Importing Medical Equipment: The Practical Guide to Navigating Customs

If you frequently travel to the United States, whether for business or to visit family, you probably noticed that when it comes to shopping, the US has it all. There is an abundance of selection for everything from clothing, personal electronics, to medical equipment and even scented candles. Many of these products are not only more readily available in the US, but also less expensive compared to other countries. It’s no wonder then that discerning international shoppers prefer importing medical equipment, such as sleep apnea machines and portable oxygen concentrators, from the US rather than buying locally.

For these savvy shoppers, however, buying the medical device is just half the journey. There’s still the matter of transporting the equipment back to their home country. Unfortunately, this is where it can become complicated. Each country has its own unique customs regulations and requirements for importing medical supplies. However, in general, customs clearance involves passing an inspection and paying applicable taxes and fees.  

We’ve put together this guide to help CPAP and oxygen users navigate the murky waters of customs clearance. Click on each country to jump straight to it:

• Canada
• Australia
• New Zealand
• Netherlands
• United Kingdom
• Germany
• Malta
• Hong Kong
• Singapore
• Japan
• Taiwan

When importing medical equipment or any other goods from the US for personal use into Canada, it is crucial to note that these items are intended solely for personal consumption and not for any commercial, industrial, occupational, institutional, or similar purposes.

To ensure a smooth import process, it is essential to declare the items properly when bringing them into Canada. This declaration helps border services officers to determine the applicable duties and/or taxes on the goods. 

Your courier company may handle the shipment and account for it on your behalf. Alternatively, you can choose to self-account for your CPAP or oxygen supplies. This means you take responsibility for declaring the items and paying any applicable duties and/or taxes at a CBSA office that offers these services to the public. 

When consumers in Australia purchase medical equipment from the US, importers or licensed customs brokers act on their behalf to facilitate the customs clearance process. There are three types of declarations for imported goods:

1. Import Declaration (N10): This declaration is used when the imported medical equipment has a combined value exceeding AUD1,000 and is intended for personal use. The importer or their licensed customs broker must complete the Import Declaration, providing detailed information about the medical equipment, importer, transportation method, tariff classification, and customs value. All applicable duties, taxes, and charges must be paid before the medical equipment can be released.
2. Self-Assessed Clearance (SAC) Declaration: For medical equipment valued at AUD1,000 or less, the Self-Assessed Clearance Declaration is utilized. This declaration allows for duty-free and tax-free clearance for most items, excluding tobacco and alcohol.
3. Warehouse Declaration (N20): If the medical equipment is to be cleared into a licensed warehouse, a Warehouse Declaration is necessary.

It is also important to adhere to the guidelines established by the Therapeutic Goods Administration (TGA). The TGA monitors the safety, efficacy, and quality of medical devices to safeguard public health. 

The import of medical devices to New Zealand requires clearance by two government agencies: the New Zealand Customs Service (Customs) and the Ministry for Primary Industries (MPI). These agencies meticulously examine information about imported goods to ensure they pose no risk to the country and collect any applicable charges.

For arranging clearance of medical equipment for personal use, several options are available:

1. Border Clearance Included in Supplier Arrangement: Some online platform suppliers offer border clearance as part of their service. The goods, including medical equipment, will be delivered to your door through an express courier, and the supplier handles all necessary border clearance procedures.
2. Using an Agent: If returning from overseas with medical equipment, international moving companies may provide door-to-door service, including border clearance assistance. Make sure the company you choose offers border clearance support.
3. Clearing Goods at a Customs Counter: You can personally clear the medical equipment at a Customs counter when you arrive. A Customs officer, with MPI coordination, will assist in the clearance process.
4. Clearing Goods Online: If you frequently import medical goods for personal use, you can choose to clear the goods yourself online. Refer to the Registering to use TSW Fact Sheet for more information on the online clearance process. Trade Single Window (TSW) is an electronic channel for the cargo and excise industries to submit information to and receive responses from border agencies (Customs, Ministry for Primary Industries, Maritime NZ and Ministry of Health).

When importing medical supplies into the Netherlands from the United States or any other country outside the European Union (EU), import duties, value-added tax (VAT), and in certain cases, excise duty, consumption tax, or other fees may apply.

Import duties are charges imposed on imported goods, and they are collected by the Dutch Customs authorities on behalf of the EU. Products traded between EU member states do not incur import duties. However, VAT, also known as goods and services tax (GST), is still applicable.

If you’re looking to import oxygen concentrators or CPAP supplies to the UK, you’ll have to clear customs and pay customs duty and VAT. Medical equipment, as with other goods, are inspected to ensure they are neither banned nor restricted. 

In the UK, VAT is charged on all imported goods, including medical equipment, unless the goods are classified as gifts and their value is £39 or less. VAT is applied to both the value of the goods and additional costs including postage, packaging, and insurance.

When your package arrives in the UK, a parcel service such as Royal Mail or Parcelforce will help deliver the goods. They will contact you about any necessary payments for taxes, duties, or handling fees. Once payment has been received, they will deliver your parcel. 

If you do not pay the necessary fees within roughly 3 weeks, your imported goods risk being returned to the sender. It is essential, therefore, to factor in these potential costs and the need for prompt payment when shipping your sleep apnea supplies or oxygen machine to the UK.

Customs clearance for the import of medical equipment for personal use is a highly structured process in Germany. German customs will detain your shipment once it arrives in the country. Your courier service company, such as DHL or FedEx, will notify you of this. At this stage, you’ll need to declare the medical equipment to customs by providing detailed information about the items, including their value and purpose. 

Your shipment may be subject to VAT and customs duties, though items valued below 150 euros are typically free of customs duties. Moreover, duties that total less than 1 euro are typically not collected. Once all required fees have been paid, your oxygen supplies and CPAP equipment will be released and delivered to you.

Before importing medical equipment for personal use to Malta, it’s a good idea to familiarize yourself with Malta’s regulations for the import of medical devices. This typically involves contacting Malta’s Medicines Authority and the customs office. If an import license is necessary, you will need to apply for one. Once you meet all the required permissions and have the necessary paperwork, you can arrange for the transport of your product using a reliable international shipping company.

When your medical supplies arrive in Malta, they must clear customs before they can be delivered to your door. Typically this involves paying import duty and any applicable taxes.

The import of medical equipment to Hong Kong requires registering with the Customs and Excise Department and submitting an import/export declaration within 14 days of the importation or exportation. If import or export duties are required, they must be paid. Imported medical equipment must meet the regulations set out by the Department of Health’s Medical Equipment Division (MDD). The MDD oversees the efficacy, safety and quality of medical devices to protect the health and safety of the general public. 

One way to bypass all of this red tape is to bring your CPAP machine, mask, CPAP accessories or oxygen supplies with you as personal baggage into Hong Kong. Bear in mind if you choose to do so, the amount of medical equipment you bring must not exceed a “reasonable quantity for personal use.” 

When importing medical equipment to Singapore, you must register with Singapore Customs for a Central Registration (CR) number. After registration, you’ll need to submit an Inward Permit through TradeNet and pay Goods and Services Tax (GST) along with any other relevant duties. TradeNet is Singapore’s National Single Window for trade declaration. It integrates the functions of more than 35 permit issuing authorities into one single system, which simplifies the application and approval process for trade documentation.

Be sure to check out all the regulations set out by the Health Sciences Authority (HSA), Singapore’s national authority which establishes performance and safety requirements for the import of medical devices. If you choose instead to simply bring your sleep apnea or oxygen equipment with you while traveling to Singapore, you’ll need to apply for an approval from the HSA at least 10 business days before your expected arrival date. You’ll need to submit an application, which can be done online. You are not required to declare your medical supplies once you arrive in Singapore but make sure you have all the proper documentation for customs. 

Like the other countries we’ve mentioned, Japan has regulations regarding the quantity of medication and medical devices that can be brought into the country for personal use. Each person is limited to one medical device and a month’s supply of prescription drugs. If you need to bring more than the restricted amount for personal use, and you are arriving at Narita, Kansai, or Naha International Airport, be sure to contact the respective Regional Bureau of Health and Welfare at each airport before your departure for Japan.  

If you decide to ship your CPAP or oxygen equipment to Japan, you have a couple options. You can use an international courier such as FedEx, UPS etc. or you can use parcel post/international mail. Using an international courier simplifies the process because a customs broker will handle customs clearance for you and advance any duty payments. If you decide to send your package using international mail, Japan Post Service (JPS) will deliver the goods to you once it arrives in Japan. 

Please note that duty and custom fees are still applicable when shipping via parcel post. JPS sends a Notice of Assessment to the recipient who will need to pay the duty and customs fees before they can receive the package. The fees can be paid at the post office or upon delivery of the goods, depending on the total duty amount. 

If you’re importing medical equipment to Taiwan for personal use, it’s important to keep in mind that there is a limit of one device per person. However, Taiwan’s Food and Drug Administration (TFDA) does permit more than one device to be imported if you require access to multiple devices at different locations. Like Singapore’s HSA, the TFDA requires you to submit an application* prior to importing your medical device. There is also, unfortunately, a $2000 NTD (New Taiwan Dollar) processing fee.

*We were unable to locate an English application form on the TFDA website. Additionally, all the information we could find on the TFDA website regarding importing medical equipment to Taiwan for personal use was in Mandarin. 

Navigating the endless bureaucracy of customs clearance can be challenging. However, the correct information and ample preparation will help simplify the shipping/import process and save you some time. We recommend, if possible, that you bring your CPAP machine, sleep apnea masks, portable oxygen concentrator, and other oxygen supplies with you when returning to your country, rather than shipping them. You shouldn’t encounter any issues with customs as long as you do not exceed the permitted quantity for personal use medical devices. It is also a good idea to have your prescription available for customs inspection.

If, for whatever reason, you must ship your equipment, we recommend contacting your local customs office or reaching out to a customs broker prior to shipping. They can ensure you have the proper documentation for smooth customs clearance. While we aren’t experts in customs clearance, we are certainly experts in sleep apnea and home oxygen therapy. Don’t hesitate to contact our medical staff today and get answers to your CPAP and oxygen questions!