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Hong Kong MDACS, Guidance Notes on Changes for Listed Medical Devices

Hong Kong Medical Device Division (MDD) issued formal guidance (GN-10 Guidance Notes on Changes for Listed Medical Devices) on the requirements to maintain compliance when making changes to a medical device registered with the Medical Device Administrative Control System (MDACS). The GN-10 guidelines include classification of whether changes to registered medical devices are major or minor and m..

Ministry of Food and Drug Safety, announces partial revision of regulations on the designation of medical devic-es subject to follow-up management

From November 17, 2023, it has been partially revised to clarify administrative procedures by preparing standards and procedures for lifting the designation of medical devices subject to follow-up management and to match the name of the medical device subject to follow-up management with the item name specified in the Regulations on Medical Device Items and Classes by Item. The major revisions a..

Guidance on partial revision of the Regulations on Cosmetics Safety Standards, etc.

Based on the results of the risk assessment, the Ministry of Food and Drug Safety announced some revisions, such as adding some ingredients of hair dye to the list of raw materials that cannot be used in cosmetics and adding a chemical substance identification number (CAS No.) such as raw materials that cannot be used in cosmetics to increase the convenience of identifying raw materials. Please ..

JNM Global/Cosmetic 2023.12.04