Tag Archive for: medical device regulations

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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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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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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Submission Changes in China: ToCs and the eRPS

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Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.

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ASIA ACTUAL INTERVIEW: THE FUTURE OF MEDTECH IN ASEAN

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Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.

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