Reference to the Singapore Healthcare Services Act (HCSA), the Ministry of Health requires all staff of healthcare, regardless public or private healthcare, including personnel from outsourced partners or vendors who regularly work in the healthcare institution premise, to meet the measles and diphtheria immunity requirements by 3rd January 2022.
The Company needs a regulatory consultant who displays good knowledge in the criteria and documents requirement for HSA medical device registration.
The medical device is a disposable valve to facilitate switching between ventilators for intubated patient when they are transferred within and between hospitals. The device minimises the loss of airway pressure and prevent aerosolization of pathogens into the environment. The device is designed to connect to the current standard breathing circuit. The device does not contain any electronic component or software.
The consultant is to work closely with CGH appointed design house/manufacturer to draft the necessary documentation for medical device certification and assist the team to follow through full evaluation route of HSA Class B and above medical device certification
For more details on the scope, please email to the primary contact email address as per below.
The terms of this RFP/RFI/Tender have been posted at this site on the published date in their full intent and effect. CGH bears no responsibility for and shall not be bound by any changes made to such terms by unauthorised third parties. CGH does not guarantee that the terms received by you on this site comply with those as originally published. (If you wish to respond to this RFP/RFI/Tender, you are advised to verify such terms directly with CGH.) The Hospital does not bind itself to accept the lowest, the whole or any proposal.
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