A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
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.
Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
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.
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.
Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.
India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India.
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