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Registration Process

Mexico is one of the largest medical device importers in the world, making it an attractive market for foreign companies. The Federal Commission for Protection of Sanitary Risks (COFEPRIS) is responsible for the review, approval, and post-market monitoring of any healthcare product in Mexico. However, regulatory requirements are complex, and it can be difficult to identify the most efficient submission route for your products. In this free webinar, we will examine current medical device registration requirements in Mexico and recent regulatory changes. WHAT YOU WILL LEARN: • Regulatory...
Download the Chart on the Regulatory Approval Process in South Korea
Medical device and IVD manufacturers that want to sell their products in South Korea will have to follow the requirements of the Medical Devices Act, a set of regulations put forth by the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration). For more information on getting approval for the South Korean Market, download the chart.
Download the Chart on the Medical Device Approval Process in Europe
In order to commercialize medical devices in the European Union , a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements of the Medical Devices Directive (MDD), or Active Implantable Medical Device Directive (AIMD) as they apply to your product. For a more detailed look at the European regulatory process for medical devices, download the chart below. Interested in CE Marking under the new EU Medical Device Regulation (MDR 2017/745)? Download our MDR process chart.
Download our whitepaper Introduction to CE Marking for Medical Devices in Europe
Are you a medical device manufacturer with your eye on the European market? If so, you've probably heard the term "CE Mark". The CE Mark is the key to selling your device in Europe, as all medical devices are required to bear this symbol. However, you can't simply stamp "CE" on your device. The CE mark certifies that your device meets the requirements of the appropriate EU Directive. Showing your device conforms to these requirements is a complex process with lots of players. In this white paper, we'll answer your biggest questions about European CE Marking, including: What is CE Marking and...
How long does it take the FDA to clear 510(k) submissions? We look at 5 years of data to identify trends.
Every year Emergo examines published data on medical devices cleared by the US Food and Drug Administration (FDA). The 15,000+ device clearances we analyzed in March 2017 went through the FDA’s Premarket Notification program, known as the 510(k) process. Technically, the FDA does not “approve” devices; they clear them for sale in the US. The 510(k) process applies to nearly all Class 2 devices, and less than 10% of Class 1 devices. We sorted all devices based on the date they were cleared by FDA, not the date they were submitted. Want to see average review time for YOUR specific device? Be...
Watch this Short Video: Introduction to Japan's medical device approval process
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