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