How We Work

Our Methodology

SinoBio Access follows a structured, repeatable methodology so that every product and every claim is evaluated the same way. The methodology has five stages.

Stage 1: Manufacturer Verification

Before any product is listed, we verify the manufacturer itself.

• We confirm the manufacturer identity and contact channels.
• We request manufacturer documentation: business registration, quality management system certificates (for example ISO 13485), and product-specific documents.
• We record a manufacturer verification status: unverified, documents received, under review, verified, rejected, or expired.

A manufacturer that has not supplied documentation is listed as unverified. No product claims are published for an unverified manufacturer until at least documents-received status is reached.

Stage 2: Document Collection

For each product, we collect the available manufacturer documents:

• Instructions for Use (IFU) — the official directions for operating the device.
• Technical specification sheets — claimed analytical performance parameters.
• Product brochures — marketing materials.
• Certificates — quality system and conformity certificates.

Each document is recorded as an evidence source with a source type, a visibility (public, request-only, or private), and a verification status. Documents marked request-only are listed by title but their files are never exposed publicly.

Stage 3: Evidence Classification

Every claim extracted from the collected documents is classified using two independent systems: an evidence level (A through U) that describes how reliable the supporting source is, and a claim status that describes the current verification state.

Evidence Levels (A through U)

Evidence levels describe the reliability hierarchy of a source, from highest to lowest:

A claim supported only by a manufacturer brochure is level B. A claim supported by an independently confirmed regulatory registration is level A. A claim with no supporting document at all is level U.

Claim Statuses

Claim statuses describe the current verification state of a claim:

• Manufacturer-provided information — provided directly by the manufacturer; not independently verified.
• Supported by an external source — backed by at least one external source (study, regulator, guideline).
• Document discrepancy identified — two or more sources disagree; the discrepancy is documented.
• Pending verification — verification is in progress.
• Local regulatory status not verified — local regulatory status for the market has not been checked.
• Verified for the specified market — an official regulatory document for this market has been independently confirmed.
• Source may be outdated — the supporting source may no longer be current.

Stage 4: Transparent Publication

We publish the classified evidence transparently. This means:

• Every technical parameter is labelled with its evidence level and claim status.
• When sources disagree, the conflict is documented and published, not hidden. The content carries a "document discrepancy identified" status until the conflict is resolved.
• Regulatory status in each market defaults to "not verified" and is changed only when an official document is independently confirmed.
• We do not publish promotional statements such as "FDA Approved", "WHO Approved", or "Available for purchase" without an independently confirmed source.

Stage 5: Market Access Guidance

For each target market (Russia and India), we document:

• The local regulatory pathway and the current registration status.
• The local implementation gap: what a buyer would still need to resolve (local service, documentation in the local language, local validation, supply chain).
• Practical evaluation tools: structured checklists and regulatory question guides.

Market content is strictly isolated by market so that regulatory status and local guidance are never mixed between regions.

Worked Example: iFIND Molecular Diagnostics

The iFIND molecular diagnostics platform illustrates the methodology in practice:

• The platform, the TBR kit, and the IFQ kit are documented from manufacturer brochures and instructions for use — evidence level B.
• All technical parameters (detection targets, limits of detection, turnaround time) are manufacturer-provided and labelled as "manufacturer-provided information".
• Two unresolved conflicts are documented and published: the IS1081 / IS1087 target discrepancy, and the 85-minute versus 120-minute turnaround-time discrepancy. Both carry a "document discrepancy identified" status.
• Local regulatory status in Russia (Roszdravnadzor) and India (CDSCO) is "not verified" in both cases.
• The local implementation gap is documented for each market.

What This Means for You

If you are a professional user, this methodology lets you see exactly what is verified, what is only manufacturer-claimed, and what is still unknown. You can use that information to plan your own local validation and regulatory due diligence.

For the rules that govern how claims are labelled, see Evidence Policy.