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Did You Know?

Your Sub-Licensed GE Software Options on your Diagnostic Imaging Equipment May NOT be Transferable?

Find out what this could mean for you here.

OMB receives CMS rules overhauling Medicaid

The CMS has sent a sweeping finalized rule that will overhaul the managedMedicaid program to the Office of Management and Budget for review. The 653-page proposed version of the rule suggested the biggest changes in Medicaid managed-care regulations in more than a decade. It would cap insurer profits, require states to more rigorously supervise the adequacy of plans’ provider networks, encourage states to establish quality rating systems for plans, allow more behavioral healthcare in institutional settings and encourage the growth of managed long-term care.  
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IAMERS Reception at ECR in Vienna 4 March 2016

ECR Brochure

I Was At The IAMERS RSNA Reception, Were You?

By: Wayne Webster, Proactics Consulting

If you wanted to see and be seen at the RSNA it wasn’t going to happen on the exhibit floor. You needed to be at the IAMERS reception on Monday evening. Each year IAMERS holds its biggest event of the year at RSNA. The Intercontinental Hotel Ballroom is the venue and it is standing room only. There are no buses to transport party goers to a free event that sales people struggle to get people to attend. Not the IAMERS reception. It’s open to members only. If you aren’t a member it’s going to cost a pretty penny for a ticket.

What’s the draw? It’s simple, this is the one time of the year those good enough to be IAMERS members can meet in one place and rekindle and start new profitable relationships. Diana Upton, President of IAMERS arranges the venue, the munchies and the cash bar for the members and the party is on.

This year it was packed, starting at 7 PM there was a line out the door waiting to enter the ballroom. Why do they wait in line and those who aren’t members beg to get in? Because in this world you get what you pay for. If you’re an IAMERS member you belong to an exclusive group of highly qualified medical imaging companies that are making an impact in pre-owned medical imaging equipment around the globe. The best place for these fine companies to meet and get to know each other better is at the RSNA IAMERS reception.

Want to attend next year’s reception? Just remember what they say at American Express, “Membership has its privileges.” Call IAMERS and find out if you have what it takes to qualify for membership.

IAMERS Barcelona Meeting

We had a great time in Barcelona and hope you did too.
Here are a few images from the meeting. Do you have any to share?

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Spectral Imaging Brings New Light to CT

The ability to perform image acquisition and processing at multiple energy levels is improving visualization for computed tomography and enhancing patient care

Read more here.

Featured Member Agito Medical

Meet out featured member Agito Medical.

Featured Member Agito

Earth may hold more helium than we thought

Don’t mourn the loss of your humorously high-pitched voices quite yet. Despite years of warnings from scientists that Earth’s supply of helium is quickly running out, the results of a study announced Wednesday in Prague show there could still be large deposits of the element hidden underground, the Guardian reports.

Read more here.

Pre-owned Medical Importation – by Country

Used and Refurbished Medical Equipment

Australia: Importation is allowed however there is not a strong demand.

Austria: Importation of used and refurbished medical equipment is permitted, but the products must meet the European certification requirements and be CE marked. There is not a strong market for such equipment. 

Brazil: Importation is not allowed. Refurbishment must be done locally on equipment that was imported as new. 

Bulgaria: Importation of used and refurbished medical equipment is permitted, but the products must meet local requirements listed on the web site of the Bulgarian Drug Agency (www.bda.bg) and should comply with the European certification requirements and CE mark. An important requirement is contracts to be secured with servicing and maintenance.

Canada: Importation is allowed, however, there are many regulations they must comply with and the demand is not high. There may be some success with individual hospitals and private clinics.  

Chile: Importation of used/refurbished medical equipment is allowed, however, market potential is limited and maintenance and technical service may be an issue.

China: No importation of used and refurbished medical equipment is allowed.

Colombia: Importation is allowed but must meet a significant amount of requirements.

Croatia: Used and Refurbished Medical Equipment can be imported to Croatia and CE mark has to be obtained. Due to the lack of market opportunities, this market segment is mostly attractive to the products with CE within EU.

Denmark: In general, there are no specific laws prohibiting the import of used medical equipment other than general ones regarding health, safety and environmental issues.  However, the products must meet the European certification requirements and be CE-marked. There is not a strong market for such equipment.

Ecuador: Importation is only allowed in private clinics and hospitals, estimated to occupy 30% of the market. Any used equipment must be refurbished and have at least a one year warranty.

Egypt: No importation of used and refurbished medical equipment is allowed.

France: Importation of used and refurbished medical equipment is permitted, but the products must meet the European certification requirements and be CE marked. There is not a strong market for such equipment.

Germany: Importation is allowed and there is market potential. 

Guatemala: Importation of used/refurbished medical equipment is allowed and there are no restrictions. It is preferable that the equipment has FDA or CE certifications. 

Hong KongThe same restrictions and tariffs are applied to used and new medical equipment. Hong Kong agents and distributors in this industry prefer to source the ‘newest and latest’ equipment. There is limited market for used and refurbished medical equipment. Public hospitals, private hospitals and health institutes in Hong Kong do not buy used medical devices.

Hungary: Used medical equipment can be sold, however it needs a CE mark. Further, there is little demand for used medical devices.

Indonesia: No Importation of used and refurbished medical equipment is allowed.

Israel: Importation is allowed, however, there are many regulations they must comply with and there is no demand.

Jordan: No importation of used and refurbished medical equipment is allowed.

Korea: Importation of used and refurbished medical equipment is allowed.  Procedures to obtain a pre-market license for a used medical equipment are the same in general as those for a new medical equipment.  However, used medical equipment (each imported unit) is subject to 100% inspection (test) at importers’ facilities with the companies’ quality control criteria, while new medical equipment is not required to test all the same products. The market for used medical equipment is limited in Korea though.    

Kuwait: No importation of used and refurbished medical equipment is allowed.

Malaysia: Importation of used medical equipment is allowed. Demand for this comes from the small healthcare practitioners. The public healthcare sector does not procure used medical equipment.  

Mexico: There is a strong market for refurbished medical equipment when it is accompanied by a warranty and technical support. 

Morocco: Importation of refurbished equipment is allowed. The Moroccan law does not forbid government entities –the main buyers– to buy refurbished medical equipment. However, for Used medical equipment a new law has been submitted banning the purchase of used medical devices and equipment. This law is expected to be implemented late 2015 or early 2016 since it has already been voted for. This is expected to improve the quality of medical equipment and offer a better quality of medical care to patients treated in Morocco. Refurbished equipment has a market with private entities.

New Zealand: Refurbished medical equipment is currently sold in NZ along with obtaining a Medsafe (WAND registry – for clearing medical devices) listing. There is a very small market though, with uptake only in the private sector. However, it is common for District Health Boards (Public Health System) to obtain refurbished equipment when they are on a Replacement loan equipment/repair contract with supplier.

Nigeria: Used medical equipment is allowed entry into Nigeria at zero duty charged.

Pakistan: Importation of used and refurbished equipment is allowed. Import of Radioactive materials and apparatus is subject to the prior approval of Pakistan Nuclear Regulatory Authority.

Palestinian Territories: Used and refurbished medical equipment is allowed to be imported; however, there is no demand due to specifications of international donor agencies that fund the Healthcare sector. 

Peru: No importation of used and refurbished medical equipment is allowed. Only physicians requiring equipment for their own use will be permitted to import one type of equipment per year.

The Philippines: Importation is allowed only in the private sector, which makes up approximately 65% of the market. Importation of radiation-emitting devices is not permitted. 

Poland: There are no restrictions in Poland on imports and/or the purchase of used medical equipment by either state-owned or private health care facilities. Used equipment purchases are made but no specific buying pattern has been identified. 

Please note that products must meet the European certification requirements and be CE marked.  Also, price is the main factor considered by all buyers of medical products in Poland. Important too is the local availability of services and spare parts. Quality is usually the next element considered. 

Romania: There are no restrictions on the sales and import of refurbished medical devices in Romania. The medical equipment must meet the European certification requirements and have the CE mark. Duties and taxes are applicable at the same rates to both new and refurbished equipment. The key end-user groups for this category are private hospitals, clinics and specialized ambulatory care segments.

Russia: Importation is allowed, but the products must hold a valid registration certificate of Ministry of Health, certificate of conformity and hygienic certificate. The market is limited to private clinics mostly. Only new equipment is allowed for sale through government tenders.

Serbia: Importation of used and refurbished medical equipment is permitted, but the products must meet local certification requirements in the form of local sales license, that is marketing approval issued by local State Regulatory Agency, based on European certification requirements and CE mark. There is a strong market potential for such equipment in private sector.

Singapore: Importation of used and refurbished medical equipment is permitted, but these must meet the regulatory requirements based on recommendations of the Global Harmonization Task Force (GHTF). The regulatory organizations that are considered independent reference agencies by the Singapore Health Sciences Authority are the U.S. Food & Drug Administration (USFDA), European Union (EU), Health Canada, Therapeutic Goods Administration (TGA), Health Canada and the Japan Ministry of Health, Labor & Welfare (MHLW). There is currently limited or no demand for used equipment. 

Slovak Republic: Importation of used and refurbished medical equipment is permitted, but the products must meet local certification issued by State Regulatory Agency (Slovak Institute for Drug Control), based on European certification requirements and CE mark.  

South Africa: Import is allowed, but local party will need importer’s certificate. Products must be FDA approved and/or CE mark. There is very limited market potential. Refurbished equipment will be subject to registration once the draft regulations become law.

Spain: Importation of used and refurbished medical equipment is permitted, but the products must meet the European certification requirements and be CE marked. There is not a strong market for such equipment.

Sweden: Importation of used and refurbished medical equipment is permitted, as long as the products meet the European certification requirements and be CE marked. However, there is currently no demand for used equipment.

Switzerland: Importation is allowed, but the market is close to non-existent. 

Taiwan: Imports of used equipment are treated as the same as new equipment. Prior to obtain import license, a premarket registration approval is required by the Department of Health. Due to the expectation that all medical equipment will be backed by an extended maintenance contract, there is virtually no market for refurbished items. The market for used/refurbished medical devices is very limited.

Thailand: No importation of used and refurbished medical equipment is allowed. 

Turkey: No importation of used and refurbished medical equipment is allowed. 

UAE: Importation is permitted, but government entities, the major buyers in this market, are prohibited to buy used and refurbished medical equipment.

Ukraine: Import of used and refurbished equipment is allowed, but the products must hold a valid registration. The public healthcare sector does not procure used medical equipment, the market is limited to private clinics mostly.

United Kingdom: Imports are permitted. There is not a lot of demand as agencies within the public healthcare sector, which is the largest purchaser of medical products, don’t buy used or refurbished medical equipment. 

Uruguay: Imports of refurbished medical equipment are authorized. All medical equipment, new, refurbished and/or recycled need to be registered by a local company and approved by the Ministry of Public Health prior to importation. Refurbished equipment needs to have a Technical/Refurbishing Protocol (full contact information of the company which refurbished the equipment must be provided).

Venezuela: Importation is allowed, but Government organizations, who are one of the major buyers, are not allowed to purchase them.

Vietnam: Import of used and refurbished medical equipment is strictly controlled by the Vietnam Ministry of Health (MOH). The Ministry of Science, Technology, and Environment must inspect and certify all imports of used medical equipment. In practical terms, MOH accepts used equipment for donation purposes only.

GE to stop making loans to biopharma companies, but will keep healthcare equipment financing arm

GE is divesting most of its GE Capital services arm to focus on its core strengths in industrial equipment, like airplane engines and MRIs and other imaging devices.

 

Read more here

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