As a result, demand for masks will also surge among some overseas airlines and high-traffic public institutions. These businesses/organizations also happen to be active business buyers on Amazon Business. If you are selling protective products on Amazon Business, consider stocking up so you can do your part in this "protection effort" in a timely way. At the same time, all sellers should also ensure compliance on their own. Masks are designed and manufactured according to corresponding standards in developed countries such as Europe, the United States, and Japan, and are mainly divided into three levels based on the filtration efficiency for microparticles (0.3μm) and the mask material.

As a type of lab-science and healthcare product on Amazon Business, masks have consistently been in demand. In addition to this type of product, Amazon Business also has other bestselling categories worth exploring. Today, we’ll take you through the new blue-ocean categories and the related product compliance requirements in Amazon Business’s major bestselling categories one by one. With this guide in hand, you can build a more sustainable business in the new year!

There are many categories of scientific and medical devices that can be sold across Amazon Marketplace sites, including contact lens care products, blood pressure monitors, massagers, adhesive bandages, and medical gauze. However, according to the laws and regulations of each destination market and Amazon policies, there are special restrictions on the sale and storage of medical devices. Next, let’s walk you through the specific requirements for selling medical devices in each Amazon Marketplace.

Approved medical device products include medical devices, eyeglass frames, tanning devices, otoscopes, ionizing or ionic bracelets, and personal sound amplification products (PSAPs) that are approved by the Food and Drug Administration (FDA) for over-the-counter sale, are not subject to other restrictions, and have appropriate descriptions and labeling.

Other restricted specialty medical device products, Amazon treats products that require a prescription or use under the supervision or guidance of a medical professional as a “restricted” product, and sellers can only sell such products to healthcare buyers who have an Amazon Business Marketplace account and have obtained the appropriate license. Chinese sellers can also apply to join this program if they import through a US entity registered with the FDA. FDA registration information in selected states will determine a seller’s authorization to sell professional healthcare products to professional healthcare customers in those states. If you're interested in participating in the Specialty Healthcare Supplies Program, get more information at 可以发邮件给prohealthcare@amazon.com.

After participating in the program, sellers will be approved to sell products such as cancer tests, antibacterial water, contact lenses, including cosmetic and corrective lenses, continuous positive airway pressure (CPAP, VPAP, BiPAP) devices and certain accessories, prescription dental devices, electronic muscle stimulation (EMS) devices and their accessories, defibrillators (unless approved for over-the-counter sale), insulin pumps, mandibular advancement devices, oral polishing abrasives, and resin tooth adhesives.

As a basic guideline, all categories of medical devices can be sold on the Amazon Japan site if they are labeled accordingly in accordance with the requirements of the Drugs and Medical Devices Act (*) and other laws, regulations, administrative interpretations, and guidelines (hereinafter collectively referred to as “laws”).

Example – medical devices approved for sale:
In addition to obtaining approval to sell products, sellers planning to sell highly controlled medical devices or specific maintenance management medical devices also need permission from the local county governor, while sellers planning to sell controlled medical devices (excluding specific maintenance management medical devices) need to notify the local county governor.

Prohibited products:
• Unapproved products covered by the Law Concerning Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, and Other Related Matters.
• Products that require a prescription or that must be purchased under the supervision or guidance of a medical professional and used in accordance with notices from legal or regulatory authorities.
• Specific maintenance management medical devices, which require specific knowledge or skills for maintenance management, such as routine inspection and repair. These products cannot be sold through FBA, regardless of their tier.
• It is prohibited to act as an agent for personal imports, list products using similar methods, or directly ship imported products to buyers (a seller in Japan receives an order, and another seller outside Japan directly ships the product to the buyer).
• If you want to use Fulfillment by Amazon (FBA), some products that require a designated administrator (specially controlled or highly controlled medical devices) cannot be sold.

If you want to sell highly controlled medical devices, you need to prepare the following for product compliance:
▼ Confirm all basic product information with the factory in advance, such as the name of the market authorization holder, the name of the medical device, the medical device classification, the corresponding medical device certification (approval) number, whether it is a professional medical device, and whether special maintenance is required.
▼ After you finish uploading your product selection, please submit the relevant documents to cops-jp-md-seller@amazon.com, such as the Medical Device Information Sheet, along with the corresponding medical device supporting documents (as defined under the Pharmaceuticals and Medical Devices Act) and product packaging images.
▼Prevent illegal or misleading descriptions, for example, terms such as “thermometer” cannot be used on detail pages for non-medical devices or unauthorized products.

Permitted medical device products:
Some medical devices do not require a prescription, physician, or professional guidance; are lawfully manufactured; have appropriate descriptions and labels; and are not subject to other restrictions, for example

Industrial products (MRO) stands for Maintenance, Repair, and Operations, and the global MRO market is expected to reach $600 billion in 2020. So, which categories in MRO are areas where Chinese manufacturing has an advantage and where the destination market has relatively low compliance barriers?Below, we summarize a few niche categories, as well as the sales standards and customer usage habits for these products.

Automotive and Maintenance
This category includes automotive and vehicle products, parts, and vehicle operation tools. Among the products where Chinese manufacturing is more mature, tire inflator accessories such as inflators, various quick-inflation connectors, pressure gauge accessories, and air hoses (usually mainly nitrile rubber and PVC hoses) are categories with relatively low compliance barriers in the destination market. The basic requirement these products usually need to meet is pressure resistance, and for automotive inflators, the usual pressure requirement is around 100 psi (7 kg), which is very easy for parts factories to meet. Taking the US market as an example, auto repair is a very typical MRO industry. Most inflation accessories are also consumables. As long as the quality is solid, it’s very easy to gain stable B2B customers.

Material Handling:
A niche category with strong blue-ocean potential, where most buyers are business customers. Material handling refers to equipment used to efficiently handle, store, or transport items. Trolleys are widely used in various warehouses and restaurants, and cart wheels are consumables that need to be replaced frequently. Ladders and shelves are essential items in warehouses and supermarkets. Strapping is in very high demand across various transportation scenarios.
Recommended product 1: Wheels
The wheels mentioned here are not tires used on cars or bicycles, but casters and fixed wheels that need to be replaced frequently on products such as hand trucks, warehouse carts, and cleaning carts. These wheels can be divided by structure into pneumatic wheels, semi-pneumatic wheels, and solid wheels; by material, they are mainly made of nitrile rubber, polypropylene, and polyethylene, while polyurethane is used when especially high wear resistance is needed. There are no compliance restrictions for entering major destination-country markets. Customers usually focus on wheel durability, and the key parameters that determine durability are tire material (which determines whether it is wear-resistant and pressure-resistant) and structure (which determines suitability). There are some industrial standards for exporting to European and American markets, and factories can refer to standards such as ANSI ICWM and EN 12532 when developing products.

Recommended Product 2: hand trucks
Trolleys, especially small folding trolleys, are very popular in the Japanese market. You may be wondering why?Because Japan is a rapidly aging society, many people over the age of 70 still work in various service settings. Lightweight and portable trolleys can help ordinary consumers and workers in various industries transport things more easily. These products are usually made of aluminum tubes with small swivel casters, and while the cost is low, the design is very important. Two points are worth noting: the product design should try to avoid patent infringement; second, consider the product's load-bearing requirements. Based on industry experience, we generally add a safety factor of 1–2 times to the claimed load capacity to help ensure product safety.

Office & Break Room broadly refers to the materials needed to carry out various office tasks and meet daily office needs, including office furniture, cleaning products, stationery, file organization supplies, printing and copying supplies, and consumables. These products in the destination country market are mainly subject to certain industry technical specifications and functional design requirements.

Office desks and chairs
The main standard that applies to office desks and chairs in the US and European markets is the ANSI/BIFMA product design and testing standard. This standard sets requirements for key parameters such as load-bearing capacity, stability, and durability, and provides detailed test methods and acceptance criteria. For example, office chairs are usually divided into three categories based on their function: Tilting Chair, Fixed Chair, and Fixed Seat. The testing standards also vary slightly depending on the type of office chair.

In addition to BIFMA requirements, if office furniture uses non-solid wood boards such as particleboard and fiberboard, CARB certification from California is required, mainly for formaldehyde emission requirements.

Clocks and time recording systems
This category is relatively less competitive and mainly includes products such as clocks, timers, and time clocks. This type of product is subject to mandatory requirements in almost every destination market, and some electronic clocks need to comply with FCC Part 15 requirements. However, designing and producing these products requires a certain level of expertise. Corresponding technical standards can refer to UL 826, UL863 and other technical parameter requirements for products.

The product selection for electronic technology covers laptops, consumer electronics, and wireless electronics. And these products are also the most prone to safety complaints and accidents. In addition, as the European and US markets place increasing importance on the quality of electronics products, what we especially want to remind you here about is the compliance requirements for electronics products in each destination market.

The first thing to note is FCC mandatory certification, which applies to electronic equipment such as WiFi devices and two-way radios. As a manufacturer or importer, you must ensure that your products are tested in a laboratory in accordance with regulatory requirements and meet the relevant technical standards. The FCC has the authority to require manufacturers to provide equipment samples and test data. The product requires a responsible party in the US . If not, you need to apply for an FCC ID as an alternative certification method. The responsible party must issue a Declaration of Conformity.

Electronic technology products sold in the EU market must have the “CE” mark. According to the new CE Directive implemented on January 3, 2013, electrical products meet the requirements of the following directives:
· Electromagnetic Compatibility Directive (EMC)
· Radio Equipment Directive (RED)
· Low Voltage Directive (LVD)

MIC certification: Radio frequency and telecommunications products sold in Japan, such as laptop computers, APs, routers, landline phones, cell phones, LTE-to-Wi-Fi devices, and Bluetooth headsets, require MIC certification as long as they are sold in Japan. In addition, the MIC certification mark and the issued number must be affixed to or printed on the certified product. Direct sales in Japan without this certification are illegal and will be severely punished.

PSE certification: is a market access system implemented by the Japanese government for electrical and electronic products, and it is an important part of Japan’s Electrical Appliance and Material Safety Law (DENAN). On April 1, 2001, Japan revised the DENAN Law, which is administered by METI (Japan's Ministry of Economy, Trade and Industry). METI does not directly issue certificates, but instead authorizes third-party certification bodies to conduct product conformity assessment testing and issue certificates. PSE certification is a mandatory safety certification in Japan used to prove that electromechanical and electronic products have passed safety standards testing under Japan’s Electrical Appliance and Material Safety Act (DENAN Law) or international IEC standards. Japan's DENTORL Act (Electrical Equipment and Material Control Act) stipulates that 498 products must pass safety certification when entering the Japanese market. Among them, 165 Class A products should obtain a diamond-shaped PSE mark, and 333 Class B products should obtain a round PSE mark. Among them, 116 products that are more likely to cause accidents such as electric shock and fire and pose greater risks are classified as “specific electrical products”—called “Class A electrical products,” such as chargers and adapters; the remaining 341 products that pose lower risks are classified as “non-specific electrical products”—called “Class B electrical products,” and most large and small household appliances, lighting products, and lithium batteries fall into Class B.

Food storage and transport
These products include tools and supplies that help keep kitchens clean and safe, and properly store, process, and transport food. Various storage racks, coffee machines, grinders, and knives all fall into this category. These products are for both business buyers and individual consumers. For most products in this category, we have only one requirement: “food grade”!When looking for suppliers, sellers must look for products that have FDA or NSF certification in order to successfully enter the destination market for sale.

Hotel bathroom products
The main difference between hotel bathroom products and household bathroom products is that such products, such as showers, faucets, etc., pay more attention to functionality and durability, and are more common in appearance compared to household bathroom products. However, whether for domestic or commercial use, all bathroom products in the US are required to comply with two regulations:
1）Low Lead Act, which means that for all water fittings and pipeline valve products used in water supply systems, the weighted average lead content of the product surfaces that directly contact water must not exceed 0.25%.
2) Water efficiency law. Although this law is currently enforced only in a few states in the US, given the US-wide focus on energy efficiency and environmental protection, a water efficiency law like this will sooner or later be implemented nationwide. Specific water efficiency requirements can be found in the table below

The requirements for product compliance can’t be listed one by one. If you’d like to learn more, you can search from different angles on Seller Central’s help pages.

When you enter a specific type of “product keyword” or “destination country laws and regulations”, you will get the corresponding reference content or Amazon’s compliance requirements for a certain type of product, as shown in the example below: