Regulatory Affairs Update: Singapore

Singapore: Guidance for Good Submission Practice

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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