent COVID-19 is early detection and early isolation. This also keeps the demand for testing instruments and equipment such as infrared thermometers high. Infrared thermometers can quickly and accurately measure human body temperature to help medical personnel and quarantine personnel identify people with fever as soon as possible.

▼Product Name: Non-contact infrared electronic thermometer
▼ Product description: No laser spots, no potential damage to eyes, no need to touch human skin, avoid cross-infection, easy to carry

Medical testing instruments and equipment, including infrared thermometers, are a type of medical device. Entering the US market requires FDA certification, and exports to the EU also require CE certification.
⚠ The above is a summary of some compliance requirements when exporting high-demand medical and epidemic prevention supplies. The information is for reference only. Due to changes in laws and regulations, the above information may be delayed, omitted, or erroneous. Please consult and confirm accordingly before making a decision or taking action. For specific procedures and more information, sellers are requested to learn more through official channels such as calling the 12360 Customs Service Hotline.

2. Check your basic qualifications

We have also prepared a self-inspection form for all sellers before applying for sale. We recommend that you first check your qualifications according to the following six points and carefully read the relevant regulations of each country and the relevant regulations of Amazon Seller Central.

Amazon will continue to prioritize delivery of products that people currently urgently need, and will also deliver slightly lower priority products as soon as possible. At the same time, it will also continue to strictly comply with the epidemic. For medical protection products, the US FDA and the European Union have both opened a green channel to simplify the process and shorten registration and certification time to bring these products to the market as soon as possible, but this does not mean that it is not regulated or controlled. All sellers who want to apply for the export and sale of medical and epidemic prevention products must keep up with policy changes, follow the news, do a good job in product compliance, and better contribute China's strength to the global fight against the epidemic. Observe various protective measures, such as “maintaining social distance”, etc., in accordance with the guidance of the health department, to ensure the safety and health of employees.