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

How New EU MDR Requirements Will Affect Registrations in Asia

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As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.

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Hong Kong Refines Medical Device Post-Market Surveillance Report Form

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On December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.

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Medical Device Advertising Requirements in Asia

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In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.

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Hong Kong to Pilot Prioritizing Some Listed Medical Devices

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

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Asia Actual is the Best Medical Device Consulting Company in Asia

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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.”

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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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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 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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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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