Historically, all of these countries have used European Union CE marking or United States Food and Drug Administration (FDA) medical device approval in lieu of their own medical device regulation, but each country is developing its own regulatory process, with adoption more advanced in Turkey and Saudi Arabia.
Until recently Pakistan had no established medical device regulatory system. Devices approved in their country of origin could be freely imported. A domestic regulatory scheme was proposed in 2011, but recent changes in administration have left the process in flux. Poor reimbursement in Pakistan means that most costs are out-of-pocket, leading to a strong demand for cheap or smuggled devices from illicit manufacturers.
"Low regulatory barriers to entry have made these national markets attractive to smaller competitors," said MRG Analyst Mirel Giugaru. "In Pakistan, particularly, all regulatory costs had already been paid in the country of origin, so it was relatively easy to realize additional revenues. But as regulations become more stringent, the marginal cost of complying can go up significantly, which favors larger companies, who are better able to absorb these expenses. It will also reduce competition from smuggled medical devices, and less-expensive devices from smaller, less-regulated manufacturers. As a result, there is a strong possibility that the dominant international companies, Medtronic, Boston Scientific and Abbott Vascular, will be increasing their share in all of these countries."
Millennium Research Groups Middle Eastern and South African Markets for Interventional Cardiology 2012 report includes procedure, unit, average selling price and revenue information, along with market drivers and limiters and competitive landscape for coronary stents, percutaneous transluminal coronary angioplasty (PTCA) balloon catheters, and IC accessory devices in Pakistan, Saudi Arabia, South Africa and Turkey.
About Millennium Research Group
Millennium Research Group (www.MRG.net), a Decision Resources Group company (www.DecisionResourcesGroup.com), is the global authority on medical technology market intelligence and the leading provider of strategic information to the healthcare sector. The company provides specialized industry expertise through multiclient market research, ongoing Marketrack™ projects, customer loyalty tracking, facility-level procedure forecasting, and customized solutions.
About Decision Resources Group
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