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Introduction to Clinical Evaluation Reports (CER) for Europe
Whether you're a small device manufacturer struggling to market your first product, or a multinational working on the 8th generation of your device,
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In-Depth: Europe CE Marking Medical Device Approval and Compliance
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Introduction to the Israel AMAR Medical Device Registration Process
Israel is a small country with significant medical device needs. Medical devices in Israel are regulated by AMAR and the registration process relies
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In Depth: Japan Medical Device Approval and Compliance
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Introduction to Japan's Medical Device Approval Process
Japan is the largest market for medical devices in Asia. Though Japan has less than one-tenth (1/10) the population of China, the Japanese spend more
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Introduction to Malaysia's medical device approval process
Malaysia. Over 30 million people and one of most robust and dynamic markets for foreign medical device manufacturers seeking emerging market
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In Depth: Mexico Medical Device Approval and Compliance
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Introduction to Russia's Medical Device Approval Process
Russia is a promising market for medical devices, but the regulatory process can be challenging. The Russian regulatory authority, Rozsdravnadzor,
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