MEDICINES REGISTRATION HARMONISATION IN AFRICA. 1st ed. N.p., 2016. The Ministry of Health, Belize N.p., 2016. 1st ed. Medicare does not cover travel outside of the United States with very few exceptions, primarily certain emergency situations. 27 Dec. 2016. There may be certain drug regulations that may apply to your medical device. Web. N.p., 2016. International Accreditation Forum, 2011. 1st ed. N.p., 2016. Medicalcouncilmu.org. The list of countries compiled is based on our research and is not intended as explicit guidance for a particular situation or a product. Horseed Media • Somali News • Politics & Opinion. N.p., 2014. The German Society for Regulatory Affairs. Yes, there are a number of countries where you can import your medical products with simply an import permit and/or notification to the local Ministry of Health while avoiding formal regulatory approval. However, as Overseas Countries and Territories of the EU, the EU law applies here, only as necessary to comply with the association agreement they have with the EU. There are however, some small exceptions that allow you to use your Medicare benefits internationally. In many of the countries in Africa and some of the smaller Asian markets, there are no regulatory authorities for medical devices. Sources about countires without medical regulatory: “Country Data – Global Atlas Of Medical Devices 2014 Update”. Web. London, UK: World Health Organization, 2014. A new Commonwealth Fund survey finds Medicare beneficiaries get worse care and face higher health costs than people 65+ in many other countries. 27 Dec. 2016. However, since Medicare doesn't cover you overseas, you might be tempted to think you'll be able to stop paying Medicare Part B premiums that … N.p., 2016. A, Abdirahman. “Guidelines For Application For Registration Of Medicinal Products 2006(DRA)”. Mahe, Seychelles: REPUBLIC OF SEYCHELLES, Ministry of Health and Social Development, 2009. the 50 states of the U.S., the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands. Web. This fact sheet explains some of the exceptions that would allow you to get coverage outside the U.S. under Original Medicare Part A (Hospital Insurance) and/or Medicare Part B (Medical Insurance). Some Medicare Advantage Plans and Medicare Supplements offer some foreign travel coverage. “Regulatory Requirements Of Medical Devices In MENA Countries”. We use cookies to understand how you use our site and to improve your experience. With the constant change in regulations, ensure to seek professional guidance before entering any of these markets. “DOING BUSINESS WITH THE CAYMAN ISLANDS”. Medical Devices Regulatory Compliance In Latin America. If you or your team has had a differing experience in any of these markets, we welcome your comments and any new information to further share with the medical device community. “Medical Council Of Mauritius”. “Health Sector Reform Program”. Web. Web. It is not a matter of what countries accept Medicare. Web. 1st ed. 27 Dec. 2016. 27 Dec. 2016. Moreover, regulations not only differ by country but are also product-specific. Gambia. Samadi, Dr. Fatemeh. 27 Dec. 2016. 27 Dec. 2016. 1st ed. Azerbaijan, Timor-Leste, and Tonga have regulations for pharmaceutical drugs. 27 Dec. 2016. https://www.who.int/medical_devices/countries/en/. 27 Dec. 2016. info@url.cz, All:. For Botswana, Burkina Faso, Chad, Comoros, Grenada, Marshall Islands and the Central African Republic, there is insufficient data to determine if any medical device regulations exist. www.who.int. “Gambia:Analytical Summary – Medical Products, Vaccines, Infrastructures And Equipment – AHO”. Caribbean Export Development Agency www.carib-export.com/. 1st ed. Due to the lack of infrastructure, mostly all imported medical devices are either purchased by the government or acquired through donations, e.g. Please fill out the form below and one of our team members will get back to you as soon as possible! (Please note the ‘may.’) Web. Regulatory Affairs Professionals Society, 2016. By continuing to use our site, you accept our use of cookies. Web. Web. Web. 27 Dec. 2016. Rugera, Simon Peter et al. Our research revealed that many of the smaller government bodies have appointed Intertek as their sole provider of pre-shipment inspections. Pretoria, South Africa: N.p., 2011. 27 Dec. 2016. http://www.aho.afro.who.int/profiles_information/index.php/Niger:Medical_products,_equipment_and_infrastructure SEYCHELLES NATIONAL MEDICINE POLICY. Web. 27 Dec. 2016. When the foreign hospital is closer and easier to get to than one in your home country, Medicare may pay for those services. The regulatory landscape is dynamic; rules of the road are always changing. Cera, Carolina. (The official definition of the U.S. includes the 50 states and the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands, American Samoa, and the Northern Mariana Islands—you can use your Medicare benefits in these countries.) Web. N.p., 2014. https://www.who.int/medical_devices/countries/en/ Web. The big question our team at RegDesk gets asked all the time by small medical device companies is, “Are there any countries that do not require any regulations?” We heard your request. 27 Dec. 2016. Ramaley, Grant and Azusa Nakagawa. 27 Dec. 2016. World Health Organization. 27 Dec. 2016. N.p., 2016. The big question our team at RegDesk gets asked all the time by small medical device companies is, “Are there any countries that do not require any regulations?” We heard your request. Denver, CO: Rocky Mountain Regulatory Affairs Society, 2016. “Somalia: Federal Cabinet Passes Medicinal Drugs Regulatory Policy”. N.p., 2007. Tuv-sud.com. Yes, there are a number of countries where you can import your medical products with simply an import permit and/or notification to the local Ministry of Health while avoiding formal regulatory approval. “Brunei”. If you have any questions or need any assistance in gaining insights specific to your products for any of these markets, contact me directly at drita@regdesk.co. 27 Dec. 2016. Misguided decisions can lead to substantial delays to market and in many cases prevent companies from ever entering a market. Global regulatory statutes significantly impact healthcare companies. In some cases, Medicare can pay for inpatient hospital services in these countries if: You live in or are inside the U.S. and need medical care, but the closest hospital is in Canada or Mexico. Web. If you were collecting Social Security benefits when you became Medicare-eligible, you may have been automatically enrolled in Part A. Some of these markets are in the process of implementing regulations so ensure to consult a local expert and/or the local Ministry of Health. Web. Many times it is in the best interest of these small medical device companies to identify markets with the least (regulatory) burdensome approach. Aho.afro.who.int. Obtaining regulatory approval is one of the biggest hurdles faced by these companies. Medical Device Regulation In Latin America. “LAW OF THE REPUBLIC OF AZERBAIJAN “On Medicinal Products”.

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