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guideline 3

MFDS, Publication of guidelines for evaluating physical and chemical properties of non-absorbable polymer materials for biological safety evaluation of medical devices

The Ministry of Food and Drug Safety published 「Guidelines for evaluating physical and chemical properties of non-absorbable polymer materials for biological safety evaluation of medical devices」 on April 08, 2024 to help prepare biological evaluation data for medical devices by explaining the requirements, evaluation principles, and processes of data on physical and chemical characteristics ana..

MFDS, Published Guidelines for Application of Medical Device GMP Usability_U-Healthcare electrocardiograph

U-Healthcare Medical Device? Based on wired and wireless communication infrastructure, It is a medical device that enables medical personnel to remotely monitor patients' biological signals measured in real time in non-medical places, manage their health, and provide appropriate health care services in a timely manner. Recently, the Ministry of Food and Drug Safety published guidelines for quali..

Vanuatu TRBR, Festlegung der Leitlinien für die nationale Typgenehmigung und SRD

Vanuatu TRBR (Telecommunications, Radiocommunications & Broadcasting Regulator) hat die "Guidelines for General User Wireless Licence (GURL) for National Type Type-Frameworks and SRDs" veröffentlicht. Alle SRDs, die nach Vanuatu importiert oder in Vanuatu hergestellt und verwendet werden, müssen die entsprechende Leitlinie einhalten, die die meisten CE-Standards angewendet werden. Für weitere Fr..