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Hi forum, Would anybody know if there is a separate approval process in these provinces without getting a formal approval from NMPA for China ? Thanks & Regards, Rashmi Pillay Regulatory Affairs Manager Ellex Lumibird Medical group 3-4 Second Avenue, Mawson lakes SA 5095 Tel. +61 8 7074 ...

Hi, Is anybody aware of the latest QR code requirement of Japan(effective from 1st August'23) required in addition to the UDI label ? Thanks & Regards, Rashmi Pillay Regulatory Affairs Manager Ellex Lumibird Medical group 3-4 Second Avenue, Mawson lakes SA 5095 Tel. +61 8 7074 8105 ...

Hi, We are in the process of 510k submission (traditional). Review and Clearance timelines would be a challenge , as are targeting a launch in 3 months. Does any one have any recent experience with third party review and a third party reviewer that you can recommend? ( Device -ophthalmic laser , ...

Hi Erik, Thanks for your feedback I am referring to the below exception , underlined "EU MDR Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons 1.A distributor, importer or other natural or legal person shall assume the obligations incumbent ...

Hi In cases where the virtual manufacturer (i.e has their own trademark) becomes the distributor and the legal manufacturer is separately mentioned on the label; how does the MDR obligations under the articles 25 and 31 be fulfilled, as the virtual manufacturer has the agreement with their importers ...