Hong Kong’s MDD Formalizes Expedited Approval Scheme

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Hong Kong’s Expedited Approval Scheme has been upgraded from a trial. Approvals from at least 2 GHTF countries plus China.

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NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland China

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

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Voluntary Medical Device Registration in Hong Kong

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

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4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

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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.

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MEDICAL DEVICES SHIPMENTS DURING THE COVID-19 PANDEMIC

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COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.

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HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIES

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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.

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Medical Device Re-Registration in Hong Kong

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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.

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