Singapore Health Sciences Authority (HSA) consulting
Getting medical devices approved for import and use can be complicated and confusing. The documentation and process can be extensive and time consuming. Yet sometimes a device classified as a medical device in another country is not so classified in Singapore
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We can help navigate to the best outcome.
HSA related services
Let us review your new device or product to:
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Understand product market and purpose
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Determine licenses and approvals needed (if any)
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Coordinate with you and with manufacturer to prepare required documents for submission to HSA
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Carry out submission through HSA MEDICS portal
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Coordinate with you, manufacturer and HSA to address any questions and issues until approval
Following options are available (scroll down to Contact Us for more details):
Initial Evaluation
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Review basic documents such as brochure and user manual
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Conduct self assessment on HSA portal to determine medical device classification (if any)
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Advise on documents to align with intended usage
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Fee: Fixed S$200
License application
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Assist with preparation of documents depending on the license type (GN-17, GN-26, GN-27)
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Work with client and manufacturer to prepare above
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Submit via portal
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Respond to HSA queries with input from manufacturer and client
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Update portal with responses as required
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Fee: S$120 per hour - typically 4 hours for GN26/27 and 40 hours for GN-17 depending on complexity and completeness of documentation
About Us
Ian Selbie is the Director and Senior Consultant at Caerlee. Also see: https://www.linkedin.com/in/ianselbie/ for details including references.
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Email Ian on ian@caerleeservices.com or use WhatsApp or call for a chat on +65 98223314
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Certified Information Security Professional (CISSP) by (ISC)2 and a Certified Fraud Examiner (CFE) by the Association of Certified Fraud Examiners.
