HONG KONG: GUIDANCE UPDATED ON CHANGE APPLICATION FOR LISTED MEDICAL DEVICES (GN-10) – July/August 2026

• 2026-08-25 04:12:25

Hong Kong's Medical Device Division (MDD) has revised the Guidance Notes for Changes of Listed Medical Devices (GN-10), effective 26 June 2026. The update introduces new non-reportable change categories, revised major change criteria, conditional approval outcomes, and additional compliance requirements. Manufacturers and LRPs should review the revised requirements to ensure compliance under MDACS.

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HONG KONG: Guidance Issued on Change Application for Listed Medical Devices (GN-10) –January/February 2024

• 2024-01-26 06:44:31

“Guidance Notes (GN-10) on Changes for Listed Medical Devices” has been issued by Hong Kong MDD on 30th November 2023 which aim to assist the Local Responsible Persons (LRP) in categorizing, managing and reporting changes of listed medical devices. This guidance has been effective since 1st January 2024.

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TAIWAN: Guidelines for Post-market Change Application of Software as Medical Device – March, 2022

• 2022-03-25 11:51:14

Software as Medical Device (SaMD) is rapidly developing and frequently updating its compatible hardware. In order to ensure the safety, performance, and quality of SaMD while keeping in line with international standards, TFDA has released a guideline regarding post-market change application of SaMD.

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