Tag Archive for: medical device regulations

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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THAILAND SUSPENDS PLAN TO REGULATE HAND SANITIZER AS MEDICAL DEVICE

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In the wake of the COVID-19 outbreak, the Thai FDA announced on March 5, 2020 that they will cancel their plans to begin regulating alcohol gel sanitizers as medical devices.

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MALAYSIA IMPLEMENTS ADVERSE EVENTS REPORTING REQUIREMENTS FOR MEDICAL DEVICES

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On July 1st, 2020 the Malaysia Medical Device Authority (MDA) will implement the Medical Device (Duties and Obligations of Establishment) Regulations 2019, implementing guidelines for Adverse Event (AE) Reporting within the current mandatory registration system.

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THAI FDA ALLOWS SALES OF AT-HOME HIV TEST KITS

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The Thai government has voiced their commitment to ending the epidemic by supporting preventative awareness, access to cost-effective tests and treatment resources through public investment and/or private partnerships.

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Voluntary Medical Device Registration in Hong Kong

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Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.

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GUIDANCE ISSUED FOR IMPORTING UNREGISTERED MEDICAL DEVICES INTO KOREA

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Korea’s Ministry of Food and Drug Safety (MFDS) recently published final revisions regarding importing non-registered medical devices under special circumstances, including for research and personal use only, scarce or urgently needed, to be used by a Korean laboratory, clinical trials and/or orphan products.

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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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DON’T PLAY ROULETTE WITH YOUR RUSSIAN TEST REPORTS

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Considering the complexity of the importing test samples and the risk of test laboratories losing accreditation, it is important for manufacturers seeking medical or diagnostic device registration in Russia work with an experienced, local partner who can make an informed selection of test laboratories and take fast corrective action should the selected lab be affected.

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