Healthcare Technologies Resource Guide - Export.gov

More documents

Recommendations

Info

14 • Demand for invasive and noninvasive surgery equipment, oncology, ultrasound equipment, invitro diagnostic equipment, urology equipment, laboratory and testing equipment, diagnostic imaging equipment, equipment for haemodialysis, tissue and blood bank related equipment, veterinary turnkey project equipment, hospital care equipment, information systems, modern patient monitoring systems, hospital management systems, new high tech products such as laser instruments, MRI and computerized systems for cosmetic, dental, aesthetic and restorative medicine. • X-ray systems, dental mechanical tools and instruments, dental surgery services, surgical tools, chairs, ultrasound equipment, photopolymer equipment, physiotherapy equipment, abrasive tools, maxillary surgery, anesthetics, sterilizing equipment, fittings, appliances, metal workplaces, ceramic work places and plastic workplaces • Telemedicine and the introduction of an electronic healthcare portal to be based on unified healthcare database files for every Bulgarian citizen fully compatible with EU standards. Market Entry There are no specific challenges to the business environment which could be considered a serious threat. The institutions responsible for regulatory monitoring of market entry rules and laws are the Ministry of Healthcare (www.mh.government.bg), Bulgarian Drug Agency (bda.bg), National Health Insurance Fund (nhif.bg), National Veterinary Institute (vetinst.bg) Current Market Trends Among the healthcare short term priorities outlined by current and former Ministers are the improvement of prophylaxis and prevention in the fields of maternal healthcare, improvement of emergency care, improvement of junior dental healthcare, early diagnostics of breast and prostate cancer; introduction of new non-invasive surgeries, reduction of prices for drugs; introduction of hightech biotechnology and products. Another aspect of healthcare reform is related to the measures which have to be introduced by the Bulgarian Ministry of Agriculture and its newly established Food Safety Agency concerning sanitation and eradication of pandemic diseases. Being the entry point to the EU veterinary markets, Bulgaria is mandated to carefully and strictly undertake sanitation and eradication measures of any possible veterinary pandemic diseases such as Classic Swine Fever, Foot-and-Mouth disease, Bird Flu. Main Competitors Main competitors are all major EU companies which have maintained a presence in the local market for decades. Some Asian firms are also present in the local healthcare market. Current Demand Best sales prospects are generally outlined in the previous sections of the present report. Registration Process Mandatory required certifications are the CE mark as well as some ISO standards such as ISO 9001, ISO 13485, ISO 13795. Medical equipment and consumables, which are subject to the mandatory registration regime can be viewed on the web page of the Bulgarian Drug Agency (bda.bg). Few exceptions are made in cases where Bulgaria has Mutual Recognition Agreements with individual US companies, which have production facilities outside of the USA. Barriers There are no significant barriers on healthcare products in Bulgaria. U.S. Commercial Service Healthcare Technologies Resource Guide | 2012–2013
Some tariff and non-tariff barriers are reported in the pharmaceutical market sub-segment which are reported by the LAWG in Bulgaria and are included in the National Trade Estimate report. Trade Events Medicus, Dento, Galenia October 30–November 2, 2013 • Plovdiv, Bulgaria Pharmaceuticals, laboratory equipment, and dental technology. BaSS (Balkan Dental Society) Meets annually • Varna, Bulgaria American Healthcare & Natural Products Expo 2013 February 29–March 1, 2013 US healthcare technologies, products, and equipment Available Market Research • Bulgaria Dental Equipment Market Overview • Bulgaria Pharmaceutical Market Overview U.S. Commercial Service Healthcare Technologies Resource Guide | 2012–2013 15
Page 1: Healthcare Technologies Resource Gu
Page 4 and 5: iv What Can the U.S. Commercial Ser
Page 6 and 7: 2 Argentina Summary Overall healthc
Page 8 and 9: 4 Australia Summary The medical equ
Page 10 and 11: 6 Austria Summary Austria is a dyna
Page 12 and 13: 8 The Austrian market for medical e
Page 14 and 15: 10 potential. Orthopedic products,
Page 16 and 17: 12 to replace bigger and more expen
Page 20 and 21: 16 Chile Summary As the United Stat
Page 22 and 23: 18 Barriers Chile has a favorable i
Page 24 and 25: 20 driving factors include demand f
Page 26 and 27: 22 Czech Republic Summary The healt
Page 28 and 29: 24 EXPODENT October • Prague •
Page 30 and 31: 26 the best solution, possibly by b
Page 32 and 33: 28 public sector bases most purchas
Page 34 and 35: 30 Current Market Trends Egypt’s
Page 36 and 37: 32 human body solely or principally
Page 38 and 39: 34 Other than the risk assessment s
Page 40 and 41: 36 Coming Soon: New Regulatory Fram
Page 42 and 43: 38 Finland Summary High quality and
Page 44 and 45: 40 France Summary Total market dema
Page 46 and 47: 42 Barriers There are no significan
Page 48 and 49: 44 surgery where, according to an e
Page 50 and 51: 46 Tariffs, Import Regulation There
Page 52 and 53: 48 Trade Events MEDICA with Compame
Page 54 and 55: 50 the private sector’s expenditu
Page 56 and 57: 52 Main Competitors In the Greek ma
Page 58 and 59: 54 Guatemala Summary Present situat
Page 60 and 61: 56 Medical equipment is constantly
Page 62 and 63: 58 distributors handle several bran
Page 64 and 65: 60 India Summary The Indian healthc
Page 66 and 67: 62 The opportunity also exists for
Page 68 and 69:
64 Current Demand Best Prospects
Page 70 and 71:
66 Irish labeling requirements are
Page 72 and 73:
68 Israel Summary U.S. medical devi
Page 74 and 75:
70 Italy Summary Italy is a mature
Page 76 and 77:
72 Strategic areas, in which there
Page 78 and 79:
74 1. The U.S. firm can ask their i
Page 80 and 81:
76 Jordan Summary • Medical Touri
Page 82 and 83:
78 seeking treatment in the Kingdom
Page 84 and 85:
80 Kenya Summary Kenya is the most
Page 86 and 87:
82 Republic of Korea Summary The Ko
Page 88 and 89:
84 Tariffs Tariffs of medical devic
Page 90 and 91:
86 In summary, selecting the approp
Page 92 and 93:
88 Main Competitors Most large inte
Page 94 and 95:
90 The Inspectorate and the RIVM en
Page 96 and 97:
92 New Zealand Summary All New Zeal
Page 98 and 99:
94 Nigeria Summary Nigeria is a net
Page 100 and 101:
96 Norway Summary Norway is one of
Page 102 and 103:
98 The Philippines Summary The medi
Page 104 and 105:
100 The Center for Device Regulatio
Page 106 and 107:
102 locate an appropriate agent/dis
Page 108 and 109:
104 Trade Events SALMED March 2014
Page 110 and 111:
106 component of the Portuguese med
Page 112 and 113:
108 Current Demand For 2011, the Mi
Page 114 and 115:
110 the National Health Project in
Page 116 and 117:
112 Saudi Arabia Summary The Saudi
Page 118 and 119:
114 3. King Faisal Medical City in
Page 120 and 121:
116 Trade Events MEDEXPO Saudi Arab
Page 122 and 123:
118 The Serbian market is very rece
Page 124 and 125:
120 Resources Ministry of health of
Page 126 and 127:
122 Doctors here are also pushing e
Page 128 and 129:
124 Main Competitors Slovakia’s m
Page 130 and 131:
126 Spain Summary According to the
Page 132 and 133:
128 Main Competitors The United Sta
Page 134 and 135:
130 Current Market Trends Two main
Page 136 and 137:
132 Taiwan Summary Taiwan, an islan
Page 138 and 139:
134 Trade Events Taiwan Internation
Page 140 and 141:
136 Medical tourism is a new sector
Page 142 and 143:
138 Ukraine Summary In 2011, the Uk
Page 144 and 145:
140 The Ukrainian market is recepti
Page 146 and 147:
142 Current Market Trends • The U
Page 148 and 149:
144 U.S. Commercial Service Healthc
Page 150 and 151:
146 U.S. Commercial Service Healthc
Page 152 and 153:
148 Certification Reference Chart E
Page 154 and 155:
150 Subsector Reference Chart Ratin
Page 156 and 157:
152 Contacts The U.S. Commercial Se
Page 158 and 159:
154 Vermont Susan Murray—Montpeli
Page 160:
1208-05-17
show all

Healthcare Technologies Resource Guide - Export.gov

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?