Which market first, in what sequence, at what price. Classification, procurement, and coding all feed that one call, and they work nothing like pharma. Vantro reads them together across 90 markets, cited to source, and hands you the decision, not another report.
Regulatory says approvable. Procurement says reimbursable. Commercial says there is demand. Each lens is right on its own, and the entry decision sits across all of them, where clear ownership rarely sits cleanly in one place. So it happens by drift rather than by design.
Vantro exists for that step. It reads the dimensions together and resolves them into one decision: enter or not, which market first, in what sequence, at what price. Every input cited, every estimate marked as an estimate.
Three things move a device launch more than market size does. Every figure below is a published regulator number, cited to source in the brief.
Singapore names five reference agencies, but the TGA and EU notified bodies collapse into one grouping. A manufacturer holding a TGA approval and a CE mark holds one independent approval, not two, and route eligibility turns on that distinction.
Malaysia’s verification route recognises seven authorities, but the device must have been marketed at least one year, same design, no recalls, no prior rejection. A recent clearance does not qualify. Singapore’s fastest routes reward three years of clean history.
Singapore needs a registrant, Malaysia an authorised representative domiciled in country, Australia a sponsor, the UAE a licensed establishment, India an authorised agent. The regulatory clock does not start until this exists.
Diagnostics is where we go deepest, and the platform covers the full range of device and software pathways alongside it.
Point-of-care, lab, and molecular diagnostics. Registration, procurement, and donor-funded channels across emerging and established markets.
From low-risk to implantable. Classification, conformity routes, and market-by-market registration pathways.
Digital health and connected devices, routed to the digital-health frameworks that apply, not pharmaceutical HTA.
Imaging, monitoring, and capital equipment, where the buyer is a procurement office and a tender, not a formulary.
Every dimension of entry behaves differently for devices. A tool built for pharma mislabels the decision. Here is where it diverges.
Classification and conformity, not drug approval. Class I to III, CE marking, 510(k), PMA, and market-specific device registration each carry their own timeline and evidence bar.Pharma track: drug and biologic approval, HTA submission.
Procurement offices, tenders, and capital budgets. Reimbursement often hinges on a procedure or billing code existing at all, not on a formulary listing.Pharma track: formularies, reference pricing, payer negotiation.
Clinical performance, usability, and often a procedure-coding crosswalk between markets. Adoption runs through clinicians and biomedical engineering, not prescribers.Pharma track: trials, real-world evidence, KOL and guideline adoption.
Reference approvals travel. A CE mark or a stringent-regulator clearance reshapes the pathway everywhere else, which changes which market to enter first.Pharma track: launch sequencing driven by pricing interdependence.
The four questions are how a market entry decision actually gets made. The six dimensions are what each answer rests on, read for a device, and rated Ready, Moderate, or Complex. No composite score.
The conformity assessment route your certificates open, whether the authority runs a reliance route, and which agencies it treats as reference.
The published clock for the route you qualify for, in the regulator’s own units, working days or statutory months, or marked as unpublished.
Who actually buys the device, ministry tender, hospital group, or distributor tier, and the registration status a bidder must hold.
How device prices are set and constrained, including tender behaviour and the effect of a first published price on the prices that follow.
The authorised representative, registrant, sponsor, or licensed establishment the market requires, and whether it must exist before the clock starts.
Import duty, customs treatment, and the free-zone question, which for devices is usually a customs and clustering decision.
Vantro runs on one body of sourced market data across 90 markets. How that data is framed, and what it leads with, differs by whether you are bringing a therapeutic or a device to market.
Run a brief on any market, or bring us the entry decision in front of you and we will scope it.