Tag Archive for: medical device sales

Asia Actual is the Best Medical Device Consulting Company in Asia

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Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”

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LAUNCHING AI DEVICES AND SOFTWARE AS MEDICAL DEVICES IN THAILAND

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The novel characteristics of AI software and Software as Medical Devices (SaMDs) are stressing bureaucratic regulatory, customs and taxation systems around the world. Thailand is no exception.

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CHINA: REGULATORY AND COMMERCIAL UPDATES

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The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China

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THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKET

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Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.

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CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LIST

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As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.

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CHINA TAKES STEPS TO ENSURE QUALITY OF COVID-19 RELATED EXPORTS

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Chinese officials are taking steps to reduce fraudulent exports. Only products with NMPA registration can be exported to ensure standards and quality during COVID-19 crisis.

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CLIENT SUCCESS: ICECURE MEDICAL GROWS SALES IN ASIAN MARKETS

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Asia Actual assists IceCure in achieving goals for continued expansion in Asia

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CHINA CHANGES CLINICAL DATA REQUIREMENTS FOR MEDICAL DEVICE REGISTRATION

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The changes to clinical data requirements will significantly decrease the regulatory burden for many medical device manufacturers seeking to access the Chinese market by eliminating the time and expense of conducting a local clinical trial.

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TROUBLESHOOTING U.S. HOSPITAL SALES RESULTS

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Medical device manufacturers looking to establish or improve sales in the US market should contact our team for market insight and strategy development.

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CHINA WARNS MANUFACTURERS ABOUT RISK ASSESSMENT REPORT DEADLINE

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Asia Actual works with highly experienced professionals in China that can provide you with accurate and timely Risk Assessment reports for your products that will not only satisfy the NMPA’s requirements but could also be used for updating Clinical Evaluation Reports in other markets.

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