The Health Sciences Authority (HSA) Singapore conducted a workshop to elaborate on the correct procedures, processes, roles and responsibilities of a registrant and a dealer during submission of documents with the Medics and Oscar systems. The highlighted information is as below:
- Listing of existing tools and guidelines for specific group of Medical Device/IVD.
- Various guidelines on drafting of mandatory documentations.
- Requirements of English language for all documentations and digital signatures.
- Correct ways of filling up standard templates e.g. TR-01 Reference Agencies.
- Various ‘Scenario’ based questions are discussed e.g. “If I have a new device but the sterilization validation and shelf-life validation (e.g. packaging and functionality testing) are conducted on the predicate?”
- Discussion on Change Notification, UDI, FSCA reporting requirements and others.
Further information for the Good Submission Practice can be accessed here.
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