Hong Kong Medical Device Regulatory Updates

Hong Kong Refines Medical Device Post-Market Surveillance Report Form

January 27, 2023/in Hong Kong, Latest Updates/by Albert Pranoto

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

Medical Device Advertising Requirements in Asia

July 22, 2022/in Australia, China, Commercial Services, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Russia, Singapore, South Korea, Taiwan, Thailand, United States, Vietnam/by Bryan Gilburg

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.

How New EU MDR Requirements Will Affect Registrations in Asia

August 12, 2022/in China, Hong Kong, India, Indonesia, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam/by Bryan Gilburg

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.

Hong Kong to Pilot Prioritizing Some Listed Medical Devices

August 30, 2022/in Commercial Services, Hong Kong, Latest Updates/by Eric Leung

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

Hong Kong’s MDD Formalizes Expedited Approval Scheme

January 21, 2022/in China, Commercial Services, Hong Kong, Latest Updates/by Eric Leung

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

December 16, 2020/in China, Commercial Services, Hong Kong, Latest Updates/by Eric Leung

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

June 10, 2020/in Hong Kong, Latest Updates/by Bryan Gilburg

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.