AI-powered · Expert-verified · Medical device distributors
Regulatory dossier support for medical device distributors
A secure dossier preparation workflow for distributors with rights to sell imported medical devices in Singapore and Malaysia.
Singapore and Malaysia professional fees from SGD 1,149.
Designed for
Distributor dossier preparation
For companies with distribution rights for imported medical devices, including IVDs and diagnostics. Everest Nova prepares documentation for client submission; regulator approval remains independent.
Where projects stall
The market-access problem is usually a documentation problem first.
You hold distribution rights but the manufacturer owns most technical evidence.
Your commercial launch depends on documents you do not fully control.
Internal teams need a controlled portal for files, questions, status, and final deliverables.
What Everest Nova prepares
- Distributor intake and product pathway scoping
- Manufacturer document request list
- Technical-file organization
- Final download package
Scope and market
Everest Nova's Singapore medtech roots help bridge commercial distribution needs and technical documentation realities.
A coordinated Singapore + Malaysia bundle and both eligible local-support options are available.
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.