The novel characteristics of AI software and Software as Medical Devices (SaMDs) are stressing bureaucratic regulatory, customs and taxation systems around the world. Thailand is no exception.
Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all 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.
Chinese officials are taking steps to reduce fraudulent exports. Only products with NMPA registration can be exported to ensure standards and quality during COVID-19 crisis.
The PCSO is a major source of funding for new hospital construction and medical device and equipment purchases and is often overlooked by outside suppliers. Medical device manufacturers should discuss with their Philippines distributors about what opportunities are available through the PCSO.
Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
Medical device manufacturers are advised to prepare e-Catalogue applications early and be vigilant for the enrollment announcement. Implementing an optimal pricing strategy will be critical to successful public hospital sales. The e-Catalogue system also increases the importance of independent license holding in Indonesia because there is little room for regional dealer margin under the price scheme.
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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