A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

U.S. Medical Device Industry – Open for Business

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Uncertainty.  If there is one word that best describes the global outlook during the 2020 pandemic this might be one that everyone can agree on. 

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VietNam: High Growth Fast Market Access

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Vietnam has been quietly transforming their economy of 100 million people into a regional powerhouse. Through a combination of significant private investment, the US-China trade war, and their highly successful handling of the Coronavirus, Vietnam’s economy is expected to rebound quickly, especially with regards to manufacturing.

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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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Artificial Intelligence (AI) Software Registration in Singapore

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In December 2019, the Health Sciences Authority (HSA) of Singapore’s Ministry of Health released guidelines regarding software registration in Singapore, including a major section dedicated to AI software.

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Singapore Releases New Guidance of Medical Device Software

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Singapore’s HSA has updated their requirements for software application submissions, requiring the specific version number and iteration of the software to be sold in Singapore.

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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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HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIES

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By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.

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