The Quality and Regulatory Workshop (QRW) aims to uplift the medical device industry standards by providing a working platform and sharing experience amongst our participants in matters relation to regulations, quality and compliance.

Following the success of previous QRWs, this third workshop aims to share audit experience by our industry representatives in dealing with on site compulsory audit requested by foreign authorities such as US FDA, Korean FDA, China FDA, Japan PAL, and Singapore HSA. Representative from the Medical Device Control Office will also share with us the Hong Kong audit requirements. Business areas to be covered will include distribution, contract/brand manufacturing, China manufacturing permit, and import and export licence requirements.

GS1 Hong Kong representative has been invited to talk about the requirements of Unique Device Identification nomenclature system and its application in general.