US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
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.
Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
A large number of medical device listings in Hong Kong are coming to the end of their 5-year validity period and must undergo a re-registration process in order to maintain an active Medical Device Listing.
Legislation for the creation of mandatory medical device regulations was introduced into the current legislative session in Hong Kong. Regulations and requirements are expected to be very similar to those under the current voluntary system. If passed into law before the close of session in July, implementation is expected in the beginning of 2018.
Because the voluntary Medical Device Administrative Control System (MDACS) has been in place since 2004, the Department of Health is not expected to provide for a transition period. Devices that are not registered by the implementation date will loose access to the Hong Kong market. Manufacturers are encouraged to participate in the voluntary system to avoid any potential loss of market access.
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