Global Import Regulations for

United Arab Emirates

No Restrictions, but Public Health Institutions Cannot Buy

Source: Report from CS Post (via E-Mail), 16 April 2003

Are there special restrictions or tariffs that apply to used medical equipment?

There are no special restrictions or tariffs that apply to used equipment that do not apply to new equipment. The same customs charges of 5 percent is levied on both new and used equipment.

If a manufacturer or its agent has registered a medical device in the country, can a third party legally import the same device in used/refurbished condition without the used device being subject to new safety inspections, etc.?

A third party can import used medical equipment even if its agent has registered the device in the United Arab Emirates (UAE). Yet this imposes after sale maintenance issues especially for high-tech equipment, where only registered agents have after sale maintenance capabilities and registered agents might not accept to provide maintenance. At the same time if import documents specify a brand that has an agent in the UAE, only the agent can clear on these items with Customs Department. With that said, the usual practice has been not to specify the brand/manufacturer, rather the name of supplier. Neither new nor used/refurbished medical equipment are subject to safety inspection by the local authorities.

Can public health institutions buy used or refurbished medical devise?

Government regulations does not permit Public health institutions to buy used or refurbished medical equipment.

Is there a market for used or refurbished medical devices?

The government in the UAE is the main healthcare provider. Government healthcare services account for 80 percent of the market. Only 20 percent of the market for healthcare services is supplied by the private clinics and hospitals. The majority of the bigger private clinics and hospitals prefer and can afford new equipment. Therefore, the market for refurbished medical equipment/devices is the UAE is rather limited.

If there is a market, what types of used or refurbished medical equipment are in the greatest demand?

As stated above, the market is limited to smaller private clinics and hospitals. These usually buy refurbished imaging, diagnostic, radiology and ultrasound equipment. Yet, although the market for refurbished medical equipment is limited in the UAE, there seem to be a market of the same for re-export to neighboring countries.

United Kingdom

General Market Condition: No Restrictions, but CE Mark is Required

See also entry for the European Union.

Source: Report from CS Post (via E-Mail), 22 March 2002

The United Kingdom has a growing requirement and interest for used medical equipment, across all sectors. The majority of such purchases are made by hospitals that are part of the United Kingdom’s government-funded National Health Service (NHS). Such pre-owned equipment is subject to the same import duties and regulations as new devices.

The U.K. medical equipment market is driven by the NHS—the United Kingdom’s universal, publicly funded healthcare system—which accounts for about 85 percent of total U.K. healthcare provision. As such, the NHS accounts for the majority of medical equipment purchases in the $3-billion U.K. market.

In the past, NHS purchases of used medical equipment have focused on radiology equipment such as X-ray machines and scanners. Currently, NHS demand covers all sectors: large surgical equipment, radiology equipment and other medical diagnostic equipment. Given the NHS’ recent moves to improve the standard of care for cancer patients, the market for all pre-owned diagnostic medical equipment should increase.

The majority of used medical equipment procured by the NHS is purchased by individual hospital trusts, which are regional groupings of the 1,578 NHS hospitals. Contact information for these trusts can be found at www.doh.gov.uk.

The NHS also has a central purchasing organization—the NHS purchasing and supplies agency—(www.pasa.doh.gov.uk) that influences more than half of the NHS’ total spend on supplies. Although NHS hospitals are not required to purchase from this agency, over 98 percent of NHS trusts place all, most, or some of their business with the organization. Contacts at this agency report that in the past they have done little procurement of used medical equipment but have recently been approached by a U.S. company who sells pre-owned medical equipment and was very interested in exploring similar opportunities. Senior buyers at PASA told us that they were there certainly was an important niche for pre-owned medical equipment in the UK market. The NHS purchasing and supplies agency can be reached on 44-1244-586-859.

In addition, over the next three years, the NHS will be purchasing $150-million worth of new cancer equipment—including diagnostic equipment, linear accelerators, and breast screening equipment—for over 200 hospitals. The purchases will be funded by the U.K. National Lottery’s New Opportunities Fund (NOF), contact information for which can be found on the website www.noh.org.uk.

Private sector procurement of medical equipment is financed by the individual organization or hospital group. There are currently 229 private hospitals in the United Kingdom, and these organizations purchase very limited amounts of used equipment, if any at all. Information on the U.K. private healthcare sector can be found on the website www.iha.org.uk.

Any used or refurbished medical equipment sold in the U.K. market faces the same restrictions and regulations as new equipment. As with a new medical device, a used or refurbished medical device must obtain a CE mark that enables the product to be marketed anywhere within the EU. To obtain a CE mark, full compliance with the appropriate EU directive must be achieved. The three main EU medical devices directives are the EU Medical Devices Directive, the Active Implantable Medical Devices Directive, and the EU In-Vitro Diagnostic Medical Devices Directive (to be fully implemented in December 2005).

If a product has obtained a CE mark and is then refurbished, no re-registering is required if the product is refurbished with original equivalent parts (i.e. parts must meet manufacturer specifications). If significant alterations occur, previous regulatory approval could be invalidated.

Within the United Kingdom, the U.K. Medical Devices Agency (MDA) enforces regulations and deals with inquiries concerning compliance to the EU directives. Information about the MDA and full descriptions of the EU directives can be obtained on the Webster www.mca.gov.uk

Used or refurbished medical equipment is subject to the same import duties as new devices. The majority of medical equipment is classified into one of two categories in the Harmonized Tariff Schedule (HTS): HTS 9018 (medical, surgical, and dental instruments and apparatus) and HTS 9402 (medical, surgical, and dental furniture). New or used medical equipment classified under HTS 9018 and 9402 can be imported into the United Kingdom duty-free. A 17.5 percent value-added tax (VAT) is levied on the CIF value of the products (the value of the product, plus carriage, insurance, and freight).