Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
Tag Archive for: medical device regulations
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.
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.
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.
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.
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.
Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.