AI-powered · Expert-verified · Singapore medical devices
Singapore HSA medical device registration dossier support
Technical-file and dossier preparation support for medical device distributors, including IVD companies, preparing for Singapore HSA registration.
Singapore professional fees from SGD 799.
Designed for
Medical device registration dossier support
For medical device distributors, diagnostic companies, importers, and regional product owners. Everest Nova prepares documentation for client submission; regulator approval remains independent.
Where projects stall
The market-access problem is usually a documentation problem first.
Device classification, claims, IFUs, labels, certificates, and technical evidence need a coherent structure.
Distributor teams may have commercial rights but incomplete manufacturer support.
Submission delays often start with preventable technical-file gaps.
What Everest Nova prepares
- Device evidence checklist
- Technical-file organization
- Labeling and IFU document review notes
- Final deliverable package through secure portal
Scope and market
Everest Nova is based in Singapore. Its dossier work draws on the medical technology experience described below. Everest Links Pte Ltd is an ISO13485 and GDPMDS certified Singapore medtech company with 15 years of experience and work across hundreds of regulator-facing product registrations. Its operating history spans medical devices, diagnostics, oncology, infectious disease, allergen diagnostics, point-of-care solutions, rapid antigen tests, pulse oximeters, ultra-rapid PCR, dengue testing, and allergy testing.
Optional Singapore Registrant Support is SGD 300 per application.
Next step
Start with a structured intake, not a messy email thread.
AI-assisted screening helps focus the first document requests; medtech experts verify the context, prepare the work, and control final delivery through the Everest Nova portal.
Everest Nova professional service fees are separate from government, regulatory authority, CAB, conformity-assessment, licensing, registration, and other third-party fees. Customers are responsible for paying those fees directly where applicable. Everest Nova prepares submission-ready regulatory dossiers. Direct submission to regulatory authorities is not included.
Everest Nova prepares documentation packages for client submission and does not guarantee regulatory approval. Approval outcomes depend on the product, evidence quality, data completeness, manufacturing controls, and the independent assessment of the relevant authority.
Also see Singapore regulator guide and Malaysia regulator guide.