A list of recently updated articles regarding Hong Kong medical device regulatory updates from the MDD and other locak governing bodies.

Hong Kong to Pilot Prioritizing Some Listed Medical Devices

Hong Kong’s MDD announced the start of a pilot program that will give preference to MDACS listed medical devices.

Asia Actual is the Best Medical Device Consulting Company in Asia

Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”

Hong Kong’s MDD Formalizes Expedited Approval Scheme

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

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

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

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

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 Shipments During the COVID-19 Pandemic

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

Voluntary Medical Device Registration in Hong Kong

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

4 Product Development Decisions that Impact Sales Performance in Asia

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.