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Medical Device Administrative Control System (MDACS) 4 1 1 6 Instructions for use shall be provided with the device However, they may not be needed or may be abbreviated for devices of Class I and Class II if the devices can be used safely and as intended by the manufacturer without any such instructions
FINAL DOCUMENT - ahwp. info Information on the current regulatory requirements and practices for the use of e-Labels and e-IFUs was collated using the framework of a standard questionnaire (Appendix A) This questionnaire was sent to regulatory agency representatives and or industry members for completion and returned
Electronic IFU Regulation in Asia The table below outlines where e-IFU is allowed, the types of use environments it applies to, who maintains the e-IFU content, and whether a notification is required to switch formats
Medical Devices Regulations in Hong Kong - Artixio Medical devices in Hong Kong must have clear and accurate labelling, providing vital information for users and regulators The labelling should include the device’s name, intended use, manufacturer’s details, instructions, warnings, precautions, and relevant symbols
Hong Kong Medical Device Regulations - qservegroup. com The MDD is responsible for implementing the Medical Device Administrative Control System (MDACS) and developing a long-term statutory regulatory framework for medical devices in Hong Kong (HK)
Regulation of Medical Devices in Hong Kong There is no statistics about the medical device industry in Hong Kong Most of the medical devices used are imported It is estimated that there are around 100 small and medium Hong Kong manufacturers Most of the manufacturing sites are in Mainland China Most of products manufactured are OEM products
Title: Principles of Regulatory Requirements for Electronic . . . Labelling includes the label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents (ISO 13485:2016)
Understanding eIFU for Medical Devices: A Comprehensive Guide For healthcare professionals and users to benefit from electronic instructions for use (eIFU), it’s not enough for the file to be digitally accessible The manufacturer must clearly communicate that an eIFU is available and ensure it can be accessed quickly and reliably